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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 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:

• Collaborating for Growth in the BioHealth Capital Region
• International BioHealth Companies Entering the U.S. Market
• Advancing Your Technology Through Non-Diluted Grants
• Raising Early State Capital in Difficult Times

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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 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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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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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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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 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 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, 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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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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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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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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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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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 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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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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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 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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* 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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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, 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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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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<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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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., 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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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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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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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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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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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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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 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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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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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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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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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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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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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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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:

• Collaborating for Growth in the BioHealth Capital Region
• International Biohealth Companies Entering the U.S. Market
• Advancing Your Technology through Non-Dilutive Grants
• Raising Early Stage Capital in Difficult Times

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

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

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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 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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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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FDA Cleared Medical Device Improves Feeding Outcomes of Infants Born Prematurely

Olathe, KS and Rockville, MD, April 28, 2020—Innara Health, developer of the only FDA cleared medical device designed to improve the feeding outcomes of infants born prematurely, is partnering with BioHealth Innovation (BHI) to support the company’s plans for growth through greater market access and the development of NextGen technology.  Innara Health is dedicated to improving feeding outcomes for newborn and infants born prematurely.  “As we continue to expand our domestic footprint, we are very fortunate to call BHI our partner as their infrastructure and access will certainly support Innara in our journey to redesign the NTrainer, enter into adjacent markets, and expand globally” states Innara CEO Chris Mathia.  “We are excited to support Chris and his team as they expand, grow and develop new technology ultimately enabling many more NICU patients to return home to their families sooner and healthier” said BHI CEO Rich Bendis.

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Immunomic Therapeutics, Inc., (“ITI”) a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today the close of a $61.3M financing led by HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs. This represents the second closing in the investment process for the HLB Consortium, ($10M was placed in February 2020), and substantially increases their holding in Immunomic Therapeutics to 47.6% of the common stock. HLB also secured an option to make further investment into the company in the months ahead.

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Gentian AS, a Norwegian company, with its US office at BioHealth Innovation in Rockville, Maryland is seeking collaborators to investigate if two of the biomarkers in their portfolio, cystatin C (FDA510(k) cleared) and plasma calprotectin (US research only), could potentially be useful for detection of the severely affected COVID-19 patients.

High mortality and long hospitalization are consequences of the severe cases with COVID-19 pneumonia. Gentian therefore believes that it is important to identify biomarkers that can aid in early, rapid and effective identification of the severely affected patients.

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BALTIMORE, Md., April 27, 2020 /PRNewswire/ — LifeSprout, a privately-held regenerative medicine company founded with technology licensed from Johns Hopkins University, has closed a $28.5 million Series A financing. The company is using proceeds to support clinical development of novel therapeutic products from its Regenerative Matrix platform.

The financing was led by Redmile Group, LLC, with new institutional investors Nexus Management, LP, Emerald Development Managers, LP, and the Abell Foundation joining the syndicate.

“We are delighted to complement the lead investment from Redmile with a strong cadre of Maryland-based and international investors,” stated Sashank Reddy, MD, PhD, co-founder of LifeSprout. “The early, visionary investments made by the Maryland Stem Cell Research Fund and others made this new financing possible.”

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A Baltimore company will be at the forefront of producing a potential coronavirus vaccine.

Once a COVID-19 vaccine is ready for mass production, the company is going to be making hundreds of millions of them.

“We’ll be providing the drug substance manufacturing which is essentially the vaccine itself,” says Syed Husain, senior vice president of Emergent BioSolutions.

All of that work will happen at Emergent BioSolutions, which is located in front of Johns Hopkins Bayview.

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BALTIMORE–(BUSINESS WIRE)–Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, announced today that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio™ tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner. By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.

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REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today provided additional long-term data from the ongoing Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD).

“I am impressed by the overall outcomes in patients after a one-time administration of RGX-314. I believe that RGX-314 is the leading gene therapy program for a major retinal disease such as wet AMD and could be an important potential one-time treatment option for AMD patients who require frequent and burdensome anti-VEGF injections. Real-world evidence demonstrates that patients lose vision over time with our current standard of care and incur significant treatment burden with frequent clinic visits and injections,” said Allen C. Ho, M.D., Director of Retina Research at Wills Eye Hospital and Mid Atlantic Retina and investigator surgeon in the RGX-314 trial.

