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409th Edition – June 9, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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June 9, 2020












FOUNDING MEMBER OF



Anthony D. Saleh, Ph.D., CEO of miRecule, joins Rich Bendis on BioTalk

miRecule CEO Anthony D. Saleh, Ph.D. guests on BioTalk to discuss his company, his many roles in startup companies, and being an Entrepreneur in Residence with BHI

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BioHealth Innovation Leading Five Digital RESI Conference Virtual Panels

With the LSN Digital RESI Conference approaching quickly, Event Gold Sponsor, BioHealth Innovation (BHI), is stepping up to help lead five panels with some heavy hitters from the BioHealth Capital Region (BHCR) on June 8-10, 2020.

Great Investment Opportunities in the BioHealth Capital Region

While we adjust to a COVID-19 world, there continue to be great investment opportunities in the BioHealth Capital Region. Join BHCR CEOs as they make short introductions about themselves and companies. Join CEOs from American Gene Technologies International Inc., miRecule, Adaptive Phage, Healion Bio, KaloCyte, Emocha, Tailored Therapeutics, Inc., DEKA, and Ashvattha Therapeutics, Inc.

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Sign Up Now – June EIR Feedback Session

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your complimentary virtual feedback session with BHI Entrepreneurs-in-Residence and Analysts on one of the following dates: 6/24, 7/22, 8/26. (45 minute blocks of time beginning at 9:00 in the morning. Pre-registration is required; sign up www.tinyurl.com/EIRFeedback. For questions/more information, contact BHI

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Emergent BioSolutions will produce COVID-19 vaccines in Baltimore, Rockville under $628 million federal contract – Baltimore Sun

Emergent BioSolutions Inc. will help produce COVID-19 vaccines in Baltimore and Rockville under a federal contract.

Gaithersburg-based Emergent said Tuesday it will manufacture vaccines under an existing contract with a division of U.S. Department of Health & Human Services, assisting government efforts to fast-track the vaccine. Emergent has long worked with the federal health agency’s Biomedical Advanced Research and Development Authority.

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Novavax awarded $60M Department of Defense contract for Covid-19 vaccine – Washington Business Journal

Novavax Inc. just scored even more support for its coronavirus vaccine program.

The Gaithersburg company said late Thursday it won a Department of Defense contract worth up to $60 million to help manufacture its Covid-19 vaccine candidate, NVX‑CoV2373. The funding, from the Defense Health Program, would back the production of multiple pieces of the vaccine, to be manufactured in the U.S., according to Novavax’s (NASDAQ: NVAX) announcement.

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Virginia Based AMPEL BioSolutions’ Technology Predicts Severity of Illness in COVID19 Patients and Identifies Treatments

Charlottesville, Virginia. June 9, 2020. AMPEL BioSolutions announces genomic analysis and findings that could improve treatment of COVID19 patients with approved drugs such as Embrel and Stelara. Published on bioRxiv as a preprint, the study reveals a gene-based test that will be able to determine those patients who may progress to severe illness with increased likelihood of morbidity. In addition, AMPEL’s CovGENE approach identifies FDA-approved drugs that may be appropriately repositioned to interfere with mechanisms that cause lung damage in severe COVID19 patients. The paper describes gene expression measured in three body compartments (lung, airway and blood) and integrates information from the blood and lung for a “whole body” understanding of the effects of SARS-CoV2 virus.

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AstraZeneca lays out plans to produce 2 billion doses of Covid-19 vaccine

The drug giant AstraZeneca said Thursday that it has found partners to manufacture and distribute 2 billion doses of the experimental Covid-19 vaccine created by Oxford University, inking a series of deals with non-government organizations and another manufacturer.

Image: RAPHAEL LAFARGUE/ABACA/SIPA USA VIA AP

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AstraZeneca Approaches Gilead About Potential Merger

AstraZeneca Plc has made a preliminary approach to rival drugmaker Gilead Sciences Inc. about a potential merger, according to people familiar with the matter, in what would be the biggest health-care deal on record.

The U.K.-based firm informally contacted Gilead last month to gauge its interest in a possible tie-up, the people said, asking not to be identified because the details are private. AstraZeneca didn’t specify terms for any transaction, they said. While Gilead has discussed the idea with advisers, no decisions have been made on how to proceed and the companies aren’t in formal talks, the people added.

Image: Photographer: David Paul Morris/Bloomberg

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Altimmune Launches Clinical Trial for COVID-19 Vaccine for the Treatment of Patients with Early SARS-CoV-2 infection – Biobuzz Directory

GAITHERSBURG, MD, June 1, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with a clinical trial of T-COVID, an investigational agent for the treatment of early COVID-19. Patient enrollment in the Phase 1/2 clinical trial is expected to commence in June, with data readout anticipated in Q4 2020.

T-COVID is based on the same replication-deficient adenovirus 5 (RD-Ad5) vector technology behind Altimmune’s intranasal vaccine candidates, which include NasoVAX for influenza, NasoShield for anthrax, and AdCOVID for COVID-19, but it acts through a different mechanism. In preclinical studies sponsored by the National Institute of Allergy and Infectious Diseases, intranasal administration of RD-Ad5 vectors modulated the innate immune response to lethal challenge with a respiratory virus in mice and protected them from death. The immunomodulatory effects resulted in significantly decreased cellular inflammation and lower concentrations of IL-6 and other inflammatory cytokines in the lungs of treated animals compared to controls.

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COVID-19 Vaccine Progress from 14 BioHealth Capital Region Organizations – BioHealth Capital Region – BioBuzz

Editor’s Note: This post was originally published on April 7, 2020. As updates are discovered and advancements are announced regarding the work below, details will be published for accuracy.

As the U.S. continues to find its way through a tough fight against this global pandemic, a number of BioHealth Capital Region (BHCR) biotech companies are making significant contributions to stem the COVID-19 pandemic. With people across the U.S. and the world making sacrifices to flatten the curve — along with nurses, doctors and first responders who stand heroically at the front lines — life science companies in our region are doing everything in their power to make COVID-19 vaccine progress with celerity, safety and efficacy top-of-mind.

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U.S. gives AstraZeneca $1 billion for COVID-19 vaccine candidate – UPI.com

May 21 (UPI) — European pharmaceutical company AstraZeneca said Thursday it has received more than $1 billion from the U.S. government to develop its coronavirus vaccine candidate.

The drugmaker has partnered with the University of Oxford on its “AZD1222” vaccine, one of several candidates worldwide in clinical trials.

The funding came from the the Biomedical Advanced Research and Development Authority, a branch of the Department of Health and Human Services.

Image: AstraZeneca plans at least 400 million doses and has lined up manufacturing capacity for one billion doses with first deliveries set for September. File Photo by Drago Prvulovic/EPA

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AstraZeneca Ranked Most Inventive, Roche Most Innovative

AstraZeneca (AZN) was ranked the most the most inventive pharmaceutical company for the second year in a row by IDEA Pharma’s Invention and Innovation Index for 2020. Meanwhile, Roche (RHHBY) jumped seven places from its 2019 ranking to capture the top spot in the list of most innovative pharma firms.

IDEA is an international consulting firm that works with pharma companies to position their products in the early phase to maximize market success and consult on innovation. The firm bases its Innovation Index on the answer to the following question: “If two companies had the same molecule, who would be more successful with it?” It also considers their ability to bring products from phases 1 and 2 to market and commercialize them successfully, according to CEO Mike Rea.

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CEOs, Academics Step Out to Fill National Leadership Void – Maryland Matters

Amid a wrenching series of crises that have riven the nation, particularly over matters of race and law enforcement, corporate leaders throughout Maryland have voiced support for the social justice movement that has become more urgent and grown after the death of George Floyd.

Over the last few days, corporate CEO’s, university leaders and others have acknowledged the pain that Americans of all stripes are experiencing, and have pledged to be part of the solution.

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NodThera Announces Close of $55 Million Series B Financing

Financing round led by Novo Ventures and includes new investors Cowen Healthcare Investments and Sanofi Ventures, as well as existing investors 5AM Ventures, F-Prime Capital, Sofinnova Partners and founding investor Epidarex Capital

Proceeds to support advancement of pipeline of small molecule NLRP3 inflammasome inhibitors, including continued progression of NT-0167 through clinical development

CAMBRIDGE, UK, BOSTON & SEATTLE – June 3, 2020 – NodThera, a clinical stage biotechnology company developing a new class of medicines that inhibit the NLRP3 inflammasome to treat diseases driven by chronic inflammation, today announced that it has secured $55 million (£44 million) in a Series B financing. NodThera’s lead candidate, NT-0167, is being evaluated in a Phase 1 clinical trial in healthy volunteers.

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Pfizer Establishes New Program to Support Continued Biotechnology Innovation | Business | oleantimesherald.com

Pfizer Inc. (NYSE: PFE) today announced the establishment of the Pfizer Breakthrough Growth Initiative, through which Pfizer will invest up to $500 million in biotechnology companies to help provide funding and access to Pfizer’s scientific expertise to ensure continuity of the biotechnology companies’ most promising clinical development programs.

“There has never been a more important moment to pursue new collaborations in our industry,” said John Young, Pfizer’s Chief Business Officer. “The Pfizer Breakthrough Growth Initiative seeks to do just this by injecting crucial capital into biotechnology companies that share our commitment to delivering transformative therapies for patients.”

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Global Deaths Due to Various Causes and COVID-19

Always good to see a new relational perspective. #perspective #thinking #reflection #designthinking #innovationculture

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VCs Cautious of “COVID-19 Contortionists” and Telemedicine “Gold Rush” · BioBuzz

COVID-19 is fundamentally changing how we live, how we do business, and how we approach and deliver our healthcare. In the past 14 weeks, there has been unprecedented growth for a segment of companies who were positioned to meet these rapidly sweeping changes to our lives, while so many others have had to close their doors or are fighting to stay in business. COVID-19 has sparked millions of job losses.

Image: https://biobuzz.io

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SARS-CoV-2 Infection Mapped through Respiratory Tract

SARS-CoV-2 is known to infect cells of the respiratory tract. A deeper understanding of which cells support the infection, and to what extent, could lead to insights into disease progression and severity. Scientists at the UNC School of Medicine sought to understand which cells in the airway the virus infects, and how it gets into the lungs in the patients who develop pneumonia. To this end, they have characterized some of the ways in which SARS-CoV-2 infects the nasal cavity and infects and replicates progressively less well in cells lower down the respiratory tract—including the lungs.

Image: SARS-CoV-2 (red) infected ciliated cells in the COVID-19 patient’s bronchi. (Takanori Asakura, PhD, UNC School of Medicine)

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Novavax Awarded Department of Defense Contract for COVID-19 Vaccine Nasdaq:NVAX

GAITHERSBURG, Md., June 04, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the company has been awarded a contract by the U.S. Department of Defense (DoD) for the manufacturing of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.

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Home | About BHI | BHI News | Programs | Partners | Contact

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All Rights Reserved.



410th Edition – June 16, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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June 16, 2020












FOUNDING MEMBER OF



Fina Biosolutions Receives SBIR Matching Grant from Montgomery County, MD

Fina Biosolutions recently received a $25,000 Montgomery County SBIR/STTR Phase I matching grant to support its NIH SBIR grant focused on “Genetically detoxified tetanus toxin for use in vaccines.” The grant comes from a subprogram of the Montgomery County Economic Development Fund. Andrew Lees, Fina Biosolutions’ Scientific Director said, “we are very grateful for the County’s support for our research. We intend to use the funds to hire a part-time employee who we expect will transition to full-time. We also are appreciative of the assistance we received from BioHealth Innovation in guiding us through the County grant process”. Fina Biosolutions is developing the genetically detoxified tetanus toxin as a carrier protein for peptide and glycan conjugate vaccines. Montgomery County, Maryland is the first county in the U.S. to offer matching grants to NIH SBIR/STTR awardees to further leverage the public and private investment in their R&D and job growth activities.

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Sign Up Now – June EIR Feedback Session – Only one spot left!

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your complimentary virtual feedback session with BHI Entrepreneurs-in-Residence and Analysts on one of the following dates: 6/24, 7/22, 8/26. (45 minute blocks of time beginning at 9:00 in the morning. Pre-registration is required; sign up www.tinyurl.com/EIRFeedback. For questions/more information, contact BHI

 

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Viela Bio Announces U.S. FDA Approval of UPLIZNA™ (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) Nasdaq:VIE

GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) — Viela Bio (Nasdaq:VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNATM (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. Approximately 80%1 of all patients with NMOSD test positive for anti-AQP4 antibodies.

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Glyscend Therapeutics Completes $20.5M Financing Round to Advance Novel Oral Polymer Therapy for Type 2 Diabetes

BALTIMORE, June 11, 2020 (GLOBE NEWSWIRE) — Glyscend Therapeutics, a privately held biopharmaceutical company developing novel treatments for type 2 diabetes (T2D) and related metabolic conditions, today announced the closing of a $20.5 million Series A financing round. Healthcare investors Brandon Capital Partners, through its Medical Research Commercialisation Fund (MRCF), and Santé Ventures led the round of funding, which will be used to support the development of the company’s novel oral polymer therapy for patients with T2D and other metabolic diseases. Breakout Labs (a fund in the Thiel Foundation) provided seed funding in 2019.

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AstraZeneca taps Emergent as U.S. partner for potential COVID-19 vaccine – Reuters

AstraZeneca has inked manufacturing deals globally to meet its target of making 2 billion doses of the vaccine, including with two Bill Gates-backed ventures and a $1.2 billion agreement with the U.S. government.

The company’s vaccine is among the first to move into mid-stage trials and the first indication of its effectiveness would likely be available in June or July. There are no approved vaccines or treatments for COVID-19, the highly contagious respiratory illness caused by the novel coronavirus.

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2020 AURP BIO HEALTH CAUCUS – Supporting the Growth of Bio Health Innovation Districts Worldwide – RECAP

At AURP’s BIO Health Caucus, we explored trends in life science research, opportunity zone funding resources, the marriage of life science and philanthropy in global partnership opportunities. Discover the unique roles that biomedical innovation cluster and research parks play in innovation ecosystems around the globe. Translating discoveries from the lab to the market has never been more important.

Click here to download the PDF

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KaloCyte raises $300K from Maryland Momentum Fund – Technical.ly Baltimore

Less than a year after relocating its headquarters to Baltimore, biotech company KaloCyte has raised new funding from Maryland-based investors and expanded its local team.

On Monday, the company announced that it raised $300,000 from the Maryland Momentum Fund, which is a venture fund created by the University System of Maryland that invests in affiliated companies. It is part of a larger funding round for the preclinical-stage company, which is developing an artificial red blood cell substitute. Called ErythroMer, it can be used in situations where stored red blood cells are not available, such as treating trauma when patients have a need for blood.

Image: Baltimore’s BioPark is part of the University System of Maryland. (Courtesy photo)

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Sirnaomics to spin off RNAimmune to develop novel mRNA therapeutics and vaccines – Maryland Daily Record

Sirnaomics Inc., a Gaithersburg-based biopharmaceutical company engaged in the discovery and development of RNAi therapeutics, Friday announced a corporate technology spinoff establishing an independent biopharmaceutical company, RNAimmune Inc. This new entity is focusing on and specializing in messenger RNA (mRNA) based therapeutics and vaccine development, with exclusively licensed Polypeptide-Lipid Nanoparticle (PLNP) delivery technology and large scale …

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BRIEF-Novo Nordisk To Acquire Corvidia Therapeutics – Reuters – congrats to Ram Aiyar former BHI EIR

* NOVO NORDISK TO ACQUIRE CORVIDIA THERAPEUTICS AND EXPAND PRESENCE IN CARDIOVASCULAR DISEASE

* UNDER TERMS OF AGREEMENT, NOVO NORDISK WILL ACQUIRE ALL OUTSTANDING SHARES OF CORVIDIA THERAPEUTICS FOR AN UPFRONT PAYMENT OF 725 MILLION US DOLLARS IN CASH

 

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Emmes Announces Its Work on a Phase 3 Clinical Trial for Breakthrough Therapy Designation Product | BioSpace

ROCKVILLE, Md., June 15, 2020 /PRNewswire/ — Emmes Group today announced that it provided the Phase 3 clinical trial support for a new investigational cell therapy that offers a promising treatment opportunity for patients who need an allogeneic bone marrow transplant. Emmes’ work for Gamida Cell Ltd., an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, involved full scope clinical trial support for this study that was conducted at more than 50 centers in the United States, Latin America, Europe and Asia. Emmes also supported the early development Phase 1 and 2 trials that began in 2010.

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Charlottesville company develops test to predict most severe cases of COVID-19

CHARLOTTESVILLE, Va. (WVIR) – The COVID-19 pandemic has presented many complex challenges to those in the medical field. One Charlottesville-based company stepped up to the plate to come up with a solution beyond just testing for the virus.

AMPEL BioSolutions typically does personalized medicine for Lupus patients, but when the pandemic struck scientists switched gears: They went beyond just developing a “positive or negative” coronavirus test. Scientists with AMPEL say they have developed technology to predict whether a patient will have mild or severe symptoms, which could be life-saving.

Image: (FILE) (Source: MGN Image) – https://www.nbc29.com

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2020 Life Science Venture Capital Funding Roundup for Q1/Q2 in the BioHealth Capital Region · BioBuzz

This has certainly been a year unlike any other for BioHealth Capital Region (BHCR) life science companies of all sizes and kinds. Just a few months into 2020, the coronavirus pandemic swept the region, seriously disrupting, albeit temporarily, the best laid plans of aspiring founders, entrepreneurs, emerging startups, pre-clinical and more established, larger biohealth organizations in Virginia, Washington, D.C. and Maryland.

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FSIF COVID BIOSCIENCE APPLIES FOR PATENT ON INNOVATIVE NEW COVID-19 TEST

<p>Cambridge, MD, June 15 — FSIF COVID BioScience, a biotechnology company focused on harnessing the power of the human immune system to diagnosis and treat Covid-19, announced today that it just filed a new patent for the Company’s innovative FSIF(FullSpectrumInterferonFingerprint)COVID-19test. While thetechnology behind thisnewly filed patent will serve as an accurate diagnostic for COVID-19, its real value is the ability stratify patients into degrees of disease severity as noted in the grid below:

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Maryland Stem Cell Research Commission Announces over $7 Million in awards to Accelerate Cures | MSCRF

COLUMBIA, Md. (June 5, 2020)— The Maryland Stem Cell Research Commission (Commission) has approved funding to its second round of 2020 recipients for a total of $ 7,053,759. The Commission has also issued a Request for Applications (RFAs) for its first round of funding for fiscal year 2021 and is looking to continue accelerating cutting-edge research and cures through the Maryland Stem Cell Research Fund (MSCRF).

