FSIF COVID PRESS RELEASE 06 15 20 pdf 1 page

<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:

Ampel Bio Solutions, LLC

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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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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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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 This email address is being protected from spambots. You need JavaScript enabled to view it.

 
Novavax Logo

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.

 

AstraZeneca Logo

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.

 

Pfizer

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.”

 

altimmune logo

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.

 

Concept Of Covid 19 In Red Background Free Stock Photo

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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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.

Jay A. Perman

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.

 

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

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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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)

Emergent Logo

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.

 

Novavax Logo

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.

 

Banners and Alerts and 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

Creatv BIO Logo

ROCKVILLE, Md.--(BUSINESS WIRE)--Creatv MicroTech, a privately-held biotechnology company has pioneered a blood test for the universal screening of early stage cancer. They will present their initial clinical data showing the ability to identify invasive cancer with 87% accuracy. “We are delighted to present results from a training set of 10 different types of cancers,” said Dr. Cha-Mei Tang, Chief Executive Officer of Creatv. “The data shows that we obtained 85% sensitivity for all cancers (from 79% of patients in Stage I and increasing to 95% of patients in Stage IV), and also shows 100% specificity when tested against healthy normal controls. This represents a significant step towards pan cancer screening by a routine blood draw with high sensitivity and specificity.”

 

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ROCKVILLE, Md., Feb. 11, 2020 /PRNewswire/ -- The Institute for Bioscience and Biotechnology Research (IBBR) is accepting proposals to lease a bio-manufacturing facility configured to produce biologicals under cGMP conditions in compliance with FDA requirements for phase I/II clinical trials. The facility is also equipped to perform process development research, pre-clinical manufacturing for material necessary to conduct IND-enabling toxicology studies, proof of concept (POC) studies, and process demonstration in advance of Good Manufacturing Practices (GMP) manufacturing. IBBR is a joint research enterprise between the University of Maryland and the National Institute of Standards and Technology (NIST).

Image: IBBR is strategically located in Rockville, MD within easy reach of major academic, industry, and federal research laboratories, including the University of Maryland campuses, NIST, NIH, FDA, NCI, and USDA. By Institute for Bioscience and Biotechnology Research

Banners and Alerts and 3 Roundcube Webmail Inbox

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.

Banners and Alerts and 3 Roundcube Webmail Inbox

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 Biosciences, Inc., and Ashvattha Therapeutics, Inc.

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The University System of Maryland (USM) Maryland Momentum Fund has invested $150,000 in College Park, Md.-based pathOtrak, a company that has developed a rapid food test for salmonella and E. coli in food.

The investment closes out pathOtrak’s $1.2 million seed round, along with a $200,000 investment from a global life sciences company with a food safety division and $310,000 from the Dingman Center Angels.

The Momentum Fund continues to invest in companies affiliated with the USM despite the COVID-19 pandemic and encourages applications through the Fund website at https://momentum.usmd.edu.

 

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It may not be quite business as usual as the state reopens and a new sense of normal takes shape amidst the COVID-19 pandemic, but a business accelerator program is pivoting to the health industry and University of Virginia students are testing out an app that could bolster contact tracing. 

Lighthouse Labs RVA, a Richmond-based accelerator program, is seeking applications for its Fall 2020 cohort. The program, which occurs twice a year, is a three-month intensive where seed-stage startups receive investment and mentoring. This cohort will place a focus on health through a partnership with the Health Innovation Consortium.

Image: Credit: Mike Kropf / Charlottesville Tomorrow

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In a bid to boost its global vaccine manufacturing abilities, Gaithersburg biotechnology firm Novavax has paid roughly $167 million to buy a biologics manufacturing plant in the Czech Republic.

The company paid cash for Praha Vaccines a.s., part of the Cyrus Poonawalla Group.

Novavax expects its newly acquired plant in Bohumil, Czech Republic to provide an annual capacity of over 1 billion doses of antigen for its COVID-19 vaccine candidate starting in 2021.

Image: In this photo released by Nucleus Network/ABC, technicians prepare for a clinical trial of a coronavirus vaccine in Melbourne, Australia, Tuesday, May 26, 2020, with hopes of releasing a proven vaccine this year. Novavax will inject 131 volunteers in the first phase of the trial testing the safety of the vaccine and looking for signs of its effectiveness. (Patrick Rocca/Nucleus Network/ABC via AP)

Queer 50 Martine Rothblatt

In 2013, Martine Rothblatt made $38 million, making her the highest-paid female CEO in the country at the time. Though Rothblatt told New York magazine that topping the list was like “winning the lottery,” it didn’t quite sit right with her. “I can’t claim that what I have achieved is equivalent to what a woman has achieved,” she said at the time. “For the first half of my life, I was male.”

Image: https://www.fastcompany.com

Morgan Eichensehr

Johns Hopkins spinout Personal Genome Diagnostics Inc. is looking to raise up to $3.5 million in new funding in support of its push to commercialize its cancer diagnostic technology.

Canton-based PGDx has already raised $2.7 million in the new round of debt and security financing, according to documents filed with the U.S. Securities and Exchange Commission. CEO Megan Bailey said the new funding comes from existing investors. The company is previously backed by about $147 million and its recent backers include Innovatus Capital Partners, Bristol-Myers Squibb, Cowin Capital, Helsinn Investment Fund, Inova Health System, Windham Venture Partners, as well as Maryland Venture Partners, New Enterprise Associates and Camden Partners.

 

Novavax Logo

GAITHERSBURG, Md., May 27, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the acquisition of Praha Vaccines a.s., part of the Cyrus Poonawalla Group, in an all cash transaction of approximately $167 million. The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic. The facility is expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021 for 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.

 

NIIMBL Logo

NEWARK, Del., May 26, 2020 /PRNewswire/ -- Today, the National Institute for Innovation in Biopharmaceutical Manufacturing (NIIMBL) announces that they have received $8.9 million from the U.S. Department of Commerce's National Institute of Standards and Technology (NIST). This award will fund high-impact projects that will support the nation's response to the COVID-19 pandemic. The funding is part of the first round of funding made available to NIST through the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

 

Matthias Evers

Imagine a world in which we can produce meat without animals, cure previously incurable diseases by editing the genetic fabric of an individual, and make industrial chemicals in yeast factories. The foundational technologies that could make all this possible largely exist. This is a Bio Revolution that could transform economies, societies, and our lives—and is already helping to respond to the COVID-19 pandemic.

 

Montgomery County Maryland

Montgomery County Executive Marc Elrich and County Health Officer Dr. Travis Gayles today announced critical benchmarks to reduce the spread of COVID-19 have been achieved, allowing the County to begin a gradual reopening. Phase I will start this Monday, June 1 at 6 a.m. The County plans for an incremental reopening, based on public health data. 

Image: https://www2.montgomerycountymd.gov

emergent biosolutions

GAITHERSBURG, Md., June 01, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has been issued a task order under an existing contract with 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), to deploy its contract development and manufacturing (CDMO) capacities, capabilities, and expertise to support the U.S. government’s efforts to accelerate delivery of COVID-19 vaccines.

“Emergent is proud of this expanded BARDA partnership that symbolizes confidence in our development and manufacturing capabilities that have served the U.S. government’s needs for more than two decades,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “Our longstanding record of delivering safe and effective medical countermeasures for public health positions us to continue to help at this critical moment by advancing COVID-19 vaccine programs of our fellow innovators in the industry.”