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Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.

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ANNAPOLIS, MD—After weeks of consulting with leading scientists, business leaders, and public health experts, Governor Larry Hogan today introduced the ‘Maryland Strong: Roadmap to Recovery,’ which provides a safe, effective, and gradual approach to reopening the state as it continues to combat the COVID-19 pandemic.

“As we begin to reopen, it will continue to be important for Marylanders, particularly older and more vulnerable Marylanders, to continue to stay home as much as they can,” said Governor Hogan. “All Marylanders should continue to avoid crowds and gatherings, and they should continue to practice physical distancing and to take precautions to protect themselves, their families, and their fellow Marylanders. Together, we are going to defeat this virus, and together, the State of Maryland will return stronger and better than ever.”

Image: https://governor.maryland.gov

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Maryland Gov. Larry Hogan on Friday announced his three-phase plan to eventually reopen the state amid the coronavirus pandemic.

Hogan called the plan a “well-thought-out, gradual, safe and effective path forward,” supported by four pillars he has spoken about often in recent weeks: increases in testing, personal protective equipment, contact tracing and hospital surge capacity.

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Emergex Vaccines Holding Limited (‘Emergex’), a biotechnology company developing CD8+ priming set-point vaccines to prevent serious infectious diseases, today announced that it has entered into an agreement with the George Mason University, based in Virginia, in the United States.

The agreement specifies that George Mason University’s National Center for Biodefense and Infectious Diseases will provide their unique expertise and resources as a partner in the development of Emergex’s vaccines against highly pathogenic RNA viruses. In particular, George Mason University’s Biosafety 3 capabilities, coupled with their experience in dealing with RNA viruses, means that they are a well-suited collaborator on the vaccine validation studies, as well as the optimization of vaccine design.

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The rapid growth of biopharma is causing a shift to a new paradigm for the drug development and delivery model. In the same manner that the personal computing industry grew and developed business models that fit the way products were sourced, constructed and delivered, a business model for biopharma is taking shape.

Image: https://www.biospace.com

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Johnson & Johnson (NYSE:JNJ) says it will work with Emergent BioSolutions (NYSE:EBS) to produce more than a billion doses of a COVID-19 vaccine candidate, as it seeks to scale up global manufacturing of its potential treatment.

J&J says it is already preparing for clinical vaccine production at its Leiden facility in the Netherlands, with the aim of starting its Phase 1 clinical trial of its vaccine candidate on humans in September and potentially having it ready under an emergency use authorization next year.

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In the coronavirus era, a host of epidemiological terms have entered common public use. There’s the now-ubiquitous “social distancing,” and the newly politicized “flatten the curve.” And as states and local governments seek a way out of lockdowns that have brought their economies to a near-standstill, “contact tracing” has made its way into everyday conversation as well.

Image: Public health nurse Lee Cherie Booth conducts a test for COVID-19 outside of the Salt Lake City Public Health Center on April 10, 2020, accompanied by Salt Lake County infectious disease nurse Travis Langston. When a swab test comes back positive, contact tracing starts. Scott G Winterton—The Deseret News via AP

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When a child gets seriously sick, it’s up to us to fight for the world that they believe in. Johnson & Johnson Innovation is at the forefront of that fight. Helping to build a better future for the next child battling cancer, fighting the flu or facing the need for surgery.

The JLABS @ Washington, DC Children’s QuickFire Challenge invites innovators to submit game changing ideas, technologies, and solutions that have the potential to impact pediatric oncology, pediatric surgery and influenza. The innovator(s) with the best idea(s) will be awarded up to $150,000 in total grant funding; one year of residency at JLABS @ Washington, DC with the use of a bench, workstation, and access to the JLABS @ Washington, DC community; and mentorship from experts at the Johnson & Johnson Family of Companies

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Maryland tech companies started the year bringing in a surge of venture capital funding, and three of the state’s top 10 deals were in Baltimore, according to data from the latest PwC/CB Insights MoneyTree report. But a downturn in the last two weeks as the COVID-19 pandemic-caused slowdown took hold is leaving reason to keep celebrations on lockdown for now.

The $227 million that 21 companies raised from investors was a 44% uptick from the $115 million in the fourth quarter of 2019.