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PathSensors Inc. Announced the Completion of Phase I of a SBIR

PathSensors Inc., a Baltimore biotechnology company, announced today the completion of Phase I of a Small Business Innovation Research (SBIR) program funded by the National Institute of Food and Agriculture (NIFA) entitled “Food Safety in the 21st Century: Rapid Toxin Detection in the Field”. The project’s goal was to engineer and develop a field-deployable instrument for portable pathogen and toxin detection.

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SilcsBio and Dalriada Drug Discovery Launch Partnership to Create a Rapid Drug Discovery Service Suite | Press Release | I95 Business

June 11, 2020, Baltimore, MD and Toronto, ON – SilcsBio, a technology company that develops innovative software and provides services for structure-based drug design, and Dalriada Drug Discovery, a full service small molecule drug discovery contract research organization supporting global innovators through its TURN-KEY™ model, today announced the launch of a formal partnership to enable enhanced support for their clients’ programs.

Under the new partnership, SilcsBio’s expertise in computer-aided drug design (CADD) will be vertically integrated with Dalriada’s world-class wet-lab drug discovery capabilities accelerating clients’ target-directed programs. Through close work between the two expert scientific teams and integration of CADD, medicinal chemistry, target screening, and ADME, clients can expect accelerated hit identification, lead generation, and lead optimization cycles.

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Immunomic Therapeutics to Present at AACR Virtual Annual Meeting II – Immunomic Therapeutics

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc. will present preclinical data on its investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression), that elicits potent immune responses when used with its investigational UNITE vaccine, ITI-3000, in mice. UNITE fuses a tumor-associated antigen, here a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV), with lysosomal-associated membrane protein 1 (LAMP1). This lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response, as ITI-3000 activated antigen-specific CD4+ T cells in vivo. The data will be presented at the AACR Virtual Annual Meeting II, June 22-24, 2020.

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FDA Grant and Gift from Entrepreneur Provide $250K in Awards for Pediatric Medical Device Competition Focused on COVID-19 Innovations | Benzinga

WASHINGTON, June 11, 2020 /PRNewswire/ — As medical data increasingly highlights the serious impact of COVID-19 on children’s health, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces a special pitch competition focused on COVID-19-related pediatric medical devices that support home health monitoring and telehealth, and improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic.

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The Top Biotech Companies That are Hiring – June 2020 · BioBuzz

Despite the uncertainty created by the COVID-19 pandemic, companies across the BioHealth Capital Region (BHCR) continue to hunt for talented life science professionals to advance their technologies, produce their commercial products for the patients that need them, and for many they are also supporting COVID-19 vaccine and diagnostic efforts that the whole world is counting on.

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We shouldn’t care who wins the vaccine ‘race’ – The Washington Post

Regarding the June 4 front-page article “Cold War echoes in race for vaccine,” about the “race” among nations, notably the United States, China, and Russia and other European nations for development of a vaccine against the novel coronavirus:

When communicating about vaccines and dates, leaders should be careful to note that this means candidate vaccines. We actually have a vaccine only after it is proved effective and safe over a long period, requiring time (years, not months), durability (e.g., the measles vaccine lasts a lifetime whereas some others are much shorter), a formula that covers all or most strains (especially those recurring seasonally) and feasibility (cost, global availability, etc.).

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Covid-19 vaccine price controls would scare off developers, Fauci says at BIO – MedCity News

As multiple companies work to develop vaccines against the virus that causes Covid-19, it will be important for them to work with the federal government toward an understanding with regard to fair pricing, but outright price controls could risk scaring companies away, a doctor helping lead efforts to develop drugs and vaccines for the disease told biotech industry executives Tuesday.

Image: https://medcitynews.com

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Johns Hopkins to resume on-campus lab research next week | Hub

Johns Hopkins University researchers will be permitted to resume on-site laboratory activities beginning next week, the first steps of a gradual resumption of on-campus activities envisioned in the weeks and months ahead as the university emerges from a monthslong period of distancing prompted by the COVID-19 pandemic.

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Covid-19 roundup: Fauci talks pricing, disparate impact and the virus’s enduring mysteries; China to offer experimental vaccines to overseas workers – Endpoints News

Multiple vaccines will ultimately be approved for Covid-19, NIAID chief Anthony Fauci told BIO yesterday, and the companies that make them should be allowed to profit, “as long as it’s not in an outrageous way.” Sitting down for a rare extended interview with new BIO chief Michelle McMurry-Heath,

Image: NIAID chief Anthony Fauci (AP Images)Image: https://endpts.com

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The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life | BIO

This ninth biennial TEConomy/BIO report focuses on the economic footprint of the industry geographically including the latest trends in the bioscience industry for the nation, states, and metropolitan areas. Check out state-by-state information on the performance of the bioscience economy.

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Congratulations to Our Digital RESI June Innovation Challenge Winners! | Next Phase Newsletter

Our 3-day Digital RESI June conference came to an end yesterday, and we are very excited to announce the Top 3 Winners of the Innovation Challenge. Each participating finalist company had a dedicated page where you could view their virtual poster, short pitch, and other supplementary materials that the companies made available for viewing.

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Producing Enough Vaccine For The Coronavirus Means Companies Have To Start Now : Shots – Health News : NPR

Once upon a time, developing a new vaccine was a step-by-step process that went from concept, to design, to tests in humans, to regulatory approval, to manufacturing.

It was a process that could take a decade or more.

But the urgent need for a COVID-19 vaccine has radically changed all that. Now, the hope is the entire process can be completed in a year or less.

Image: Cell culture operators prepare a 2000-liter single-use bioreactor to produce proteins used to make vaccines. Philip Taciak/Emergent Biosolutions

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NIH announces $1 million prize competition to target global disease diagnostics

The National Institutes of Health has launched a $1 million Technology Accelerator Challenge (TAC) to spur the design and development of non-invasive, handheld, digital technologies to detect, diagnose and guide therapies for diseases with high global and public health impact. The Challenge is focused on sickle cell disease, malaria and anemia and is led by NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). The Bill & Melinda Gates Foundation is cooperating with NIH to help accelerate the transformation of design concepts into products for low-resource settings.

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Can you catch Covid-19 from someone without symptoms? — Quartz

On Monday, June 8, an official at the World Health Organization (WHO) made a surprising statement. People who have Covid-19 but are asymptomatic—meaning they never develop symptoms like fever, coughing, or gastrointestinal distress—very rarely gave it to others, stated Maria Van Kerkhove, the WHO’s technical lead on the Covid-19 pandemic, at a regularly-scheduled press briefing.

The very next day, the organization took it back. Some might have taken WHO’s original statement to mean that “stealth transmission” of Covid-19 is unlikely—that if a person isn’t actively coughing and sneezing, you don’t need to worry about getting infected. But that’s not necessarily the case. On June 9, WHO clarified that while most transmission seems to come from people showing symptoms, it’s too soon to know exactly how the virus spreads.

Image: AP PHOTO/PETROS KARADJIAS – https://qz.com/

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BioHealth Capital Region Spotlighted at RESI

The BioHealth Capital Region featured at last week’s Redefining Early Stage Investments Conference (RESI) where speakers from the region discussed a range of topics of interest to early stage companies including:

For more information, check out the RESI Conference site or contact BHI.

 

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Creatv Announces Ability to Predict Immunotherapy Treatment Response for Non-Small Cell Lung Cancer (NSCLC) using a Simple Blood Test | Business Wire

ROCKVILLE, Md.–(BUSINESS WIRE)–Creatv Microtech, a privately-held biotechnology company has pioneered a blood test to predict treatment response in patients with stage II-III NSCLC treated with chemoradiation therapy (CRT) and consolidated immunotherapy. Clinical data presented at the ASCO 2020 virtual annual meeting shows the ability to predict which NSCLC patients will benefit from anti-PD-L1/PD-1 immunotherapies. “We are delighted to present a method to stratify patients responding to immunotherapy by a single tube of blood collected after completion of CRT,” said Dr. Cha-Mei Tang, CEO of Creatv. “Early identification of patients that do not respond to immunotherapy will reduce unnecessary patient suffering from ineffective and costly treatment, allowing patients to proceed to alternative therapies.” Currently, no other blood test can predict immunotherapy treatment response for lung cancer.

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AstraZeneca, Emergent BioSolutions sign $87M deal to produce U.S. supply of COVID-19 vaccine | FiercePharma

AstraZeneca made waves last week when it signed a massive $750 million deal to ramp production of a University of Oxford COVID-19 vaccine up to 2 billion doses per year. Now, as part of a Trump administration effort to get shots into U.S. hands as soon as possible, AstraZeneca has agreed to another major manufacturing tie-up.

Image: AstraZeneca agreed to dole out $750 million last week to boost its COVID-19 shot capacity to more than 2 billion doses. (AstraZeneca)

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2017
All Rights Reserved.



411th Edition – June 23, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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June 23, 2020












FOUNDING MEMBER OF



Charles Andres and Christian Barrow join BioTalk to discuss investing, growth and the BioHealth Capital Region during COVID-19

Charles Andres, Ph.D., RAC, Associate at Wilson Sonsini Goodrich & Rosati, and Christian Barrow, Executive Director, Life Sciences Banking at JP Morgan, join Rich Bendis for a Virtual BioTalk

Charles Andres, Ph.D., RAC, is an associate in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati. He focuses on patent prosecution, strategic patent counseling, IP due diligence, drug and medical device FDA regulatory counseling, invalidity and non-infringement opinions, life-cycle management, Supreme Court and Federal Circuit amicus briefs, and related business matters.

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The BioHealth Capital Region Featured at Digital RESI LSN Global Conference

The Life Science Network’s Digital Redefining Early State Investments (RESI)  took place online June 8-10, 2020, and featured some of the most knowledgeable voices from the BioHealth Capital Region. The region was well represented across four panels titled:

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AstraZeneca taps Catalent for COVID-19 vaccine finishing, packaging at Italian plant | FiercePharma

British drugmaker AstraZeneca is shooting for the moon with its plan to produce 2 billion doses per year of a potential COVID-19 vaccine. To reach that lofty goal, AstraZeneca has reached a deal with New Jersey-based Catalent to help with the final stages of the shot’s manufacturing.

Catalent will be tasked with finishing and packaging duties for AstraZeneca and the University of Oxford’s COVID-19 vaccine candidate, AZD1222, at its 305,000-square-foot manufacturing facility in Anagni, Italy, the CDMO said Monday.

Image: Catalent will be tasked with helping finish and package AstraZeneca’s COVID-19 vaccine candidate. (Catalent)

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Emergent Bio to invest $75M in Canton site (NYSE:EBS) | Seeking Alpha

Emergent BioSolutions (NYSE:EBS) will invest $75M in its Canton, Massachusetts facility, focused on the development and manufacturing of drug substance for live viral vaccines and plans to expand into viral vector and gene therapy.

The investment will include a state-of-the-art, multi-suite operation up to 1000L scale.

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Rexahn and Ocuphire Enter into Definitive Merger Agreement :: Rexahn Pharmaceuticals, Inc. (REXN)

ROCKVILLE, Md. and FARMINGTON HILLS, Mich., June 17, 2020 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NasdaqCM: REXN) and Ocuphire Pharma, Inc., a privately-held clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of eye disorders, today announced the companies have entered into a definitive merger agreement under which Ocuphire will merge with a wholly-owned subsidiary of Rexahn in an all-stock transaction. Following closing, which is expected to occur in the second half of 2020, the combined company will change its name to Ocuphire Pharma, Inc. and is expected to trade on the Nasdaq Capital Market under the ticker symbol “OCUP.” The combined company will focus on the advancement of its pipeline of ophthalmic drug candidates.

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Emmes Chosen as a Top Area Workplace

ROCKVILLE, Md., June 17, 2020 /PRNewswire/ — Emmes today announced that it was selected as one of the best places to work in the greater Washington area. The Washington Post’s 2020 Top Workplaces list ranked private, public, nonprofit and government agencies based on the highest engagement ratings from their employees.

The Washington Post partnered with employee research and consulting firm Energage, LLC, to conduct the survey, and the highest ranked workplaces were chosen based on employee responses about their own company. There were 3,500 area companies invited to participate, and 406 were surveyed. This is the seventh year the survey has been conducted.

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Sirnaomics and Precision NanoSystems Have Formed a Partnership | BioSpace

Developing and Manufacturing Novel RNAi drug Candidates Using Precision NanoSystems’ NxGen™ Platform

GAITHERSBURG, MD and VANCOUVER, BC, June 17, 2020 /PRNewswire/ – Sirnaomics Inc. (Sirnaomics) and Precision NanoSystems Inc. (PNI) jointly announced a partnership on the development and manufacture of Sirnaomics polypeptide nanoparticle-based RNAi therapeutic product. This strategic joint effort includes the execution of a NanoAssemblr® platform license and supply agreement, plus successful production of multiple batches of Sirnaomics drug product candidates, STP705 and STP707, for ongoing IND enabling safety and toxicity studies, as well as several clinical studies.

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ITI Enters into License Agreement with Ichor to Use Electroporation (EP) Delivery Technology in Phase I Study of DNA Vaccine Therapy, ITI-1001 – Immunomic Therapeutics

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms and Ichor Medical Systems (“Ichor”), a privately held biotech company based in San Diego, CA, announced today that the companies have entered into a license agreement to support the development of ITI’s investigational plasmid DNA vaccine therapy, ITI-1001.

ITI will leverage Ichor’s TriGrid® Electroporation technology to increase cellular uptake of ITI-1001 when administered to patients with newly diagnosed Glioblastoma, or GBM. DNA vaccines delivered by conventional injection have experienced challenges to delivery efficiency, resulting in suboptimal immune responses in clinical trials. Ichor’s TriGrid technology utilizes the application of electrical fields in a target tissue to increase intracellular nucleic acid uptake in the local area, resulting in enhanced gene expression.

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Children’s National Hospital ranked a top 10 children’s hospital and No. 1 in newborn care nationally by U.S. News for fourth year in a row

WASHINGTON, June 16, 2020 /PRNewswire/ — Children’s National Hospital in Washington, D.C., was ranked No. 7 nationally in the U.S. News & World Report 2020-21 Best Children’s Hospitals annual rankings. This marks the fourth straight year Children’s National has made the list, which ranks the top 10 children’s hospitals nationwide. In addition, its neonatology program, which provides newborn intensive care, ranked No.1 among all children’s hospitals for the fourth year in a row.

The Children’s National Hospital neonatology program, which provides newborn intensive care, ranked No.1 in the nation by U.S. News for the fourth year in a row.

Children’s National Hospital ranked a top 10 children’s hospital and No. 1 in newborn care nationally by U.S. News for fourth year in a row

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Altimmune Announces IND Clearance for a Phase 2 Trial of HepTcell™ Immunotherapeutic for the Treatment of Chronic Hepatitis B | BioSpace

GAITHERSBURG, Md., June 22, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B. The Company is also filing clinical trial applications in Canada, Spain, Germany and the United Kingdom. Altimmune plans to initiate a multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct.

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Preclinical Data for PRGN-3005 UltraCAR-T® Demonstrate Superior Expansion and Persistence of UltraCAR-T Compared to Traditional CAR-T | BioSpace

GERMANTOWN, Md., June 22, 2020 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced preclinical data for its innovative investigational PRGN-3005 UltraCAR-T® in patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer has been published as an e-poster and accompanying audio presentation at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. The e-poster presentation titled PRGN-3005 UltraCAR-T: Multigenic CAR-T Cells Generated Using Non-viral Gene Delivery and Rapid Manufacturing Process for the Treatment of Ovarian Cancer (Abstract 6593) is part of the Immunology/Adoptive Cell Therapy session and is accessible on the AACR e-poster website.

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Emergent to add gene therapy capacity – Bioprocess InsiderBioProcess International

Emergent Biosolutions has set out to capture a share of the expanding viral vector and gene therapy sector.

The US countermeasures developer said it will spend $75 million to add viral vector and gene therapy manufacturing capacity at a facility in Canton, Massachusetts.

At present the plant – which was acquired from Sanofi in 2017 – produces drug substance for live viral vaccines, including Emergent’s smallpox jab ACAM2000.

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CrazyCap helps Martine Rothblatt Cheer On Her Team Through Crisis! – PharmiWeb.com

MIAMI, June 22, 2020 /PRNewswire/ — Esteemed lawyer, author, and entrepreneur, Martine Rothblatt, Ph.D., found a thoughtful and practical way to thank her employees at United Therapeutics, who have been going above and beyond during this time of the coronavirus crisis. The team at United Therapeutics, a biopharmaceutical company, has always been dedicated to working hard on life-saving biotech innovations. During the global coronavirus pandemic, United Therapeutics has recognized the dire need to develop treatments for COVID-19 patients and has responded quickly by initiating three projects intended to help with COVID-19, including an artificial lung technology that could help avoid the need for the use of ventilators.

Image: https://en.wikipedia.org/wiki/Martine_Rothblatt

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GMU selects three finalists for $250M Institute for Digital InnovAtion | Virginia Business

George Mason University on Monday announced three development and property management firms as finalists to build and operate its proposed $250 million Institute for Digital InnovAtion (IDIA), set to open in September 2025 on its Arlington campus. The university released a request for proposals in February, to which 105 developers responded.

Image: Concept rendering of George Mason University’s Institute for Digital InnovAtion (IDIA) in Arlington – https://www.virginiabusiness.com

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AstraZeneca agrees to make Covid-19 vaccine for Europe | BreakingNews.ie

Pharmaceutical giant AstraZeneca has struck a deal with Europe’s Inclusive Vaccines Alliance to supply up to 400 million doses of an experimental Covid-19 vaccine, as efforts to boost manufacturing capacity continue at pace.

The alliance, which was forged by Germany, France, Italy and the Netherlands to speed up production of a vaccine, is set to take delivery of the material being tested by the University of Oxford by the end of 2020.

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University of Maryland Medical System awarded $18.7 million federal grant to fight coronavirus – Baltimore Sun

The University of Maryland Medical System will receive more than $18.7 million in funding from the Federal Emergency Management Agency (FEMA) in the ongoing effort to combat the coronavirus, the arm of the U.S. Department of Homeland Security announced Monday.

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GSK gets FDA approval for HIV drug for children – MarketWatch

Shares of GlaxoSmithKline GSK, +0.36% were down 0.05% in premarket trading on Monday after the Food and Drug Administration late on Friday approved its HIV drug Tivicay as a treatment for infants and children. Tivicay is the company’s second-best selling drug in its HIV portfolio. About 2,200 children in the U.S. had been diagnosed with HIV in 2016, according to statistics provided by the Centers for Disease Control and Prevention. GSK’s stock has gained 14.9% since the start of the year. The S&P 500 SPX, -0.56% is down 5.8% year-to-date. The FDA is granting the approval of Tivicay and Tivicay PD to ViiV Healthcare.

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Novavax Appoints Biotechnology Veteran David Mott to Board of Directors | Novavax Inc. – IR Site

GAITHERSBURG, Md., June 16, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has appointed David Mott as an independent director to its Board of Directors. Mr. Mott brings more than three decades of global management, board and investment experience across numerous private and public biopharmaceutical companies. Prior to February 2020, he was the global head of healthcare investing at New Enterprise Associates (NEA).

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Advisory Board | Johns Hopkins Technology Ventures

The IDEA Board champions innovation and entrepreneurship across the Johns Hopkins University, providing the vision and strategy by which Johns Hopkins will bring the next generation of discoveries to market. This group of stakeholders from industry, academia, startups, and the broader ecosystem is also helping to catalyze new economic activity and partnerships that will build a better Baltimore.

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GSK Expands Synthetic Lethality Scope With $120M Ideaya Bio Alliance – Xconomy

GlaxoSmithKline got its first taste of synthetically lethal cancer therapies via an acquisition. Now it’s trying for a bigger bite of this emerging drug class through a research alliance with Ideaya Biosciences that spans three of the biotech’s programs, all slated to reach clinical trials in the next three years.

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Emergent BioSolutions Adding Approximately 300 Jobs After New COVID-19 Vaccine Contracts

Business is booming for Emergent BioSolutions as it has assisted in the country’s push to create COVID-19 treatments and vaccines. Emergent is developing two plasma-based treatments for COVID-19 and has partnered with four companies on vaccine candidates. It is additionally partnering with the Federal Government to develop and manufacture COVID-19 vaccines. As a result of this wave of new business, the company is hiring approximately 300 new employees in Baltimore and Rockville.

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Emergent BioSolutions Enters Viral Vector And Gene Therapy Arena – Contract Pharma

Emergent BioSolutions has unveiled plans to strengthen its contract development and manufacturing (CDMO) capabilities by expanding into viral vector and gene therapy. The company will invest $75 million in its Canton, MA facility, which is focused on the development and manufacturing of drug substance for live viral vaccines, including the company’s smallpox vaccine.

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Lockheed’s ventures arm backs quantum computing and training tech firms — Washington Technology

Lockheed Martin Ventures — the defense company’s technology startup investment arm — has backed two companies through separate avenues announced this week.

In a release Tuesday, quantum computing company IonQ said it grew its total fundraising amount to $84 million through a new Series B round that represents its second significant round of investments since the 2015 founding with $2 million in seed money.

Image: https://washingtontechnology.com

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Royalty Pharma, drug firm that doesn’t develop drugs, shatters IPO record

Royalty Pharma, a business built on investing in other people’s medicines, raised $2.2 billion in a record IPO on Tuesday, and the early hours of trading boosted its valuation to more than $25 billion.

The company, founded in 1996, priced about 78 million shares at $28 each. Royalty Pharma opened trading at $44, an instant 57% increase, suggesting the company’s bankers left a fair amount of money on the table.

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BIA | EPIDAREX CAPITAL CLOSES NEW £102 MILLION UK VENTURE FUND TO BUILD SUCCESSFUL LIFE SCIENCE COMPANIES

Edinburgh, UK, 22 June 2020 – Epidarex Capital (“Epidarex”), a transatlantic life science venture firm, announces that it has closed Epidarex Capital III UK LP (the “Fund”) at £102.1 million. The Fund will build new life science companies based on world-class research and innovation from emerging hubs across the UK, including spinouts from highly regarded universities. Typical initial investments will range from £2 million to £5 million.

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All Rights Reserved.



402nd Edition – April 21, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


April 20, 2020












FOUNDING MEMBER OF



Biohealth Innovation – COVID-19 Resources

In these uncertain times, we are proud to have so many BioHealth Capital Region federal, state, local and private sector organizations focused on combatting COVID19. Please use these links to stay abreast of the last news and resources available for your business.

District of Columbia

Maryland

Montgomery County, MD

Virginia

US Small Business Administration

Volunteers

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Entrepreneur-in-Residence Feedback Session

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? There are a couple openings remaining for tomorrow (Wednesday) ‘s EIR session. Schedule your feedback session with BHI EIRs by videoconference here by 2 p.m. today, Tuesday and forward your power point deck to BHI at that time. Next month’s session is scheduled for May 27th.

Click here to schedule a time with us and send your slide deck to: bhi(at)biohealthinnovation.org.

Contact Judy Costello for more information.

E:  jcostello(at)BioHealthInnovation.org

P: 301.637.8854P: 301.637.8854

 

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AstraZeneca Donates 3 Million Surgical Masks to Direct Relief for Covid-19 Supply Needs in the U.S.

Direct Relief today announced a donation from AstraZeneca of 3 million surgical masks for US healthcare workers battling Covid-19.

“For the dedicated and courageous healthcare workers across this country treating Covid-19 and non-Covid19 patients, working without an adequate supply of face masks and other protective equipment is like going into battle without body armor,” said Direct Relief CEO Thomas Tighe. “This generous and timely donation from AstraZeneca will make a substantial difference in keeping these vital workers safe and able to continue providing care for us all.”

Image: Pallets of surgical masks, donated by AstraZeneca, are prepared at Direct Relief’s global distribution facility in California for delivery via FedEx to health workers battling Covid-19 across the United States. (Photo: Direct Relief)

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JLABS @ Washington D.C.: A Healthcare Incubator With a Focus on Pandemics | Johnson & Johnson

It was a year ago this month that Johnson & Johnson Innovation first unveiled plans to launch a healthcare innovation facility in Washington, D.C., in collaboration with BARDA—also known as the Biomedical Advanced Research and Development Authority, a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

BARDA’s mission: the innovation, advanced research and development, acquisition and manufacturing of medical countermeasures—vaccines, drugs, therapeutics, diagnostic tools and non-pharmaceutical products—needed to protect us from chemical, biological, radiological and nuclear (CBRN) health security threats, as well as pandemic influenza and emerging infectious diseases.

Image: Photo courtesy of Children’s National Hospital

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Aledade raises $64M in Series C, supports doctors with COVID supplies – Washington Business Journal

Bethesda’s Aledade Inc. has done it again.

The fast-growing health tech startup, which helps physician practices cut costs and build accountable care organizations, has raked in a whopping $64 million in Series C financing, after kicking of 2019 with $56 million in then-new investments — and all in a moment of general investor restraint.

The funding will enable Aledade to continue expanding its national network of doctor-led ACOs, the company said Monday. It will also support the addition of more value-based contracts with Medicare, Medicaid and commercial health plans. It comes as Aledade sees annual revenue grow 60% and projects it will surpass $150 million within the next year, it said in an email to the WBJ.

Image: Farzad Mostashari is the CEO and founder of Aledade. JOANNE S. LAWTON

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200 Investors for Tech Hubs

RESI is planning its first ever, dedicated, digital partnering event on April 29-30th with over 200 investors participating! We’re offering a special opportunity to our tech hubs to help your companies continue their business development in these difficult times. If you are able to promote this event among your constituents, we would like to offer them the possibility to register at a 50% discount, good until April 17th. That means the registration for 2 full days of partnering will cost less than $300!

Special 50% Discount Offer for Tech Hub Constituents (2-Day registration only, ends April 17th) Registration price $595 = $297.50

REGISTER HERE Discount Code: RESITH50

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Medcura moves into New Corporate HQ

RIVERDALE, Md., April 17, 2020 /PRNewswire/ — Medcura, Inc., a commercial-stage medical device company, announced today that it has moved into a new purpose-built facility in Riverdale, Maryland that will support the manufacture and commercialization of its growing product line.

Medcura chose the Discovery District, a growing center for technology and innovation, where high-tech companies can build businesses that develop, manufacture and commercialize disruptive new products. The Company worked with Terrapin Development and St. John Properties to design and deliver a facility that can house product development, manufacturing and leadership functions that will support commercialization of consumer, clinical, surgical and military applications of its proprietary platform. The Company intends to manufacture core cGMP compliant hemostatic and wound treatment materials at a scale necessary for commercial launch and in support of the clinical development of implantable devices.

Image: PRNewsfoto/Medcura, Inc.

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QIAGEN Launches Assay for Cancer Patients Following FDA’s Nod

QIAGEN N.V. QGEN announces the receipt of the FDA’s approval for its therascreen BRAF V600E RGQ polymerase chain reaction (“PCR”) Kit (therascreen BRAF V600E) as a companion diagnostic to the BRAF inhibitor, BRAFTOVI (encorafenib). The company also announced the subsequent launch of the kit. The FDA approved the use of the PCR kit as a companion diagnostic in combination with cetuximab to treat adult patients, who have metastatic colorectal cancer (“CRC”), with a BRAF V600E mutation after prior therapy. Notably, CRC patients having the mutation will be identified, using an FDA-approved test.

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Precigen Announces Clearance of IND to Initiate Phase I/II Study for First-in-Class PRGN-2009 AdenoVerse™ Immunotherapy to Treat HPV-positive (HPV+) Solid Tumors | BioSpace

GERMANTOWN, Md., April 20, 2020 /PRNewswire/ — Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase I/II trial for Precigen’s PRGN-2009, a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse™ platform designed to activate the immune system to recognize and target HPV+ solid tumors. HPV+ cancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer.

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LABORATORY SPACE Available in Rockville – MD

TENANT AMENITIES

  • Proximate to Rockville Metro Station and Rockville Town Square, which offers major amenities, including restaurants, retail, lodging, and banking
  • Access to Route 28, Route 355, I-270, and Route 200/ICC
  • Ample parking
  • Direct loading
  • Separate metering for utilities
  • Emergency generator
  • Zoned for Mixed-Use Business (MXB)

Click here for more information.

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GSK CEO: Coronavirus vaccine with Sanofi is ‘unprecedented collaboration’

GlaxoSmithKline CEO Emma Walmsley on Tuesday told CNBC’s Jim Cramer that her company’s newly announced partnership with industry peer Sanofi is an “unprecedented collaboration” between competitors.

The European pharmaceutical giants are combining their resources to develop a Covid-19 vaccine and aim to produce a batch within the next 20 months.

Image: https://www.cnbc.com

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Bayh-Dole 40 | Event (Thursday, April 23, 2020 – 12:30 PM TO 1:45 PM EDT)

The world is anxiously awaiting effective treatments for Covid-19, which is ravaging most countries. Fortunately, some of the best minds in our public and private sectors are putting everything they have into developing effective vaccines, drugs, and tests that are so desperately needed. Because of the Bayh-Dole Act, which allows academic institutions and federal laboratories to effectively license their discoveries so they can make the leap from being laboratory concepts into useful products, these partnerships are proceeding at full speed. Unfortunately, some want to undo this model at the very time we need it the most.

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EXCLUSIVE: AstraZeneca’s Calquence Shows Early Promise For COVID-19 Patients

British drug giant AstraZeneca is rushing forward a big clinical trial for its blood cancer drug Calquence because it has shown early promising results in later-stage COVID-19 patients—those in intensive care units and on ventilators. Calquence and top-selling leukemia drug Imbruvica are the latest hopes in getting coronavirus patients off ventilators, where there is a 50% mortality rate.

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Meet the Johns Hopkins team developing a 3D-printed device allowing COVID-19 patients to share ventilators – Technical.ly Baltimore

The COVID-19 crisis brought a shortage of ventilators that can help people battling the lung condition caused by the disease and led to a dire puzzle that leaders in the government and healthcare system are working to solve: how to acquire enough ventilators so that doctors don’t have to face the choice of refusing the machine to someone who needs it.

Image: The ventilator splitter prototype. (Photo courtesy of Johns Hopkins/Will Kirk)

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US Venture Capital Investment Has Strong Showing in Q1 2020, with Economic Downturn Brought on by COVID-19 Primed to Slow Activity | State | chinookobserver.com

SEATTLE, April 14, 2020 /PRNewswire/ — After elevated venture capital (VC) investment in the past few years, deal activity maintained momentum in the first quarter of 2020 amid the impending economic downturn due to the COVID-19 pandemic, which will slow activity through the rest of the year, according to the PitchBook-NVCA Venture Monitor, the authoritative quarterly report on venture capital activity in the entrepreneurial ecosystem jointly produced by PitchBook and the National Venture Capital Association (NVCA), with support from Silicon Valley Bank and Carta.

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Virginia Governor Orders Residents to Stay Home Until June 10

Virginia Governor Ralph Northam on Monday issued an order to residents stay at home until June 10, part of expanded efforts to curtail the coronavirus pandemic that continues to spread across the country.

“I want to be clear: Do not go out unless you need to go out. This is very different than wanting to go out,” the Democratic governor said in announcing the order.

Northam noted that “some of our beaches and other recreational areas were literally packed” over the weekend, and warned that, “everyone who is gathering in a crowd is putting themselves and others at risk.”

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Abbott Launches Third COVID-19 Test, a Laboratory-Based Antibody Blood Test That Will Ship in the U.S. Starting Tomorrow – Apr 15, 2020

ABBOTT PARK, Ill., April 15, 2020 /PRNewswire/ — Abbott (NYSE: ABT) announced today the launch of its third COVID-19 test, a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19). Antibody testing is an important next step to tell if someone has been previously infected. It will provide more understanding of the virus, including how long antibodies stay in the body and if they provide immunity. This type of knowledge could help support the development of treatments and vaccines.

This antibody test adds to Abbott’s existing COVID-19 tests that are already being used, including its m2000™ molecular laboratory system and its ID NOW™ molecular point-of-care device.

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HHS collaborates with non-government organizations to further COVID-19 immunotherapies – Homeland Preparedness News

The push for convalescent plasma and hyperimmune globulin immunotherapies to use against COVID-19 continues at the federal level, with the U.S. Department of Health and Human Services (HHS) touting collaboration with non-governmental entities to see it done.

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New Hopkins coronavirus maps looks at individual counties in US – Maryland Daily Record

Johns Hopkins University, whose global count of COVID-19 cases and deaths has become one of the most popular sources for information about the disease, has unveiled a new United States map that dives into the pandemic on a county level.

The U.S. map provides information about counties’ health infrastructure, population and policies and cases related to COVID-19, the disease caused by the coronavirus.

Image: Johns Hopkins University’s map tracking the COVID-19 has added county data, including snapshot infographics, like this one of Prince George’s County, for every county in the country. (Johns Hopkins University)

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Undetected COVID-19 Cases Counted by NIH

Current COVID-19 tests detect the presence of the SARS-CoV-2 viral RNA genome in patients’ samples through RT-PCR. They are designed to identify who has the virus in their system, at the time of testing. But, testing in the United States has been inadequate on multiple levels. There are not enough tests, leaving some patients waiting in long lines outside of the hospital and others sleeping overnight in their cars, waiting to be tested. Also, the tests’ levels of sensitivity (identifying those with the disease correctly) and specificity (identifying those without the disease) have been called into question.

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Vanquishing the Virus: 160+ COVID-19 Drug and Vaccine Candidates in Development

While President Trump continues to promote antimalarial drugs such as hydroxychloroquine sulfate and azithromycin to treat COVID-19—“What do you have to lose?” he exclaimed during the April 4 Coronavirus Task Force Briefing—the global community of drug discovery researchers and biopharmas is developing a much broader menu of therapeutic options.

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Blinking Red: 25 Missed Pandemic Warning Signs

“Nobody knew there’d be a pandemic” … “Nobody has ever seen anything like this before” … “Nobody would have ever thought a thing like this could have happened.”

Those were President Trump’s words in March about the COVID-19 pandemic. Trump’s repeated protestations were questioned by, among others, Trump himself, who told the White House press corps on March 17 that, “I felt it was a pandemic long before it was called a pandemic.”

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COVID-19: ‘Cough chamber’ shows six-feet not far enough – Neuroscience News

Summary: Droplets from a cough travel at a speed of 1.2 meters per second at peak velocity. Findings reveal that there is no logical reason to suggest 6 foot of physical distance is substantial at reducing coronavirus transmission.

Source: Western University

A recent Western-led study says two meters might not be far enough away if someone lets an uncovered cough loose in your direction – meaning sneeze and cough etiquette is more than a simple social nicety, but a key to stopping the spread of diseases like COVID-19.

Image: Western Engineering’s cough chamber is a two-metre enclosed cube with an opening and chin rest in the front, which is used as an access point for study participants to cough. Within the cube, a camera and a laser are used to determine the velocity of the expelled droplets from the cough. The image is credited to Frank Neufeld.

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Fed Steps Up to Provide More Help to Small and Mid-Sized Businesses, Including PPP Borrowers | Insights | Venable LLP

On Thursday morning, the Board of Governors of the Federal Reserve System (Board) released the highly anticipated details of its massive $600 billion Main Street Lending program (Program) to support small and mid-sized businesses with up to 10,000 employees. The Program is particularly welcomed by businesses that are too large to be eligible for loans under for the Paycheck Protection Program (PPP).

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Iceland’s Aggressive COVID-19 Testing Helped Curb Outbreak

Iceland has 364,000 inhabitants. Currently, roughly 10% of them are aware of whether or not they have COVID-19. This is due to a massive undertaking by Kári Stefánsson, MD, Dr. Med., the co-founder, president, and CEO of deCODE genetics—a population genetics powerhouse that has routinely produced new discoveries in fields such as genomic architecture, cancer genetics, and mental illness. Now, deCODE has combined the most intensive targeted testing and general screening of any population to date for SARS-CoV-2.

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GSK joins Sanofi effort to make coronavirus vaccine

Sanofi and GSK, two of the biggest names in vaccine development, are joining forces on creating a coronavirus vaccine, the companies announced Tuesday.

Sanofi launched the project in February; what’s new is GSK’s contribution of an adjuvant — a substance that is added to a vaccine to enhance people’s immune responses.