Image: The Huntress team. (Courtesy photo)

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Just over three weeks ago the CARES Act, a massive piece of legislation designed to combat the economic havoc being wrought by the coronavirus pandemic, was enacted.

One significant piece of that legislation is the Paycheck Protection Program (PPP), which allows small businesses to borrow funds from the Small Business Administration and affiliated lenders roughly equivalent to 2.5 months of payroll costs. The use of borrowed funds is restricted to “payroll costs” (employee compensation, group health benefits, retirement benefits, state unemployment taxes), rent, mortgage interest, interest on other loans and utilities.

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Across the country, children’s hospitals are grappling with significant financial impacts due to the COVID-19 crisis. We are dealing with substantial decreases in revenue as well as increased expenses directly tied to addressing this global pandemic. Children’s National Hospital is losing $1 million a day. I had a chance to share our challenges with NBC News Reporter Josh Lederman and to spotlight some potential solutions. #covid19 #pediatrics #finances #federalfunding #healthcare #childrenshospital

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Working as an emergency and critical care physician at the University of Maryland School of Medicine, Dr. Steven Tropello is seeing the lack of protective equipment for medical workers up close.

One particular area is during a procedure in which a tube is inserted into a patient’s airway, called intubation. It’s necessary to place someone on a ventilator, but presents danger of spreading the new coronavirus through the air or touch to doctors if they lack protection.

Image: CareCove. (Courtesy photo)

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Most Americans are still stuck at home, but a trio of reports, out from Harvard, Johns Hopkins, and former US Food and Drug Administration Commissioner Scott Gottlieb, are starting to lay a foundation for what reopening the country might look like, if done safely.

Though staying inside is certainly keeping more infections at bay right now, it’s not without its costs.

Aside from the strain stay-at-home orders are putting on families, friends and communities, the newfound national quiet means the US is “hemorrhaging $100 billion to $350 billion a month,” according to the new Harvard analysis, which was released on Monday.

Image: A worker wears a protective face mask in a factory of roll-forming machine maker Gasparini, in Mirano. Reuters

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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and member of the White House Coronavirus Task Force, says “we are not in a situation where we can say we are exactly where we want to be with regard to testing” capacity for COVID-19 in the U.S.

Fauci, in a discussion for TIME 100 Talks: Finding Hope on Thursday, says that the U.S. needs to not only increase the number of tests, which is happening as commercial testing companies increase production and the Food and Drug Administration continues to clear tests using different types of samples (including ones from the nose and saliva, as well as blood). But, he says, we also needs to make sure tests can actually be run the way they should.

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Even prior to COVID-19, change was afoot in the venture capital industry. Machine learning and algorithms were emerging as new ways to spot winners, and cities like Boston staked out turf as VC hot spots, proving that not all innovation takes place in Silicon Valley.

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We at Gentian AS believe it is the duty of all companies in the health industry to help combat the ongoing pandemic of COVID-19/Corona virus. High mortality and long hospitalisation are the consequences of the severe cases with COVID-19 pneumonia. Hence, it is important to identify biomarkers that early could aid in rapid and effective identification of the severely affected patients. In the Gentian test portfolio, the two biomarkers, cystatin C and plasma calprotectin, could be useful for the early detection of the severely affected COVID-19 patients. To do our part we are reaching out to research/hospital institutions who want to run a trial to assess whether these biomarkers can make a contribution in the detection of severe COVID-19 cases.

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In a different year, incoming freshmen would already have in hand a tightly choreographed schedule for late summer and early fall: the move-in date, the orientation and, finally, the first day of classes.

But on the coronavirus pandemic calendar, there are no dates yet for the next academic year. Just scenarios. And that unprecedented uncertainty is fueling a second wave of crisis for schools already plunged into financial distress.

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Even as the novel coronavirus has derailed daily life and business operations, the life sciences sector continues to see companies make public debuts and ink both financing and partnership deals.

In venture capital, US deal activity in the first quarter tallied 2,300 financings totaling $34.2 billion, according to the latest report by the National Venture Capital Association, which uses data from PitchBook. That’s roughly on track to match the total raised in the past two years, both record-setters in one way or another. But the likelihood of that pace continuing is slim, according to the report.

Image: Sarah de Crescenzo

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