Image: JOSEPH N. DISTEFANO

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Home | About BHI | BHI News | Programs | Partners | Contact

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All Rights Reserved.



401st Edition – April 14, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


April 14, 2020












FOUNDING MEMBER OF



2020 BioHealth Capital Region Forum Planning Committee Update

We hope you and your families are well. This is a reminder that due to COVID19 the BioHealth Capital Region Forum, originally scheduled to take place this week, April 14th and 15th at AstraZeneca, has been postponed.

We are looking into combining the BioHealth Capital Region Forum with the BioHealth Capital Region Investment Conference which tentatively will be held between October 19th and 21st, 2020. We will advise you of our future direction on these events as soon as we develop our path forward. Please save these dates until we finalize the details as we hope to have an in-person event at that time. Thank you for your patience and understanding during these challenging times.

– BioHealth Capital Region Forum Planning Committee

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Montgomery County wants to spur medical manufacturing to fight coronavirus – Washington Business Journal

The coronavirus outbreak has required all manner of businesses and government agencies to turn on a dime and think creatively — and the Montgomery County Economic Development Corp. is no exception with its new effort to spur medical manufacturing.

In normal times, the EDC focuses primarily on attracting and retaining businesses in the Maryland suburb. But as a global pandemic roils the economy, many companies are simply struggling to survive, not eyeing new office space or a splashy relocation.

Image: Ben Wu, president and CEO of the Montgomery County Economic Development Corporation, is leading an effort to create a new “manufacturing ecosystem” for medical equipment in the county. EMAN MOHAMMED

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MARYLAND Business Relief Wizard

There are numerous local and national programs for businesses in need of emergency support, but understanding which options are relevant for your organization can be a challenge.

The Maryland Business Relief Wizard is a tool that helps connect businesses with the resources and programming for which they’re eligible, streamlining the process of finding support.

 

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Biotech Beach Emergent BioSolutions Aims to Fight COVID-19 | BioSpace

Biopharma companies are attacking the COVID-19 pandemic from many fronts. Emergent BioSolutions is among those leading the fight. The company has a proven track record, partners and extensive networks to advance vaccines or therapeutics quickly toward trials.

Emergent BioSolutions supplies the Strategic National Stockpile with vaccines against anthrax and smallpox, and treatments against anthrax, botulism and smallpox vaccine complications. Its pipeline includes vaccines against Chikungunya and anthrax (again), treatments targeting Zika and Influenza A, and now, COVID-19.

Image: https://www.biospace.com

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The COVID-19 vaccine development landscape

The genetic sequence of SARS-CoV-2, the coronavirus that causes COVID-19, was published on 11 January 2020, triggering intense global R&D activity to develop a vaccine against the disease. The scale of the humanitarian and economic impact of the COVID-19 pandemic is driving evaluation of next-generation vaccine technology platforms through novel paradigms to accelerate development, and the first COVID-19 vaccine candidate entered human clinical testing with unprecedented rapidity on 16 March 2020.

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Dr. Fauci: ‘We need to put our foot on the accelerator’ to see an end to COVID-19 pandemic | fox8.com

WASHINGTON (NEXSTAR) ─ Even though he says the worst is yet to come, Dr. Anthony Fauci, the nation’s top infectious-disease expert, has seen signs of progress in the country’s fight against the coronavirus.

“The next week we’re going to see a spike in deaths throughout the country, particularly in the hot spot areas like New York, but simultaneously with that, we’re starting to see some cautiously optimistic type signs,” Fauci said.

Image: https://fox8.com

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Daniels to Johns Hopkins community: ‘Our work continues’ | Hub

Johns Hopkins President Ronald J. Daniels shared a message with the university community today. The full text of the message is below.

Dear Johns Hopkins Faculty, Students, and Staff:

It has been a long and nerve-wracking month since we began to fully prepare for, and mitigate the impact of, the extraordinary challenges posed by COVID-19. Our colleagues from the Bloomberg School of Public Health remind us that we are still likely a few weeks from the peak of the pandemic in Maryland. For the foreseeable future, we will remain under significant strain as we respond in ways that run counter to our normal course of action and to our community’s innate desire to connect in person with each other.

Image: https://president.jhu.edu/

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emocha Expanding Remote Monitoring Service for COVID-19 Exposed Healthcare Professionals – emocha Mobile Health Inc.

In response to the COVID-19 crisis, emocha Mobile Health has implemented a remote monitoring service powered by human engagement to support health systems including Johns Hopkins Medicine and LifeBridge Health-affiliated hospitals. emocha uses short, asynchronous video check-ins to identify, track, and manage symptoms of healthcare professionals who have been exposed to COVID-19.

Healthcare workers are on the front lines of the COVID-19 (coronavirus) pandemic, and ensuring their safety and availability is critical. The virus is spreading rapidly across the globe with more than 35,350 confirmed cases in the United States as of March 23. As a result, this highly infectious and novel disease requires strategies to protect the public’s health and to slow the rate of transmission.

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PathSensors, Inc. Announced the Development of a SARS-CoV-2 Biosensor – PathSensors

BALTIMORE, MD March 24, 2020 – PathSensors Inc, a Baltimore biotechnology company, announced today that they are developing a CANARY ™ biosensor to detect the Novel SARS Coronavirus (SARS-CoV-2), the causal agent for the coronavirus disease COVID–19. The biosensor will be available for research purposes in May 2020 and validation data on the new SARS-CoV-2 product will be available June 2020.

CANARY ™ technology provides a unique opportunity to reduce the impending public health impact of COVID-19 with rapid results and high specificity. The initial application for this PathSensors product will be for testing of environmental swabs and air monitoring in sensitive spaces such as hospitals, offices, food services, etc. PathSensors will continue to advance the assay’s capabilities as the novel virus is further characterized. As the SARS-CoV-2 biosensor is commercialized, PathSensors expects new uses to emerge, such as rapid specimen screening.

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Aphena Pharma Solutions | Maryland Department of Commerce

BALTIMORE, MD (April 13, 2020) – Aphena Pharma Solutions, an industry leading organization that provides packaging and manufacturing solutions for the medical industry, is planning to expand its pharmaceutical manufacturing operations in the Town of Easton. The company, which currently operates within a 110,000 square foot facility at 7978 Industrial Park Road, is purchasing an additional 54,000 square foot facility adjacent to its existing location. Building renovations and the installation of new equipment is expected to begin this year, with an estimated completion time of December 2020. Aphena currently employs 150 full-time workers and plans to add an additional 100 jobs in Talbot County over the next two years.

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ITI Forms Collaboration with EpiVax & PharmaJet to Develop Novel Vaccine Candidate Against COVID-19 Using Its Investigational UNITE Platform – Immunomic Therapeutics

ROCKVILLE, Md. & PROVIDENCE, R.I. & GOLDEN, Colo.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it is developing a nucleic acid vaccine candidate against COVID-19 leveraging its investigational UNITE platform for prevention of the novel coronavirus disease caused by SARS-Cov-2 coronavirus. Immunomic will work with leaders from EpiVax and PharmaJet, who have a wealth of immunology and vaccine delivery expertise, to rapidly develop its COVID-19 vaccine. Immunomic’s UNITE platform has been widely applied to create vaccine candidates for rabies, yellow fever, dengue fever, hepatitis C and SARS, a relative to the SARS-Cov-2 coronavirus.

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Epidemic Modeling 102: All CoVID-19 models are wrong, but some are useful

This is the second post of the “Epidemic Modeling” series. We will be building up on our discussion from the first post, “Epidemic Modeling 101: Or why your CoVID-19 exponential fits are wrong”, so you might want to start reading there. You can find the notebooks I wrote to implement the models and generate the figures over at the GitHub repository I made specifically for this series:

Image: https://medium.com

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Children’s National Hospital Prepares to Admit Adults for First Time Due to Coronavirus | National News | US News

CHILDREN’S NATIONAL Hospital, one of the country’s leading pediatric medical centers, is prepared to accept adult patients after expanding its admission criteria for the first time in history to bolster the D.C. region’s hospital capacity during the coronavirus crisis.

In the event that regional hospitals see a surge of adult patients, Children’s National will accept patients under 30 years old who are showing respiratory symptoms and who may or may not have tested positive for COVID-19, a spokesperson tells U.S. News. The pediatric hospital, which opened in 1870, will also admit patients in their 20s with cancer or sickle cell disease if other area hospitals become concerned about capacity during a surge.

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Alexandria Real Estate Equities offering life science companies ‘Room to Grow’

Alexandria Real Estate Equities, Inc. (NYSE:ARE), an S&P 500® urban office REIT, is the first and longest-tenured owner, operator, and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, including Greater Boston, San Francisco, New York City, San Diego, Seattle, Maryland, and Research Triangle. Alexandria has a longstanding and proven track record of developing Class A properties clustered in life science, technology, and agtech campuses that provide our innovative tenants with highly dynamic and collaborative environments that enhance their ability to successfully recruit and retain world-class talent and inspire productivity, efficiency, creativity, and success. For more information, please visit www.are.com.

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How long do coronaviruses live on surfaces?

One of the most common questions that people search about hashtag#coronavirus is how long it lives on surface. Part of the hashtag#healthcommunication and hashtag#healthliteracy is presenting complicated information in different ways. Kudos to my WebMD colleagues for this inforgraphic

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David Rubenstein Interviews Economic Experts on COVID-19 – YouTube

The Economic Club of Washington, D.C. hosted its fifth virtual event on April 8, 2020. Club President David Rubenstein interviewed economic experts on the state of the economy and the financial forecast. In addition, they discussed the current U.S. and global economy, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the Federal Reserve’s response to the pandemic, and the way forward post COVID-19. Additionally, Dr. Kurt Newman provided a medical update on the evolving virus. The interview took place in three segments.

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3 lessons from Children’s National Hospital on rapidly setting up drive-thru COVID-19 testing | FierceHealthcare

Just as many schools around the nation began shuttering for the year last month due to the pandemic, top officials at Children’s National Hospital were quickly mounting their own response to address COVID-19 concerns among kids.

“We heard from our pediatricians in late February, early March that they were very worried about what they were seeing in the community,” said Children’s National Chief Operating Officer Kathleen Gorman during a virtual roundtable with FierceHealthcare this week.

Image: Here’s a look at the advice Children’s National had to offer other hospitals about lessons learned from standing up a drive-thru specimen collection site within one week. (Children’s National Health System)

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Women’s Venture Competition – AIM-HI

The AIM-HI Accelerator Fund’s Women’s Venture Competition is a high-profile initiative among women-led oncology start-up companies or venture teams aspiring to soon establish such firms, in which all participants are offered access to intensive accelerator boot-camp programming by one of the world’s most renowned women entrepreneur accelerator and business training service providers, Springboard Enterprises, and—subject to due diligence and negotiation—the winning business will receive up to $300,000 in AIM-HI investment.

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Pediatric Medical Device Pitch Competition Pivots to Virtual Format Amid COVID-19 Crisis · BioBuzz

COVID-19 wasn’t about to stop the important work being done to meet the large unmet need for pediatric medical devices among patients younger than 18. NCC-PDI’s annual “Make Your Medical Device Pitch for Kids!” pitch competition moved to a 100% virtual event format to keep pediatric medical device innovation moving forward while complying with social distancing recommendations that will help to flatten the curve.

In late March, 30 outstanding companies pitched their pediatric device innovations in cardiovascular, orthopedic, spine and Neonatal Intensive Care Unit (NICU) devices — areas where the need is greatest — to judges in a virtual meeting room setting.

Image: https://biobuzz.io

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Will JPM21 be safe to attend? Plus: Layoffs at Sage and a deal brokered over Zoom

Just three months ago, thousands of biotech types blotted out the streets of San Francisco for the J.P. Morgan Healthcare Conference, four days of crowded rooms, overstuffed bars, and double-booked meetings. Today, with the coronavirus forcing the industry to interact via videoconference, that kind of physical proximity is difficult to imagine. And it might still be unsafe by the time JPM 2021 rolls around.

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The DMV region’s life sciences sector jumped into the fight against COVID-19. Here’s why it could move quickly – Technical.ly Baltimore

A new coronavirus was spreading in the U.S., and with social distancing orders going into place, talk immediately turned to finding a treatment that could stop the spread. In Maryland, companies jumped into action. Work began on a vaccine at Gaithersburg-based Novavax, and the company partnered with Emergent Biosolutions on initial development and manufacturing. Gaithersburg’s Altimmune is also developing a vaccine, and announced plans last week for a preclinical testing collaboration with the University of Alabama Birmingham.

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MD National Capital Region Economic Development Alliance Press Release — MCEDC

Rockville, Md. — In a greater effort to ensure that the Maryland National Capital Region can emerge as quickly as possible from the expected economic hardships of the COVID-19 coronavirus, the Montgomery County Economic Development Corporation (MCEDC) announced today that it has joined with its state peers in the Greater Washington metropolitan area to form a regional alliance to support an economic recovery.

A Joint Statement of collaboration formalizing the Maryland National Capital Region Economic Development Alliance (MNCREDA) was signed virtually by the leaders of the economic development organizations representing six counties. The Joint Statement document and a photo of its virtual signing are attached.

Image: https://thinkmoco.com

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Coronavirus updates: Nursing homes surge in deaths, Italy daily death toll

Nobel-prize winning economist Robert Shiller warns a pandemic of fear could tip the economy into an undeserved depression.

Shiller, an expert in how our emotions drive financial decisions, finds the sheer volume of chatter surrounding depression risks due to the coronavirus could severely hurt the economy.

Image: https://www.cnbc.com

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These 8 maps show the massive drop in smog caused by the coronavirus

As streets have emptied of traffic during the coronavirus crisis and airlines have cut flights, the changes have temporarily helped another public health crisis—air pollution. In the Northeastern U.S., nitrogen dioxide pollution (the air pollution caused by internal combustion engines burning fossil fuels) fell 30% in March as lockdowns began. Los Angeles’s usual smog has nearly disappeared. The same pattern happened earlier in China and Italy as mobility slowed, factories shut down, and hazy skies cleared.

Image: These maps show the air pollution levels in late March 2019 and the late March 2020. Map: courtesy Descartes Labs

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The 6-feet office is designed for work after COVID-19

It’s hard to imagine now—as most of us are reading this in quarantine, with our feet propped on Costco boxes of spaghetti noodles—but we will one day have to go back to our offices. COVID-19 won’t be eradicated, and not everyone will be immune. But we’ll still be expected to sit at a desk and work. So how will work…work?

Image: courtesy Cushman & Wakefield

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‘We need an army’: Hiring of coronavirus trackers is likely set to soar

K.J. Seung is surprised to be hiring and training new workers in Boston.

His public health nonprofit, Partners in Health, specializes in helping the poorest people in developing nations — tracking down contacts of Ebola patients in Liberia and Sierra Leone; running child health and HIV clinics in Haiti; and operating tuberculosis control programs in Peru. But now it is advertising for 500 people to help do what’s known as contact tracing to try to control Covid-19 in Massachusetts.

Image: Riders on the New York City subway last week wear personal protective equipment. JOHN MINCHILLO/AP

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The “Newest Normal”​: The Six Pivots for Economic, Skills, Investment-Resilient Strategies | LinkedIn

First went the energy sector, second the stock-market, then the health-pandemic outbreak, soon flood and storm season return. These persistent shock waves of challenges and disasters do not allow for economies, companies, institutions nor individuals to absorb much less pause operationally, financially, nor emotionally. The “New Normal” is survival – not of the fittest but of those able to pivot their strategies and visions the fastest. Here are six economic, skill, and investment resilient strategies for the 21st Century Pivot. (And yes, you and your team have little time to conduct the typical whiteboard session, report preparation, spreadsheet development because The Pivot is now!)

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VA 30 Day Fund – Home

The COVID-19 crisis has put millions of small business jobs at risk. These small businesses are experiencing a near-fatal cash crunch as they struggle to keep their doors open and jobs intact. These next few critical weeks will impact millions of jobs.

The non-profit Virginia 30 Day Fund provides forgivable loans for Virginia-based small businesses. The forgivable loan is intended to provide immediate financial assistance (within maximum three days) to meet payroll, preserve healthcare coverage for employees and save jobs while they await recently approved federal funding.

The Virginia 30 Day Fund is designed to be quick, easy, and free of red tape, as small business owners work to keep employees on board in the near term. All we ask in return: if you can, pay it forward.

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Danaher raises $825M to pay down debts, days after closing acquisition of GE’s biopharma business – Washington Business Journal

Danaher Corp. (NYSE: DHR), the massive D.C. conglomerate of industrial and commercial manufacturers, said Wednesday it has raised $753.7 million euros, or the equivalent of $825.3 million, through the issuance of new shares and will use proceeds to pay off debts, according to a Securities and Exchange commission filing.

The raise was disclosed just days after Danaher finally closed its $21.4 billion acquisition of the biopharma business of General Electric Co.’s life sciences division. Danaher announced its intent to purchase the business in February 2019, and the deal necessitated regulatory approvals in several countries and a substantial stock sale to finance the acquisition.

Image: Danaher Corp. closed its $21.4 billion acquisition of GE’s biopharma business March 31. IGOR GOLOVNIOV

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NIH begins study to quantify undetected cases of coronavirus infection | National Institutes of Health (NIH)

A new study has begun recruiting at the National Institutes of Health in Bethesda, Maryland, to determine how many adults in the United States without a confirmed history of infection with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), have antibodies to the virus. The presence of antibodies in the blood indicates a prior infection. In this “serosurvey,” researchers will collect and analyze blood samples from as many as 10,000 volunteers to provide critical data for epidemiological models. The results will help illuminate the extent to which the novel coronavirus has spread undetected in the United States and provide insights into which communities and populations are most affected.

Image: Colorized scanning electron micrograph of an apoptotic cell (blue) infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. NIAID

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6 Ways To Doom Your Startup Despite A Great Solution – Startup Professionals Musings

As an entrepreneur mentor and startup investor, I see with sadness the 50 to 90 percent that fail. If you ask them for a reason, most will insist that they couldn’t get funding, or they ran out of money too early. But I’m not convinced that it’s as simple as that. Many are just not facing the reality that their passion had a critical business flaw.

Image: https://blog.startupprofessionals.com

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8 Tips for Running a Startup Like a True Leader

Everybody thinks they’re a leader, but most are far from it. Successful startups, at all levels, depend on leadership and the ability of a few to organize both day-to-day and long-term goals. On the face of it, this sounds simple, but the reality is that not everyone is cut out to lead and to run a successful startup. It requires a certain mindset and armory of skills. These eight tips can help you lead your team.

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Good Time to Invest in Health Care in China: Qiming Venture Partners – Bloomberg

Gary Rieschel, founding managing partner at Qiming Venture Partners, one of China’s most prominent venture capital firms, discusses the opportunities he sees in the market. Qiming has closed a new $1.1 billion fund, even as uncertainties around Covid-19 depress startup funding. Rieschel speaks with Selina Wang and Rishaad Salamat on “Bloomberg Markets: China Open.” (Source: Bloomberg)

Image: https://www.bloomberg.com

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We Need Imagination Now More Than Ever

The idea of “crisis management” requires no explanation right now. Something unexpected and significant happens, and our first instincts are to defend against — and later to understand and manage — the disturbance to the status quo. The crisis is an unpredictable enemy to be tamed for the purpose of restoring normality.

But we may not be able to return to our familiar pre-crisis reality. Pandemics, wars, and other social crises often create new attitudes, needs, and behaviors, which need to be managed. We believe imagination — the capacity to create, evolve, and exploit mental models of things or situations that don’t yet exist — is the crucial factor in seizing and creating new opportunities, and finding new paths to growth.

Image: Illustration by Kirsten Ulve

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We should stop categorizing careers as academic vs. nonacademic (opinion)

About a year ago, I made a career transition into professional and academic development support for graduate students and postdoctoral scholars. I have found the work immensely fulfilling, and as with any other new position, I spent quite a bit of time in my first several months trying to catch myself up to speed on the lingo of the profession.

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400th Edition – April 7, 2020

By BHI Weekly Newsletter Archives

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April 7, 2020

FOUNDING MEMBER OF

 

 

BHI and DLA Piper Host Webinar on Navigating the CARES Act for Life Sciences Companies in the BioHealth Capital Region
 

On April 3rd, 2020, DLA Piper and BioHealth Innovation, Inc. (BHI) presented an overview of the key provisions for BioHealth Capital Region Life Sciences companies in the $2 trillion Coronavirus Aid, Relief, and Economic Security Act stimulus package via webinar.

The hour-long review and discussion was recorded and is NOW AVAILABLE to access online.

 

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BioHealth Innovation Appoints Rebecca Farkas, PhD and Sara Nayeem, M.D. to Board of Directors
 

New Members Continue GSK and NEA’s commitment to the BHI mission and the BioHealth Capital Region

ROCKVILLE, MARYLAND, April 6, 2020 The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointments of two new board members, Rebecca Farkas, PhD, Director, External R&D, Scientific Collaborations at GSK, and Sara Nayeem, M.D., Partner at New Enterprise Associates (NEA). BHI’s leadership also thanked outgoing Board of Directors members Rip Ballou of GSK and David Mott of NEA for their contributions to the organization and friendship of many years.

 “I am honored to welcome both Rebecca and Sara to our Board of Directors,” said Richard Bendis, BHI President and CEO. “They both bring a combination of experience and fresh vision to our already robust collection of industry leaders. We are excited to to work with them to help grow the BioHealth Capital Region industry cluster.”

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Emergent BioSolutions Executive Vice President, Manufacturing and Technical Operations, Sean Kirk Guests on BioTalk
 

Sean M. Kirk, Executive Vice President, Manufacturing and Technical Operations at Emergent BioSolutions joins Rich Bendis to discuss the COVID-19 Health Crisis, Emergent’s Capabilities in Manufacturing in the BioHealth Capital Region and Beyond

Mr. Kirk joined Emergent BioSolutions in 2003 and has served as executive vice president, manufacturing and technical operations since April 2019. Prior to this position, Mr. Kirk has held various senior leadership roles including senior vice president, manufacturing operations and contract development and manufacturing operations (CDMO) business unit lead from April 2017 to March 2019, senior vice president, biodefense operations from November 2015 to March 2017, senior vice president, biosciences operations from February 2014 to November 2015 and senior vice president, biodefense vaccines and therapeutics development from March 2012 to February 2014. Mr. Kirk also served in multiple roles of increasing responsibility at Emergent’s manufacturing operations site in Lansing, Michigan.

Before joining Emergent, Mr. Kirk worked at Merial, a multinational animal health company, serving in various positions from 1996 to 2001. Mr. Kirk received both an M.B.A. and B.S. in Microbiology from the University of Georgia.

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BioHealth Innovation Entrepreneur-in-Residence Feedback (April 22nd)
 

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs through video conference on one of the following dates: 4/22, 5/20. (45 minute blocks of time beginning at 9:00 in the morning.)

Pre-registration is required; sign up here:

For questions/more information, contact BHI.

 

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Immunomic Therapeutics builds coronavirus vaccine, plots IPO – Washington Business Journal
 

Immunomic Therapeutics Inc. is pivoting, as many are, in this new era to work on a vaccine for the novel coronavirus. But it’s also pursuing goals that would be considered ambitious even before the world changed: It’s closing in on a $50 million raise, advancing its brain cancer program — and positioning itself for an initial public offering.

The Rockville vaccine maker secured the first $10 million of this latest fundraising round at the end of January from Korean investment group HLB, and it expects to close on another $40 million-plus in the next couple of weeks, said Bill Hearl, founder and CEO of ITI. That capital would support the immuno-oncology company’s therapy for glioblastoma, an aggressive brain cancer, now heading into a phase 2 clinical trial after a successful phase 1 study that extended the typical 14- to 16-month median survival rate to 41 months.

Image: Bill Hearl is CEO and founder of Immunomic Therapeutics in Rockville. COURTESY IMMUNOMIC THERAPEUTICS

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BioHealth Capital Region COVID-19 Resources
 

 

BioHealth Capital Region COVID19 Resources:

In these uncertain times, we are proud to have so many BioHealth Capital Region federal, state, local and private sector organizations focused on combatting COVID19.  Please use these links to stay abreast of the last news and resources available for your business.

District of Columbia 

Maryland

Montgomery County, MD

Virginia

US Small Business Administration 

Volunteers

 

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URGENT: Providers Needed | COVID-19, Maryland
 

Like many states across the nation, Maryland is preparing for a possible surge of COVID-19 patients.  Johns Hopkins is working with the state and the University of Maryland to erect an Alternate Care Site at the Baltimore Convention Center (ACS BCC). The ACS BCC is planned to open by mid-April and is intended to be used as a post-acute treatment facility.

Johns Hopkins is working on the recruitment, contracting, and credentialing of temporary Physicians and Advanced Practitioners. Compensation will be provided. We are reaching out to you, as a leader within your organization, in hopes that you might forward this to interested parties who may be willing to temporarily assist in treating patients recovering from COVID-19. Please see the attached job posting for details.

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Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding | grants.nih.gov
 

The NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. Due to the potential exceptional impact, we want to assure our recipient community that NIH will be doing our part to help you continue your research.

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You’ve Never Heard of BARDA, the Agency That May Rescue You From Coronavirus
 

One of America’s biggest companies has teamed up with one of the country’s least-known federal agencies to make doses of a coronavirus vaccine. Lots of them.

The deal underscores the important role that the U.S. Biomedical Advanced Research and Development Authority, or BARDA, plays behind the scenes in protecting Americans—and everyone, really—from pandemics.

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Emergent BioSolutions gets $14.5M in federal funding to expedite COVID-19 plasma therapy development | TechCrunch
 

Last week, we spoke to the head of Emergent BioSolutions’ Therapeutics Business Unit Dr. Laura Saward about her company’s work developing plasma-based potential treatments for COVID-19. Now, the company announced that it has received $14.5 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services (HHS), to speed the development of one of its treatment candidates.

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Johns Hopkins gets FDA approval to test blood plasma therapy to treat COVID-19 patients | Hub
 

The U.S. Food and Drug Administration approved a clinical trial Friday that will allow Johns Hopkins University researchers to test a therapy for COVID-19 that uses plasma from recovering patients.

Arturo Casadevall, a Johns Hopkins infectious disease expert, proposed the use of convalescent plasma to treat critically ill COVID-19 patients and to boost the immune systems of health care providers and first responders. He assembled a team of physicians and scientists from around the United States to establish a network of hospitals and blood banks that can collect, isolate, and process blood plasma from COVID-19 survivors

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QIAGEN Receives US FDA EUA for First and Only Syndromic Coronavirus Test – COVID-19 – Hospimedica.com
 

QIAGEN (Hilden, Germany) has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus. The EUA approval status comes after QIAGEN recently began shipping QIAstat-Dx SARS-CoV-2 test kits to the US under a new FDA Policy allowing the kits to be made commercially available.

Image: QIAstat-Dx Respiratory SARS-CoV-2 Panel test (Photo courtesy of QIAGEN)

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How to Obtain an SBA Coronavirus PPP Loan and Have It Forgiven
 

The number-one pressure on small-business owners right now is payroll. Whether you’re a sole proprietor one-person-show or a company with 500 employees, you’ve certainly felt the pressure. Maybe you’ve already stopped paying yourself, have laid off workers or cut hours. Well, you can thank your federal government for the best aid program recently offered for small business, the Paycheck Protection Program loan (aka Coronavirus Stimulus Loan, or PPP Loan).

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GSK, AstraZeneca in talks for joint U.K. COVID-19 diagnostics project: Bloomberg | FierceBiotech
 

GlaxoSmithKline and AstraZeneca are considering forming a joint laboratory to help the U.K. government stretch and expand its supplies for COVID-19 diagnostic tests, according to a report from Bloomberg.

Even though diagnostics are not their core efforts, the plan is for the two Big Pharmas to test a range of different reagents, chemical mixtures and other materials for new ways to help detect the spreading novel coronavirus. Successes would be provided to other manufacturers or the U.K.’s National Health Service.

Image: Global supplies of testing reagents and other materials, including swabs, have been faced with overwhelming demand in recent weeks. (NIAID – Rocky Mountain Laboratories)

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When working remotely, constant communication is key to more action – Washington Business Journal
 

Not long ago, working from home was an option for some of us.

Today, it’s the norm for nearly all of us.

Unless your job absolutely requires you to be on the front lines, the coronavirus pandemic has caused us all to set up home offices and social distance ourselves from coworkers and clients alike.

That shift has likely carried some stumbling blocks, something even the most seasoned remote worker can attest to.

Image: https://www.bizjournals.com

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Potential COVID-19 Treatments and Vaccines in Research Pipeline
 

We’re currently tracking 95 potential treatments and 52 potential vaccines in the pipeline to combat hashtag#COVID19.

There are thousands of researchers all over the world racing to get a treatment or vaccine to market.

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Three Long-Time Emmes Employees Are Named VPs
 

ROCKVILLE, Md., April 6, 2020 /PRNewswire/ — Emmes today announced that Heather Hill, Dr. Adam Mendizabal and Dr. Nilay Shah have been promoted to vice president. According to Dr. Anne Lindblad, president and chief executive officer, “These promotions reflect their talent and value to the organization. Heather, Adam and Nilay demonstrate our commitment to developing staff and promoting from within. They will strengthen and add great value to our leadership team and will support our plans to grow both internally and externally.”

Heather Hill

Dr. Adam Mendizabal

Dr. Nilay Shah

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Washington Business Journal’s Sara Gilgore to anchor DC Inno
 

A few weeks ago, I was in New Orleans for a jam-packed wedding weekend, complete with a crawfish boil, second line parade, Hawaii-themed 30th birthday luau for the bride-to-be, and more gumbo and jambalaya than we could eat (and guys, we’re talking authentic Louisiana Creole, which was just delicious.)

Image: Image via the Business Journals

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Accelerator Series / Maryland SBDC
 

COVID-19 Notice for Maryland SBDC Clients, Stakeholders, and Partners

We are committed to serving our clients during the COVID-19 (Coronavirus) health emergency.

Consulting Services – New clients already in business can request COVID consulting assistance by clicking on the “I’M IN BUSINESS- GET CONSULTING” on our home page. The link is right below this notice towards the right side of the page. Continuing clients may continue to contact their consultant by phone, web conference, or email.

Training – All in-person training scheduled during the month of April has been canceled, postponed or offered online. If a paid training class is canceled or postponed, participants may request a refund or apply the funds to another class. If the class will be offered online, registered participants will receive an email with instructions for participating in the online class.

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Emergency Assistance Package for Covid-19
 

Information regarding the hashtag#montgomerycountymd Public Health Emergency Grant Program passed by County Council yesterday. The County Executive’s staff is preparing regulations and plans to implement the program as quickly as possible. Businesses may submit questions about the program to: BizinfoCovid19@montgomerycountymd.gov. More info to come! hashtag#covid19response hashtag#moco

Image: https://www.linkedin.com

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SBA loans: Answers on interest rates, application process and CARES Act from Mid-Atlantic boss – Philadelphia Business Journal
 

Steve Bulger has heard all the complaints.

The acting director for the U.S. Small Business Administration’s Mid-Atlantic region knows about the technical issues that applicants for the agency’s Economic Injury Disaster Loans (EIDL) faced last week.

He’s received questions about why those loans come with interest rates well above the Federal Reserve’s current standard rate.

Image: Steve Bulger, acting director for the U.S. Small Business Administration’s Mid-Atlantic region, has been dealing with an overflow of loan applications from small businesses struggling amid the COVID-19 crisis. U.S. SMALL BUSINESS ADMINISTRATION

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FDA launches push to speed up Covid-19 drug development efforts – MedCity News
 

The agency said it had redeployed some staff and streamlined processes to enable it to review clinical trial protocols faster and respond faster to companies and scientists developing new drugs for the disease.

The Food and Drug Administration hopes to expedite development of treatments for Covid-19 under a new program that the agency announced Tuesday.

The FDA said that under the Coronavirus Treatment Acceleration Program, or CTAP, it is redeploying staff and streamlining processes with the goal of speeding up reviews of clinical trial protocols and single-patient expanded-access requests.

Image: https://medcitynews.com

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Sagamore Spirit and Johns Hopkins collaborate to make hand sanitizer | Hub
 

In the middle of a hand-sanitizer shortage caused by the coronavirus pandemic, Johns Hopkins and Baltimore distillery Sagamore Spirit are working together to manufacture the disinfectant for use by the Johns Hopkins Health System.

The collaboration came together in less than 10 days, with Sagamore Spirit converting 100% of its distillation processes from rye whiskey mash bills to corn ethanol in support of the effort.

Image: IMAGE CREDIT: WILL KIRK / JOHNS HOPKINS UNIVERSITY

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7 BioHealth Capital Region Diagnostics Companies Leading the Fight Against COVID-19 · BioBuzz
 

Prominent research universities and government agencies are keeping the public abreast of the scope of the coronavirus pandemic as well as the reported outcomes of identified cases.

Major media outlets are doing their best to share information in real-time, but often portray spiking case numbers in hotspots like New York City as the accelerating spread of COVID-19. The reality, in many states across the U.S., is that COVID-19 has already infected large swaths of the population, so the coronavirus is not necessarily “spiking” but rather being revealed through better diagnostics and wider access to COVID-19 testing.

Image: https://biobuzz.io

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COVID-19 Tip Sheet: Story Ideas from Johns Hopkins
 

Newswise — When T.C. Wu, M.D., Ph.D., M.P.H., and Chien-Fu Hung, Ph.D., heard earlier this year about a new coronavirus that was spreading in China, their pathology labs immediately started developing a vaccine. That’s because nearly 20 years ago, Wu and Hung worked on a vaccine for another coronavirus that originated in China — severe acute respiratory syndrome, or SARS. So far, Wu and Hung have observed that the new coronavirus is “smarter” and “sneakier” than SARS, and they are concerned it will not go away like SARS did. Wu and Hung can discuss how their lab administered the new coronavirus vaccine to mice, and that preliminary results should be back by the end of the month. Watch this video and read this story about their efforts.

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Anthony Fauci Shows Us the Right Way to Be an Expert – Scientific American Blog Network
 

Anthony Fauci has been an extraordinary presence during the COVID-19 crisis: calm yet urgent, informative yet plain-spoken. Along the way, he’s doing something even more difficult than explaining COVID-19. He’s providing insight about the role of the scientific expert in a liberal democracy.

Image: https://en.wikipedia.org/wiki/Anthony_Fauci

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Children’s National Hospital coronavirus testing kids | wusa9.com
 

WASHINGTON — Nearly 300 children have now been tested in the District’s first drive-thru COVID-19 coronavirus test site, with no kids in the nation’s capital needing life-saving ventilators as the virus wreaks havoc on older populations.

But after the first American infant died of coronavirus in Chicago on Saturday, a new focus on testing children has entered the national conversation – with treatment for the youngest coronavirus patients potentially playing a key role in fighting the outbreak.

Image: https://www.wusa9.com

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How Biotech Player You Haven’t Heard of Is Racing Gilead, Moderna to Coronavirus Treatment – TheStreet
 

Emergent BioSolutions (EBS) – Get Report may be a small company up against the heavy hitters, but it has a plan for a coronavirus treatment, one indication that many players are taking their shot at a vaccine, as the world eagerly waits a solution.

Monday, Johnson & Johnson (JNJ) – Get Report said it will start human testing of a vaccine for the Coronavirus as early as September. The company joins Gilead Sciences (GILD) – Get Report, which the World Health Organization says is a front-runner in making a viable drug, in finding a solution to Covid-19.

Image: https://www.thestreet.com

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Amid concerns that startups could be left out of COVID-19 bailout, investors step up lobbying | TechCrunch
 

The massive bailout package that the U.S. government passed last week to stave off an economic collapse from measures put in place to mitigate the spread of the COVID-19 epidemic is giving out billions to American small businesses. But startups that received venture capital money could be left out.

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Emergent BioSolutions Partners with U.S. Government for Comprehensive Response to Expedite Development of Plasma-Derived Therapy for COVID-19 NYSE:EBS
 

GAITHERSBURG, Md., April 02, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into a formal partnership with the U.S. government to expedite development of a plasma-derived therapy for patients with coronavirus disease 2019 (COVID-19). Emergent has received $14.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS), in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March.

COVID-HIG is a candidate human hyperimmune product being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.

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Emergent BioSolutions Signs Agreement with Novavax to Manufacture NanoFlu™
 

GAITHERSBURG, Md., March 31, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (EBS) today announced an agreement with Novavax, Inc. (NVAX) whereby Emergent will provide molecule-to-market contract development and manufacturing (CDMO) services to produce Novavax’s NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant. Novavax recently announced that NanoFlu met all primary objectives in its Phase 3 clinical trial evaluating immunogenicity and safety in adults aged 65 and older.

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Coronavirus Patients May Carry Virus for a Week after Symptoms Have Resolved
 

A small study reported by researchers in Beijing and the United States found that 50% of patients treated for COVID-19 infection still carried the virus for up to eight days after their symptoms had disappeared. The authors, reporting their results in American Journal of Respiratory and Critical Care Medicine, say they don’t yet know whether the virus might still be capable of transmission at the late stages of disease. However, the results indicate that quarantine periods might need to be lengthened in some recovered patients.

Image: NIAID

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venBio Closes $394 Million Life Sciences Venture Capital Fund | BioSpace
 

SAN FRANCISCO–(BUSINESS WIRE)– venBio Partners LLC today announced the closing of venBio Global Strategic Fund III (“venBio Fund III”), its third life sciences venture capital fund, exceeding its target and closing on approximately $394 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising pharmaceutical companies, corporate pensions, financial institutions, endowments and foundations, family offices and funds-of-funds.

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Emergent Announces Partnership with the U.S. Government
 

We’re proud to announce a partnership with the U.S. Government on a comprehensive response to expedite development of our plasma-derived therapy to address hashtag#COVID19. https://lnkd.in/eHGC5F6

hashtag#toprotectandenhance hashtag#emergentbiosolutions hashtag#COVID19 hashtag#coronavirus

Image: https://www.linkedin.com

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Solicitations | SBIR.gov
 

Solicitations play an important role in making the general public aware of funding opportunities available to the small businesses of the nation. Participating Federal Agencies post these funding opportunities on a regular periodic basis throughout the year associated to SBIR/STTR.

To become involved with the Small Business Innovation Research (SBIR) or the Small Business Technology Transfer (STTR) program, small businesses can compete by submitting solicited proposals to these agencies. A winner in the competitive solicitation process is awarded a grant or contract. The SBIR/STTR program does not fund unsolicited proposals (proposals that do not refer to and address a specific topic in a current agency SBIR/STTR solicitation).

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398th Edition – March 24, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


March 24, 2020












FOUNDING MEMBER OF



BioHealth Capital Region Resources for Businesses Impacted by COVID-19

Here are some resources you might find useful if you’re impacted by COVID-19

Volunteers

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Urgent Need for Healthcare Workers

As our community responds to COVID-19, Adventist HealthCare hospitals are caring for those most impacted by the virus in our community. Their need for health care professionals will grow more urgent as the number of local cases increase. As part of its preparedness planning, Adventist HealthCare is asking the research community to help. They are looking for physicians, nurses or technicians who could assist with testing, registration and patient care. If you would be willing to serve Adventist HealthCare during this unprecedented time, please contact Yasmin Nasser at (ynasser@adventisthealthcare.com/301-315-3220) to be added to a list of reserve employees. Whether you are social distancing and practicing good hygiene, or choose to serve in a more direct way, we applaud everyone’s efforts to stop the spread of COVID-19 in our community.

 

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BHI portfolio company MockV Solutions led by David Cetlin acquired by Maravai LifeSciences

SAN DIEGO (March 17, 2020) – Maravai LifeSciences, a global provider of life science reagents and services to researchers and biotech partners, announced today that it has acquired MockV Solutions. MockV plays an important role in helping biopharma customers develop manufacturing processes that are free of viral contamination, leading to the production of safe biotherapeutics. The MockV acquisition, coupled with Maravai’s previous acquisition of Cygnus Technologies, expands Maravai’s leadership position in bioprocess impurity testing. Impurity testing is a critical step in the development and manufacture of biotherapeutic products.

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QIAGEN dramatically ramping up global production capacity for RNA extraction kits for use in detection of SARS-CoV-2 coronavirus

Hilden, Germany, and Germantown, Maryland, March 17, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced plans to dramatically ramp up global production capacity of RNA extraction kits that are used as part of workflows around the world to detect nucleic acid from SARS-CoV-2, the novel coronavirus that causes COVID-19.

QIAGEN has historically allocated global production capacity to manufacture RNA nucleic extraction reagents to supply about 1.5 million patient tests on a monthly basis. Now QIAGEN is ramping up production capacity for these reagents to support a level of more than 6.5 million patient tests a month by the end of April 2020 and over 10 million patient tests a month by the end of June 2020. A significant capacity expansion project is underway at sites in Europe and the United States to reach more than 20 million patient tests on a monthly basis by the end of 2020 to support the response to this global public health crisis.

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For Maryland, medical worker shortage may be top concern as coronavirus spreads | WTOP

There have been concerns about possible shortages of hospital beds and protective gear during the COVID-19 pandemic, but the biggest concern in Maryland may be not having enough medical workers.

“Staffing might be more of a constraint than beds and supportive equipment,” said Bob Atlas, president and CEO of the Maryland Hospital Association. The group represents all of the state’s hospitals.

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Emergent Biosolutions will manufacture Vaxart’s experimental coronavirus vaccine in Baltimore – Technical.ly Baltimore

Gaithersburg-based Emergent Biosolutions on Wednesday said it signed a second agreement in a week that will bring manufacturing of a coronavirus vaccine candidate to Baltimore.

The new agreement is with Vaxart, a San Francisco-based biotechnology company that is developing an experimental oral vaccine candidate that would be administered by tablet.

Image: https://technical.ly – Courtesy photo

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COVID-19 Resources for Applicants and Recipients of NIH Funding | NIH Extramural Nexus

The NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. This is a rapidly evolving situation, and we are aware that many institutions are taking a variety of “social distancing” measures, including switching to telework and cancelling or postponing classes and non-essential meetings.

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In Conversation: Sean Kirk, Emergent BioSolutions · BioBuzz

Following up on the recent article Two Maryland Biotechs Partner to Bring Coronavirus/COVID-19 Vaccine Candidate into Clinical Trials, BioBuzz had the opportunity to speak with Emergent BioSolutions Executive Vice President, Manufacturing and Technical Operations, Sean Kirk.

Let’s start by having you provide a brief background on your role at Emergent.

I have been with the company for nearly 17 years, and have had the good fortune of working in and being responsible for many key parts of the business including manufacturing operations, quality assurance, regulatory affairs, product development, U.S. government program management, global operational excellence, global supply chain, medical and clinical affairs. In these roles I have spent a lot of time across Emergent’s sites and have been based in Lansing, Mich. – where I started – Gaithersburg, Md, and Winnipeg, Manitoba.

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Emergent BioSolutions Signs Development and Manufacturing Agreement with Vaxart for their Experimental Oral Vaccine Candidate for Coronavirus Disease – BioHealth Capital Region

GAITHERSBURG, Md., March 18, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company, whereby Emergent has agreed to utilize its molecule-to-market contract development and manufacturing (CDMO) services to develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Development services will begin immediately, and upon Vaxart’s election, Emergent agrees to produce clinical material expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform.

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Critical Conversations with Rich Bendis

Rich speaks with VIVA Creative • Business Development & Strategic Partnerships. Image:

http://vivacreative.vzaar.me – From Video

http://vivacreative.vzaar.me/21376036

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Maryland company swamped with applicants to help assemble coronavirus test kits | wusa9.com

GERMANTOWN, Md. — German company Qiagen is racing to assemble new COVID-19 test kits. Already approved for use in Europe, Qiagen’s new kits are now getting assembled in their North American headquarters in Germantown, Maryland.

Image: Qiagen’s North American headquarters in Germantown, Maryland Nathan Baca

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Catching Up to Coronavirus: Top 60 Treatments in Development

Anthony Fauci, MD, Director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), offered hope to the thousands of people with confirmed cases of COVID-19, and the millions around the world whose lives have been disrupted by the pandemic caused by SARS-CoV-2, when he expressed to a congressional panel last week his hope that the first patients would be dosed with vaccines in development for the novel coronavirus “in a few weeks.”

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Md. biotech companies are working on new COVID-19 vaccines, tests – Baltimore Business Journal

Novavax and Emergent Biosolutions are not the only Maryland companies developing COVID-19 countermeasures. More than 15 local companies will meet virtually Friday to share their efforts.

Image: Maryland biotechs are coming together to build vaccines and diagnostic tests for COVID-19. CENTERS FOR DISEASE CONTROL AND PREVENTION

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Pathogen-testing company Aperiomics has launched a COVID-19 test – Technical.ly DC

Sterling, Virginia-based biotech company Aperiomics has launched a new test that can detect COVID-19.

Founded in 2014, the company uses genomic analysis and machine learning to detect known pathogens from a sample of any nature in just one test. Aperiomics reports that its Xplore-PATHO tech can accurately identify nearly 40,000 microorganisms including over 12,000 clinically relevant pathogens.

Image: An Xplore-COVID-19 testing kit from Aperiomics – Courtesy Photo

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FDA Just Approved a Rapid Coronavirus Test That Can Diagnose COVID-19 in 45 Minutes

The US Food and Drug Administration has approved a coronavirus test that can deliver a COVID-19 diagnosis in 45 minutes.

The test, made by California-based Cepheid, got emergency clearance on Saturday, eight days after the agency gave fast-track approval for a test by Roche, which can diagnose the novel coronavirus within three hours.

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These 17 Maryland biotech companies are collaborating in the fight against COVID-19 – Technical.ly Baltimore

As more cases of COVID-19 are being reported and leaders seek tests and treatments, biotech companies are stepping up efforts to develop new tests and treatments.

That includes Maryland, where life sciences companies are working on vaccines, therapeutics and diagnostics. They’re also seeking to share what they’re working on and offer up resources: On Friday, Maryland Life Sciences is putting together a call with more than 15 companies where they’ll look to connect and share needs.

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COVID-19 Reinfection Not a Concern, Monkey Study Suggests

Concerns about SARS-CoV-2 infection have reached an all-time high in the United States and around the globe. With increasing numbers of COVID-19 cases, hospitalizations, and deaths—and “social distancing” now a household word—the possibility of being infected is on everyone’s mind.

As if that weren’t enough to worry about, the surfacing of multiple personal accounts—primarily out of China and Japan—of patients who recovered after infection only to fall ill a second time, have some worried about the possibility of reinfection.

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Lung Bioengineering in Silver Spring evaluates donated lungs to determine if they are suitable for transplant

Heather Phillips was supposed to be getting ready to join her extended family at its annual pumpkin carving celebration in Clarksburg, but instead she was still at work at Lung Bioengineering in downtown Silver Spring. It was late on a Saturday morning in October, and she’d been working all night. Now she stood inside the loading dock of the two-story building awaiting, for the third time in 12 hours, the delivery of an insulated cardboard box filled with ice and a pair of human lungs.

Image: Specialists Sam Popa (left) and Erin Larrabee prepare a set of lungs in a Lung Bioengineering operating room. Photo by Lisa Helfert

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Aurinia Pharmaceuticals, helmed by Peter Greenleaf, expands into Rockville – Washington Business Journal

A Canadian pharmaceutical company is expanding into Rockville about a year after an executive with a long history in Maryland’s bioscience industry took the helm.

Aurinia Pharmaceuticals Inc. of Victoria, British Columbia, announced plans to open a new office in the city of Rockville on Tuesday, bringing about 100 employees to 30,000 square feet. The company could someday expand to employ as many as 500 people and occupy up to 120,000 square feet in Rockville during the next seven years, depending on its success in securing federal approvals for one of its drugs.

Image: Peter Greenleaf, a biotech executive with lots of history locally, is bringing his latest company to Rockville. JOANNE S. LAWTON

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Biobuzz Directory – Immunomic Therapeutics Announces Completion of Pre-IND Meeting With US FDA for ITI-1001, a Vaccine for the Treatment of GBM

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001. The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM).

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Biobuzz Directory – Aurinia Pharmaceuticals to Bring 500 New Jobs to Maryland at New Commercial Operations Center in Rockville

VICTORIA, British Columbia–(BUSINESS WIRE)–

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced that the Company has established its U.S. commercial center of operations in Rockville, Maryland. The new site will support Aurinia’s plans for growth as it prepares for the potential approval and launch of voclosporin for the treatment of lupus nephritis in 2021.

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Why Investment And IP Clustering Is Key To An Innovative Future Across The Globe, With Joel Marcus

Joel S. Marcus is the Executive Chairman and Founder of Alexandria Real Estate Equities, Inc. (NYSE:ARE), an urban office REIT and the first and longest-tenured owner, operator and developer uniquely focused on collaborative life science, technology and ag-tech campuses in AAA innovation cluster locations. Mr. Marcus co-founded Alexandria in 1994 as a garage startup with $19 million in Series A capital. As CEO from March 1997 to April 2018, he led its growth into an investment-grade-rated S&P 500 company.

Image: https://www.forbes.com

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Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization

INDIANAPOLIS, March 16, 2020 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has begun shipping the first allotment of its cobas® SARS-CoV-2 Test for COVID-19 (coronavirus) to a network of hospital and reference laboratories across the U.S. to enable automated, high-volume patient testing. Shipping of the initial 400,000 test kits began Friday, March 13, and will be completed this week. Roche plans to ship an additional 400,000 tests per week to the laboratory testing sites across the nation that are set up to run the test immediately under the guidelines of the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

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Startups developing tech to combat COVID-19 urged to apply for fast-track EU funding | TechCrunch

The European Commission put out a call Friday for startups and small businesses which are developing technologies that could help combat the COVID-19 outbreak to apply for fast-track EU funding.

The push is related to a €164M pot of money that’s being made available for R&D via the European Innovation Council (EIC) — a European Union funding vehicle which supports the commercialization of high risk, high impact technologies.

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GeneDx Celebrates 20 Year History as Pioneer In Genetic Sequencing and Testing · BioBuzz

GeneDx, a global leader in genomics and patient testing, is celebrating its remarkable 20th anniversary throughout the month of March.

The Gaithersburg, Maryland company has played an important role in the history of genetic sequencing and the rise of the BioHealth Capital Region as a global biohealth cluster. GeneDx was the very first company to commercially offer NGS (Next Generation Sequencing) testing in a CLIA (Clinical Laboratory Improvement Amendments) lab and has been at the leading edge of genetic sequencing and testing for two decades. The company’s whole exome sequencing program and comprehensive testing capabilities are world-renowned.

Image: https://biobuzz.io

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Study Shows How Mild Coronavirus Infection is Beaten by Immune Response

Researchers at the Peter Doherty Institute for Infection and Immunity in Australia have mapped immune responses in a patient in response to COVID-19 infection, demonstrating the body’s ability to fight the virus and recover from the infection. The team tested blood samples taken from one of Australia’s first cases of COVID-19, at four different time points during the infection. “We looked at the whole breadth of the immune response in this patient using the knowledge we have built over many years of looking at immune responses in patients hospitalized with influenza,” said Oanh Nguyen, PhD, co-author of the researchers report, which is published in Nature Medicine.

Image: Outbreak response in action: Centers for Disease Control and Prevention (CDC) staff support the COVID-19 response in the CDC’s Emergency Operations Center (EOC). (CDC; photo credit James Gathany)

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GSK, AstraZeneca, Genentech, and Novartis Identified as the Top Companies Driving Therapeutic Innovation in Asthma

MORRISTOWN, N.J., March 18, 2020 /PRNewswire/ — In an ongoing series of research conducted by KMK Consulting, Inc. covering Innovation & Customer Value, GSK was ranked as the top company delivering superior customer value and sales force engagement, as well as delivering therapeutic innovation in the asthma market according to pulmonary disease specialists. The research was conducted in February 2020, using KMK’s Rapid Pulse Survey platform. AstraZeneca, Genentech, and Novartis rounded out the top organizations driving innovation and customer value in this space.

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Trials to begin on Covid-19 vaccine in UK next month | Health | The Guardian

A massive effort is under way to develop a UK vaccine for coronavirus within months and make it available to save lives before the end of the year, the Guardian has learned.

Researchers at Oxford University, led by Prof Sarah Gilbert, are planning a safety trial on humans of what is expected to be the UK’s first coronavirus vaccine next month. Provided that it goes smoothly, they will move directly into a larger trial to assess how effective the vaccine is at protecting against the infection.

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Council Post: How Digitizing Healthcare Can Transform Patient Care

The biopharma industry spent $90 billion on R&D in 2016, a figure that represents about 20% of total sales. Despite this significant financial investment by the industry and splashy media headlines, how much, or little, is healthcare really digitizing?

During the 2020 JP Morgan Healthcare Conference, a panel of senior executives, including Brent Saunders, chairman, president and CEO of Allergan, Tariq Shaukat, president of industry product and solutions for Google Cloud, and Sara Nayeem, MD, partner at New Enterprise Associates, joined me to share their perspectives and insights on how biopharma and medtech companies are driving digital health.

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Maryland Industrial Partnerships (MIPS) – SPRING 2020 UPDATE

Despite the serious impacts of the coronavirus, MIPS is continuing its normal business activities, although we have moved many of our operations online. Our upcoming round of proposals are due May 1 at 5 p.m. We continue to work with the Maryland business and academic communities to support your efforts to develop technology products and services. Now is an excellent time to develop new products in order to have them ready for market when the U.S. economy begins to recover in the not-too-distant future.

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Thermo Fisher Scientific Continues Investments to Accelerate Biopharma Commercialization

NEEDHAM, Mass., March 23, 2020 /PRNewswire/ — For biopharma companies faced with increasing demand for new biologics, cell and gene therapies, and drug products, Thermo Fisher Scientific is investing more than $475 million in new capabilities and capacity in 2020. This investment, in addition to those made in 2019, brings the total investment over two years to approximately $800 million across the company’s pharma services business.

“We’ve invested strategically to ensure that lack of capabilities, capacity or supply is never a reason medicines are delayed in reaching patients,” said Mike Shafer, president, Thermo Fisher’s pharma services business. “Our offering can provide solutions at all points along the pathway to commercialization, whether it’s an emerging biotech working on vaccine for a novel virus or a high-volume pharmaceutical manufacturer delivering necessary drugs at scale.”

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The Zidd and Fizz Show

Keeping angels and startups company while working from home! Great guests and great topics! The ZIDDANDFIZZ Show: Angels Talk Ziad Henry Moukheiber Faz Bashi hashtag#podcasting hashtag#podcasts

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Cellphire Begins Phase 2 Trial of Thrombosomes® in Bleeding Thrombocytopenic Patients

ROCKVILLE, Md., March 18, 2020 /PRNewswire/ — Cellphire, Inc., the global leader in long-term stabilization and storage of platelets, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to start a Phase 2 clinical trial of Thrombosomes in bleeding patients with thrombocytopenia.

In July 2019, Cellphire successfully completed a Phase I clinical trial of its lead product, Thrombosomes, a platelet-based freeze-dried hemostatic. Utilizing its patented technology to stabilize and freeze-dry platelets, Cellphire is developing next-generation therapeutics to treat bleeding patients. Standard liquid platelets only have a 5- to 7-day shelf life, making inventory management difficult and can lead to widespread platelet shortages during public health emergencies. By contrast, Thrombosomes have a 3-year shelf life.

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2017
All Rights Reserved.



395th Edition – March 3, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


March 9, 2020












FOUNDING MEMBER OF



BioHealth Capital Region Forum 2020 (April 14-15) – Register Now

Register Now for the 6th Annual BioHealth Capital Region (BHCR) Forum held on April 14-15 at AstraZeneca in Gaithersburg, MD. Join your peers biotech and life science executives and expert speakers from industry, academia, healthcare, government, finance and real estate development, among others, converged to discuss the BHCR’s path forward to becoming a top three U.S. biotech cluster by 2023.

Register Now

 

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Northern Powerhouse Life Sciences and Healthcare Showcase Event (Tuesday, March 3, 2020)

We would like to invite you to join leading companies from the Northern Powerhouse region of England for a morning of presentations and networking. The delegation is visiting the Capital Region to help build relationships with key decision makers and build close trade and collaboration ties.

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Novavax Advances Development of Novel COVID-19 Vaccine | Novavax Inc. – IR Site

GAITHERSBURG, Md., Feb. 26, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced progress in its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19. Novavax has produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing, which is expected to begin by the end of spring 2020.

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Arcellx Announces First Patient Treated with T Cell Therapy Utilizing the Company’s Novel Binding Domain

GAITHERSBURG, Md., Feb. 28, 2020 (GLOBE NEWSWIRE) — Arcellx today announced that the first patient has been dosed with its engineered T cell therapy utilizing a novel deimmunized synthetic binding domain in the treatment of patients with relapsed and refractory multiple myeloma. This first-in-human Phase 1 trial is the first in a series of clinical trials planned for efficient, stepwise development of the Arcellx ARC-T + sparX cell therapy platform, with BCMA as an initial target.

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Pink Equity: The Power Of The Female Dollar (March 12, 2020)

Who runs the healthcare world? Women make 80% of all buying decisions and make up over 70% of the healthcare workforce—yet in 2020 we still do not have an equal voice in the ranks of leadership.

Diversity is also an issue when it comes to venture capital. Female entrepreneurs continue to struggle to raise as much capital as their male counterparts. Although capital investment in all-female founding teams hit an all time high of $3.3 billion in 2019, it represented only 2.8% of capital invested across the entire U.S. startup ecosystem.

Join JLABS for an evening panel discussion as we tackle these issues, and discuss avenues for capital, while forging a path forward for two of the most prohibitive factors at play: a lack of a robust network of female mentors and lack of investment dollars in female-led startups. 

 

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Interactive map from Johns Hopkins shows coronavirus spread in real-time

The map allows you to see which parts of the world are impacted the most by it.

A chart is placed to the left of the map showing the number of confirmed cases for specific countries, states, and cities.

Two charts are placed to the right of the map.

Image: https://www.arcgis.com/

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IBBR Researchers Awarded $850K from NSF to Study How Plants Defend Against Fungal Invasion | Institute for Bioscience and Biotechnology Research

(Rockville, MD, February 25, 2020) Researchers at the Institute for Bioscience and Biotechnology Research (IBBR) recently received $850K from the National Science Foundation (NSF) to advance our understanding of how fungi like powdery mildew infect plants including food source crops, and how plants fight back. IBBR Fellow Dr. Shunyuan Xiao (Professor, Department of Plant Sciences and Landscape Architecture, University of Maryland College of Agriculture & Natural Resources) is the principal investigator on the award.

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United Therapeutics and DEKA Announce Additional FDA Clearance Related to the Unity Subcutaneous Delivery System for Remodulin® | BioSpace

RESEARCH TRIANGLE PARK, N.C. and MANCHESTER, N.H., Feb. 24, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) and DEKA Research & Development Corp. today announced receipt of an additional 510(k) clearance by the U.S. Food and Drug Administration (FDA) related to the Unity Subcutaneous Delivery System for Remodulin® (treprostinil) Injection, also referred to as the Remunity™ pump, enabling United Therapeutics to launch the system using drug reservoirs that have been prefilled by specialty pharmacies.

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Capsulomics establishes $3.7 million NIH-funded research collaboration with Johns Hopkins University

BALTIMORE, Feb. 25, 2020 /PRNewswire/ — Capsulomics, Inc., a Baltimore-based molecular diagnostics company whose mission is to detect and prevent cancer through earlier detection, today announced a research partnership with Johns Hopkins University, funded by a 5-year, $3.7 Million NIH Academic-Industrial Partnership grant, to conduct an important clinical research study to detect esophageal cancer and its precancerous precursor condition, Barrett’s esophagus (BE).

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Poets&Quants | $25 Million To Accelerate Johns Hopkins’ MBA Makeover

Alex Triantis, dean of the Carey Business School at Johns Hopkins University in Baltimore, Maryland, says a new $25 million gift from the school’s namesake foundation will go toward accelerating the transformation of the MBA curriculum into a much more healthcare-oriented experience, among other uses. Carey photo

At Johns Hopkins University, nearly a quarter of the Carey Business School’s full-time faculty study or teach in health-related fields. About 38% of current full-time MBA students and 35% of part-time MBA students focus on health-related areas of study.

Image: https://poetsandquants.com

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Congratulations to Sonavex, Inc. CEO David Narrow on being selected as an Innovation Leader at Emerging Medtech Summit 2020.

Congratulations to Sonavex, Inc. CEO David Narrow on being selected as an Innovation Leader at Emerging Medtech Summit 2020.

More: https://lnkd.in/e3Z8fUv

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Maryland Commerce releases FY19 annual report | Maryland Business News

Over the past year, the Maryland Department of Commerce has continued to foster business growth throughout the state, by simplifying the process of starting a business, prioritizing customer service, and investing in our innovative companies.

During fiscal year 2019, the department provided financial assistance to 167 different economic development projects statewide, from Kite Pharma in Frederick to Smithfield Foods in Cecil County, bringing in a total capital expenditure of $630.5 million. More than 70 of these projects fell under the small, minority, and women-owned business category, according to the recently released annual report.

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NIH Is Supporting Entrepreneurs To Address The Looming Public Health Crisis: Life Science Nation Interview with Todd Haim, Ph.D., Chief, Office of Small Business Research, National Institute on Aging, National Institutes of Health | Next Phase Newsletter

Todd Haim(TH): I began working on small business grant programs at the National Institutes of Health (NIH) more than 10 years ago when I joined the National Cancer Institute (NCI) as an AAAS Science and Technology Policy Fellow. After 9 years at NCI, I was asked to lead the launch of a new Office of Small Business Research (OSBR) at the National Institute on Aging (NIA). NIA’s OSBR was created just over 1 year ago. It serves as the main coordinating office for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants that are awarded to companies working on solutions to address aging and aging-related diseases.

Image: https://blog.lifesciencenation.com

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This Philly lawyer is building three new venture capital funds to invest millions in start-ups

“Philadelphia was an innovation and investment backwater,” but Ajay Raju says it’s headed for venture capital’s mainstream, and he’s personally setting up the partnerships to make it happen, pledges the real estate finance lawyer and chairman of the law firm Dilworth Paxson.

Image: ANDREW THAYER / FILE PHOTOGRAPH

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Changes Recommended for Keystone Innovation Zone Tax Credit – Smart Incentives

Pennsylvania’s Independent Fiscal Office has suggested making the Keystone Innovation Zone (KIZ) tax credit refundable, which would eliminate the portion of the tax credit going to tax brokers and increase the funding available to target businesses. Other proposed changes would strengthen the applicant review process and expand data collection to improve program accountability.

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396th Edition – March 10, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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March 10, 2020












FOUNDING MEMBER OF



Chris Frew, Founder of BioBuzz and Workforce Genetics, Joins Rich Bendis on BioTalk

BioBuzz and Workforce Genetics Founder, Chris Frew, Joins BioTalk to discuss building two organizations, talent acquisition, and his role in the BioHealth Capital Region ←Sub title

Chris is the Founder and CEO of Workforce Genetics, LLC (WGx), and BioBuzz Media to foster highly engaging experiences that connect people and companies across biohealth ecosystems. His insights into talent attraction, employer branding, and marketing have helped top companies to tackle their most pressing challenges in the new talent economy. Previously as Vice President at Breezio, a leading innovator in cloud-based online communities, he lead the development of the new Internship Network of Maryland (inMD) platform that was approved by Gov. Hogan in 2017. As Vice President of Tech USA’s Scientific Division Chris founded and ran a national staffing division operating at $23M annually when he left in 2015. Chris is passionate about impacting others, especially his family and his team, and helping to foster a strong community within the BioHealth Capital Region. He is a Maryland native and a graduate of Towson University. Learn more at https://www.workforcegenetics.com/ and http://biobuzz.io/

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BioHealth Capital Region Forum 2020 (April 14-15) – Register Now

Register Now for the 6th Annual BioHealth Capital Region (BHCR) Forum held on April 14-15 at AstraZeneca in Gaithersburg, MD. Join your peers biotech and life science executives and expert speakers from industry, academia, healthcare, government, finance and real estate development, among others, converged to discuss the BHCR’s path forward to becoming a top three U.S. biotech cluster by 2023.

Register Now

 

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BHI Recruiting a Senior Analyst, Immediate Opening.

OVERVIEW

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking a life sciences professional with consulting, market research and/or portfolio management experience to join the BHI’s team and serve as a Senior Analyst, Ph.D. to manage and support the Analyst team through training and front facing of potential start-up CEOs and Companies.

POSITION DESCRIPTION – Senior Analyst, Ph.D.

The Senior Analyst will manage the analysts and provide project support and guidance to the team as well as to new entrepreneurs on projects including SBIR Grants, corporate and private investments. This will entail market, technology, regulatory and other business intelligence research to support BHI consulting, coaching of companies and the Analyst team profit center. This is a hands-on leadership position. 

Download the Full Job Description.

 

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Deals News: Thermo Fisher Scientific to Buy Qiagen for $12 Bln – Bloomberg

U.S. laboratory equipment maker Thermo Fisher Scientific Inc. agreed to buy Qiagen NV, a Dutch maker of tests for diseases including cancer and the new coronavirus, for about 9 billion euros ($10 billion) in the biggest health-care acquisition so far this year.

Investors will get 39 euros in cash for every Qiagen share, Thermo Fisher said Tuesday. That’s 23% higher than Monday’s closing price. Qiagen also sells products for food and forensic testing. Bloomberg earlier reported the companies were nearing a deal after reviving discussions that broke off late last year.

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Coronavirus vaccine news boosting Gaithersburg’s Novavax – Washington Business Journal

Novavax Inc. is already cashing in on its stock spike after announcing plans to develop a vaccine for the COVID-19 coronavirus.

The Gaithersburg biotech has raked in $98.7 million in net proceeds this quarter from selling 10.5 million shares of common stock at $9.55 per share, the company reported Monday in Securities and Exchange Commission filings. And it could sell up to $150 million more in common stock shares, the company said.

Novavax’s (NASDAQ: NVAX) stock was trading at $12.09 per share Monday early afternoon — which, though down about 24% from Friday’s close (as stocks see general volatility amid the coronavirus outbreak), is still notably high for the Maryland biotech.

Image: Novavax is developing a vaccine candidate for the COVID-19 coronavirus. This Centers for Disease Control and Prevention illustration shows the structure of coronaviruses. CENTERS FOR DISEASE CONTROL AND PREVENTION

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CEL-SCI Initiates Development of Immunotherapy to Treat COVID-19 Coronavirus Infection | Benzinga

CEL-SCI Corporation (NYSE:CVM) announces that it is developing an immunotherapy with the potential to treat the COVID-19 coronavirus using its patented LEAPS peptide technology. The LEAPS peptides will utilize conserved regions of coronavirus proteins to stimulate protective cell mediated T cell responses and reduce viral load. The LEAPS peptide technology can be used to construct immunotherapeutic peptides that exhibit both antiviral and anti-inflammatory properties. Consequently, these products not only target the virus infection against which they are directed, but also elicit the appropriate protective response(s) against it.

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Amazon Web Services, Montgomery College, George Mason University Announce the College’s First Bachelor’s Degree for Cloud Computing – MC News

Montgomery College and George Mason University (Mason), in collaboration with AWS Educate, will partner to create a Bachelor of Applied Science (BAS) pathway in cloud computing. This degree offers students a seamless transfer pathway from a two-year associate’s degree to a four-year bachelor’s degree in cloud technology, providing a clear path to high-demand careers in cloud computing with AWS (Amazon Web Services) partners and customers.

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BioHealth CXO/Consulting Database

Are you an experienced biohealth industry executive seeking full time or part time employment as a consultant or start-up C suite executive? BioHealth Innovation is updating its database of experienced industry executives who may be able to share their expertise with early stage/growing companies. To be considered by companies or technology transfer organizations seeking leaders for their spin-out companies and/or advisors to support their business growth, please this form and upload a copy of your resume. (For questions/more information, please email: BHI@BioHealthInnovation.org.)

 

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Innate Pharma

Tomorrow and every day, we recognize the hashtag#RareDisease community on behalf of the Innate Pharma team. We do what we do because of you. hashtag#RareDiseaseDay hashtag#WRDD hashtag#HairyCellLeukemia hashtag#cutaneouslymphoma hashtag#SézarySyndrome hashtag#MycosisFungoides

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Immunomic Therapeutics Announces Completion of Pre-IND Meeting with US FDA for ITI-1001, a Vaccine for the Treatment of GBM – Bloomberg

Immunomic Therapeutics, Inc., a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001. The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM).

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CORRECTING and REPLACING Neuraly Announces First Patient Dosed in Phase 2 Clinical Trial of NLY01 for Patients with Parkinson’s Disease | Business Wire

NEURALY ANNOUNCES FIRST PATIENT DOSED IN PHASE 2 CLINICAL TRIAL OF NLY01 FOR PATIENTS WITH PARKINSON’S DISEASE

Novel Mechanism of Action Inhibits Pathological Activation of Microglial Cells and Prevents Neuronal Cell Death

Neuraly, a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced the dosing of the first patient in its Phase 2 clinical trial of NLY01 for Parkinson’s disease.

“Current therapies for Parkinson’s disease provide only temporary symptomatic improvement and fail to slow or halt the relentless progression of the disease,” said Seulki Lee, Ph.D., President and Chief Executive Officer of Neuraly. “The initiation of this Phase 2 study is an important milestone in the ongoing advancement of NLY01 which we believe has the potential to be a ground-breaking therapy for Parkinson’s patients based on results we have seen to date in preclinical trials.”

 

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Mason to unveil a new Cyber Living Innovation Lab as part of the CCI | George Mason

A Cyber Living Innovation Lab with robotic platforms to evaluate 5G performance and a fleet of driverless cars will provide experiential learning opportunities to students from universities across the region as the anchor of George Mason University’s cybersecurity research expansion, thanks to $2.5 million in funding as part of a statewide initiative.

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HHS Solicits Proposals for Development of Medical Products for Novel Coronavirus | HHS.gov

As part of the government-wide effort to mitigate the spread of COVID-19 in U.S. communities, the U.S. Department of Health and Human Services (HHS) has updated a broad agency announcement (BAA) to focus specifically on products to diagnose, prevent or treat coronavirus infections.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), issued the BAA, BAA-18-100-SOL-00003-Amendment 13, to solicit proposals for advanced development and licensure of COVID-19 diagnostics, vaccines, or medicines such as therapeutics or antivirals.

“Amid the expanding global outbreak of COVID-19, Americans need diagnostics, vaccines, and medicines to mitigate the potential impact of this virus”, said BARDA Director Rick Bright, Ph.D. “To accelerate the availability of these lifesaving tools, BARDA took an important step today to request proposals for development of COVID-19 diagnostics, vaccines, or therapeutics, many of which will be developed using existing platform technologies to permit rapid development.”

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Alexandria Real Estate Equities, Inc. and Executive Chairman and Founder Joel S. Marcus Honored With the 2020 Navy SEAL Foundation Patriot Award

PASADENA, Calif. and NEW YORK, March 6, 2020 /PRNewswire/ — Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, and its executive chairman and founder, Joel S. Marcus, were honored to receive the 2020 Navy SEAL Foundation Patriot Award. This recognition highlights Alexandria’s contributions to our nation and unwavering support for the Naval Special Warfare community, as well as its embodiment of the values that epitomize the SEAL community. Congressional Medal of Honor recipient and retired U.S. Navy Master Chief Special Warfare Operator Britt Slabinski presented the prestigious award to Mr. Marcus yesterday evening during the Navy SEAL Foundation’s 12th annual New York City Benefit Dinner celebrating the Foundation’s 20th anniversary.

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The best, and the worst, of the coronavirus dashboards – MIT Technology Review

If you’ve been on the web to learn more about the latest pandemic, chances are you’ve stumbled upon at least one or two coronavirus dashboards. These are the landing pages for interactive maps and visuals that show where the virus has spread, as well as numbers on the latest in infection rates and deaths, breakdowns of what countries are suffering from new cases and what regions are likely seeing new outbreaks, and much more.

Image: UPCODE ACADEMY

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Maryland Economic Development Association Announces 2020 Award Winners

The Maryland Economic Development Association (MEDA) is proud to announce the winners of the 2020 MEDA Awards. The 2020 awards, sponsored by Miles & Stockbridge P.C., recognize the exceptional people, programs and projects that bring economic prosperity to Maryland.

“We’d like to thank all who submitted a nomination for recognizing such deserving programs, projects and individuals, and our awards judges for their hard work determining the winners,” says Pamela Ruff, MEDA executive director. “The 2020 winners exemplify the Maryland communities that are going above and beyond when it comes to economic expansion and prosperity.”

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Northern UK Trade Mission to the BioHealth Capital Region with British Department of Trade and Industry of the UK Embassy at AstraZeneca

Northern UK Trade Mission to the BioHealth Capital Region with British Department of Trade and Industry of the UK Embassy at AstraZeneca

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Baltimore: poised for a revolution in health business | COMMENTARY – Baltimore Sun

The region’s politicians and business leaders are mourning the fact Baltimore stands to lose another headquarters of a prestigious, publicly traded company with the news that Legg Mason Inc. was acquired by Franklin Resources Inc. But investors should remain bullish about the city’s business future. The acquisition of Legg Mason was part of a natural cycle of industry consolidation and not a measure of Baltimore’s business climate. In fact, Baltimore and the surrounding region are poised to lead a business revolution in health.

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How to Conquer Coronavirus: Top 35 Treatments in Development

As the world scrambles to monitor and contain the COVID-19 outbreak, drug companies are racing to develop or repurpose treatments to combat the potential pandemic. The death toll continues to climb. The first U.S. death associated with the SARS-CoV-2 virus was reported in Washington state February 29. As of March 2, according to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University, 3,048 people in 11 countries had died worldwide, nearly all of them (96% or 2,914) in China.

Image: Credit: NASA/Johns Hopkins University Applied Physics Laboratory/Southwest Research Institute/Roman Tkachenko

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Southern Maryland’s 6th Annual Crab Pot Pitch Competition – Speed Rounds Tickets, Thu, Apr 9, 2020 at 6:00 PM | Eventbrite

What is Crab Pot?

The Crab Pot Pitch Competition is Southern Maryland’s premier pitch competition for entrepreneurs with cutting edge, disruptive and innovative technologies. Made popular by television shows like ABC’s “Shark Tank,” pitch contests provide an opportunity for entrepreneurs to present their ideas to a panel of judges or investors in front of an audience.

Crab Pot provides an opportunity for the community to celebrate the efforts of local entrepreneurs and innovators. Audience members get to see what entrepreneurs in Southern Maryland are up to. Crab Pot provides an opportunity for the community to celebrate the efforts of local entrepreneurs and innovators. Audience members get to see what entrepreneurs in Southern Maryland are up to. Entrepreneurs get to practice their pitches and win cash prizes. This year will be the 6th annual competition!

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U.S. IPO Week Ahead: One Biotech Takes On A Turbulent IPO Market | Seeking Alpha

Facing record-high volatility and market uncertainty, one biotech is scheduled for the week ahead.

Formed by New Enterprise Associate’s orphan drug accelerator Cydan, genetic disorder biotech Imara (IMRA) plans to raise $76 million at a $301 million market cap. The Boston-based company’s sole candidate IMR-687 is a once-a-day therapy targeting sickle cell disease and beta-thalassemia by inhibiting PDE9. It is expected to begin a Phase 2b trial in the 1H20. While there is significant unmet medical need for both disorders, it is a crowded space, with three products approved in 2019.

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How to self-quarantine during coronavirus outbreak | Live Science

With more than 378 confirmed coronavirus cases in the U.S. and more than 15 associated deaths, the Centers for Disease Control and Prevention (CDC) is actively monitoring, and trying to contain, the transmission of the disease, called COVID-19.

In some cases, depending on risk level, the CDC may ask individuals or families to self-quarantine or remain in isolation. Here’s a look at what that means and tips for implementing such measures.

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Innovationeering: What’s your (innovation) number?

In this age of near-exclusive reliance on electronic communication, practically nobody asks for your number any longer — we just text, email or AirDrop critical identifiers.

However, some of us still must record our activities numerically, and innovators are certainly not immune from exchanging numbers — usually with interested leaders or colleagues, for the purpose of benchmarking.

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STAT Madness has begun. Vote for the best innovations in biomedicine – STAT

This is our fourth annual STAT Madness, a bracket-style tournament to find the best innovations in science and medicine.

The second round of voting begins Monday, March 9 at 12 a.m. EDT and is open until Sunday, March 15 at 11:59 p.m. EDT.

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What’s Behind Novavax’s Coronavirus/COVID-19 Vaccine Development Program · BioBuzz

The BioHealth Capital Region (BHCR) has a long history of leading the fight against new, frightening diseases, like Ebola and the novel Coronavirus (COVID-19) which is quickly spreading across the globe. Leading public health agencies such as the World Health Organization (WHO) and others believe the COVID-19 virus has the potential to reach pandemic levels as infection numbers rise beyond China’s borders.

Image: https://www.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

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Thermo Fisher Acquiring Qiagen For €9 Billion: Details About The Deal You Should Know

As one of the largest healthcare tech deals in 2020, Thermo Fisher is buying coronavirus diagnostics company Qiagen NV for €9 billion. QIAGEN is considered a leading global provider of molecular diagnostics and sample preparation technologies. The deal has been approved by the boards of directors at both companies as well as the managing board of QIAGEN.

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Home | About BHI | BHI News | Programs | Partners | Contact

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All Rights Reserved.



397th Edition – March 17, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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March 17, 2020












FOUNDING MEMBER OF



BioHealth Capital Region Forum Postponed Due to COVID-19 Outbreak – BioHealth Capital Region

The BioHealth Capital Region Forum Planning Committee has made the difficult decision to postpone our 6th annual BioHealth Capital Region Forum that was scheduled for April 14th and 15th at AstraZeneca. We believe the health and safety of all participants is of paramount importance. Following the most recent reports from the CDC, the WHO, and the state of Maryland’s ban on gatherings of 250 people or more, we have made this decision.

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Stewart L. Edelstein, Ph.D., Executive Director of the Universities at Shady Grove, Joins Rich Bendis on BioTalk

Executive Director of the Universities at Shady Grove, Stewart L. Edelstein, Ph.D., joins BioTalk to discuss his career, USG, and its role in the BioHealth Capital Region

Dr. Stewart Edelstein joined the Universities at Shady Grove (USG) as Executive Director in 2002 and in 2007 was named to the dual title of Associate Vice Chancellor for Academic Affairs for the University System of Maryland (USM).

USG is a regional campus of USM that offers both undergraduate and graduate degree programs from nine partner universities. During Dr. Edelstein’s tenure, USG expanded its number of participating universities, as well as the breadth and depth of its academic programs, and enrollment has grown significantly, to more than 3,000 students. The campus’s capacity for future enrollment growth has doubled with the recent opening of a new Biomedical Sciences and Engineering Education Facility, which is expanding degree and certification offerings in healthcare, engineering, biosciences, computer science and other areas.

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Entrepreneur- in-Residence Feedback Session (videoconference)

In accordance with state and federal recommendations to combat COVID19, BioHealth Innovation has modified the EIR Feedback Sessions for the near future to take place by videoconference only.   There now are a couple openings tomorrow (3/18).  To participate in this session, please register using this link www.tinyurl.com/EIR feedback and send your ppt presentation including the top 3 topics on which you would like feedback to BHI@BioHealthInnovation.org by 2 p.m. 3/17/20.  The next sessions are scheduled to take place by videoconference on 4/22 and 5/27.

(by videoconference)

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BHI Recruiting a Senior Analyst, Immediate Opening.

OVERVIEW

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking a life sciences professional with consulting, market research and/or portfolio management experience to join the BHI’s team and serve as a Senior Analyst, Ph.D. to manage and support the Analyst team through training and front facing of potential start-up CEOs and Companies.

POSITION DESCRIPTION – Senior Analyst, Ph.D.

The Senior Analyst will manage the analysts and provide project support and guidance to the team as well as to new entrepreneurs on projects including SBIR Grants, corporate and private investments. This will entail market, technology, regulatory and other business intelligence research to support BHI consulting, coaching of companies and the Analyst team profit center. This is a hands-on leadership position. 

Download the Full Job Description.

 

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The life sciences industry has posted gains in the DMV. Here’s what it will mean for jobs – Technical.ly DC

It’s at the center of some of the most groundbreaking work to advance human ingenuity in the region — and save lives. And, economically, it’s been home to some of the biggest news about M&A activity, venture capital and job growth. When it comes to growing industries, the life sciences sector is among the most impactful in the area. Spanning hospital research labs and manufacturing centers where production takes place, harnessing living cells to create new treatments and other biotech, biomedical and pharma work is happening in a footprint that knits together Baltimore, the Maryland suburbs, D.C. and Northern Virginia.

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Emergent BioSolutions Signs Development and Manufacturing Agreement With Novavax for Experimental Vaccine Candidate for Coronavirus Disease | Emergent BioSolutions Inc.

GAITHERSBURG, Md., March 10, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Novavax, Inc. (NASDAQ:NVAX) whereby Emergent will collaborate with Novavax, utilizing its molecule-to-market contract development and manufacturing (CDMO) services to support bringing into the clinic Novavax’s novel experimental vaccine candidate to protect against coronavirus disease (COVID-19). Under the terms of the agreement, Emergent will produce the COVID-19 experimental vaccine candidate, which is based on the proprietary recombinant protein nanoparticle technology platform of Novavax and utilizing their proprietary Matrix-M™ adjuvant to enhance immune responses. Emergent has initiated work for this program anticipating that the COVID-19 experimental vaccine candidate will be used in a Phase 1 clinical study within the next four months.

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Emergent Biosolutions, Inc. (NYSE:EBS), Novavax, Inc. (NASDAQ:NVAX) – Emergent BioSolutions CEO Talks Coronavirus Vaccine Development | Benzinga

Global life sciences company Emergent Biosolutions Inc EBS 6.61% CEO Bob Kramer said Thursday that his company’s partnership with Novavax, Inc. NVAX 6.3% could result in the creation of a therapy that poses a “fairly low risk.”

Emergent Has Past Experience With Anthrax, Botulism Emergent is using its own platform to help Novavax with the creation of a coronavirus vaccine, Kramer said during a guest appearance on CNBC’s “Squawk Box” segment Thursday morning.

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FDA Clears First Clinical Study for a Polymicrobial Phage Library-Based Treatment for Antibiotic-Resistant Infections | Business Wire

GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank™, a personalized bacteriophage therapeutic for the treatment of MDR and complicated bacterial infections. The Phase 1/2 trial represents the first study of an expanding phage library under FDA allowance for a multi-site study of intravenous administration and/or bladder instillation of phage therapy. Beginning in Q2, APT will enroll patients at up to three clinical sites for the evaluation of PhageBank for the treatment of complicated and chronic recurrent urinary tract infections (UTIs).

 

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QIAGEN Gains BARDA Funding for Approval Process of QIAstat-Dx Test Kit for SARS-CoV-2 Coronavirus

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it will develop a new QIAstat-Dx test kit to differentiate the novel SARS-CoV-2 coronavirus from 21 other serious respiratory infections and will receive advanced development support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). Accelerated development of the QIAstat-Dx test kit further expands QIAGEN’s global mobilization for the emergency, which already includes a dramatic increase in production of components for a full range of U.S. and international testing protocols.

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Roche gets special FDA nod for Covid-19 diagnostic test – MedCity News

The Food and Drug Administration has given an emergency approval to a test made by Swiss drug and diagnostics maker Roche for detecting the Covid-19 virus.

The company said Friday that the FDA had approved an emergency use authorization, or EUA, to its Cobas SARS-CoV-2 test. The test is designed to use nasopharyngeal and oropharyngeal swab samples to detect the coronavirus using Roche’s Cobas 6800 and 8800 lab-testing systems. The systems are designed to provide thousands of results over a 24-hour period, the company said.

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Baltimore health tech startup b. well Connect Health raises $16M – Baltimore Business Journal

Baltimore health tech startup b. well Connected Health has raised a $16 million round as it looks to accelerate its growth.

The Series A round was led by UnityPoint Health Ventures, the venture capital arm of UnityPoint Health, an Iowa-based health system. Other investors include Wisconsin-based community health system ThedaCare and Well Ventures, a subsidiary of Walgreens Boots Alliance Inc., according to a release. The five-year-old company has previously raised $11.5 million in seed funding, bringing its total funding to over $27 million. In 2018, b. well also raised a total of $8.2 million in convertible debt funding from more than 60 investors.

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NEA Closes On $3.6B for New Fund with Focus on Early-Stage Technology and Healthcare Investments

MENLO PARK, Calif. and NEW YORK, March 11, 2020 /PRNewswire/ — New Enterprise Associates, Inc. (NEA) today announced that it has closed on $3.6 billion for its latest fund, bringing the firm’s committed capital to nearly $24 billion over its 42-year history. In conjunction with the new fund, Liza Landsman has been named General Partner. Landsman, who joined the firm’s New York office as a Venture Partner in 2018 after serving as president of NEA portfolio company Jet.com, focuses on software and services investments across the consumer landscape.

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FDA Releases Final Guidance: Transition of Previously Approved Drugs to Being “Deemed Licensed” Biologics | Wilson Sonsini Goodrich & Rosati – JDSupra

U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons. Contrastingly, biologic drugs are larger and more complex molecules, for example proteins, viruses, and living cells such as CAR-T cells.

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CEPI expands investment in COVID-19 vaccine development – CEPI

OSLO, NORWAY, March 10, 2020 – CEPI, the Coalition for Epidemic Preparedness Innovations, today announced the expansion of its COVID-19 vaccine portfolio. CEPI will be investing a further $4.4 million in partnering agreements with Novavax, Inc. and The University of Oxford to rapidly develop vaccine candidates against COVID-19. This brings CEPI’s total investment in COVID-19 vaccine R&D to $23.7 million.

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Welldoc Announces Collaboration with Dexcom to Enhance the Value of BlueStar® with the Dexcom G6® CGM System | Welldoc Inc

Columbia, MD – March 11, 2020 – Welldoc, a leading digital health company, announced today a collaboration with Dexcom, the global leader in continuous glucose monitoring (CGM) systems for people with diabetes. Welldoc and Dexcom signed an initial data partnership in 2019. This new collaboration will allow Welldoc’s award-winning BlueStar®, a digital health product for individuals living with type 1 and type 2 diabetes, to deliver insights to Dexcom G6® CGM system users. These insights go beyond glucose trends to inform individuals how their glucose is being affected by other key parameters, including medication adherence, activity, nutrition, sleep and more. The parties will also explore additional opportunities with Welldoc customers to leverage a more integrated offering.

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Johns Hopkins microbiologists develop coronavirus screening test

BALTIMORE — Two Johns Hopkins microbiologists have developed an in-house coronavirus screening test that may soon allow the health system to test as many as 1,000 people per day.

Karen Carroll, M.D., and Heba Mostafa, M.B.B.Ch., Ph.D are the microbiologists leading this.

“We will be able to diagnose more cases. This will allow the control of exposure,” said Mostafa, assistant professor of pathology and director of the molecular virology laboratory at The Johns Hopkins Hospital.

Image: Photo by: Johns Hopkins Medicine

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Gates Foundation, Wellcome, Mastercard launch $125M COVID-19 Therapeutics Accelerator – GeekWire

The Bill & Melinda Gates Foundation is teaming up with Wellcome and Mastercard to form the COVID-19 Therapeutics Accelerator, a $125 million effort to help find potential treatments for the coronavirus epidemic and future threats.

The accelerator will bring together the World Health Organization, pharmaceutical companies, biotech firms, government, and other philanthropic groups to develop therapies for COVID-19.

Image: Mark Suzman. (Gates Foundation Photo)

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FDA and FTC Send Joint Warning Letters to Seven Companies for “Selling Fraudulent COVID-19 Products” | Wilson Sonsini Goodrich & Rosati – JDSupra

The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number and severity of symptoms post-infection can vary by age and other risk factors (CDC Report). High level officials and politicians have been reported to be infected by, or in contact with, the virus. And there is no U.S. Food and Drug Administration (FDA) approved or licensed cure for COVID-19 (other than time, supportive measures as necessary, and a healthy immune system). “Although there are investigational COVID-19 vaccines and treatments under development, these investigational products are in the early stages of product development and have not yet been fully tested for safety or effectiveness.”

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Top 15 Best-Selling Drugs of 2019

GEN publishes its updated annual A-List highlighting the top 15 best-selling drugs of 2019. Eleven of last year’s 15 top-selling drugs registered year-over-year sales gains, with seven of the 11 racking up double-digit increases . . .

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All you need to know about TBS Osteo – Medimaps

All TBS Osteo features and main arguments. Included, in greater detail.

  • What is TBS Osteo powered by TBS iNsight and what is TBS (Trabecular Bone Score): the main arguments.
  • TBS Osteo compatibilities with different DXA systems.
  • Main evidence of TBS clinical validation.
  • How TBS can be a significant aid to better characterize your patient’s risk profile.
  • Short grid to understand the risk of fracture based on a combined model of TBS and BMD.

Updated for TBS Osteo 3.1

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NIST Director Testifies Before House Science Subcommittee on Agency Reauthorization; Touts Success of the Manufacturing USA Program in Promoting Technology Transfer – ASME

Last Wednesday, the House Science Committee, Subcommittee on Research and Technology, invited Under Secretary of Commerce and Director of the National Institute of Standards and Technology (NIST) Dr. Walter Copan to testify before the Subcommittee on reauthorizing the agency. NIST was last authorized in 2016 as part of the American Innovation and Competitiveness Act. Director Copan’s testimony covered each of the technologies the Trump Administration is collectively referring to as “industries of the future,” including Quantum Information Science, Artificial Intelligence, 5G, Advanced Manufacturing, and Biotechnology. He specifically commented on how NIST catalyzes partnerships between industry, academia, government, and other organizations to promote U.S. innovation and economic competitiveness.

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Uniform nanoparticle vaccines

Precise loading of diverse peptides for vaccination is enabled by a strategy for peptide–TLR7/8 conjugate self-assembly of uniform nanoparticles. The approach is compatible with the development of personalized strategies, such as cancer vaccines targeting patient-specific neoepitopes.

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University of Maryland athletics announces spectator restrictions amid coronavirus outbreak – Baltimore Sun

University of Maryland athletics on Wednesday announced a series of safety measures for its home events amid concern over the coronavirus outbreak, now labeled a pandemic by the World Health Organization.

Among several changes announced in a release, “Effective immediately, only student-athletes, coaches, essential personnel, officials, credentialed media and a limited number of family members of the competing teams will be permitted to attend games, until at least April 10.”

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New Enterprise Associates Amasses $3.6 Billion for 17th Fund – WSJ

New Enterprise Associates has raised $3.6 billion for its 17th venture fund, the largest in the more than 42-year history of the firm.

NEA set out in the second quarter of 2019 to raise New Enterprise Associates 17 LP and held a final closing in February at its target, said General Partner Mohamad Makhzoumi.

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