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More than 50 local leaders have mapped out an economic recovery strategy for the Washington area that they say would leave it more unified, resilient and prosperous than before the novel coronavirus upended the region.

Connected DMV — a group representing the local academic, nonprofit, public and private sectors — initially came together in March 2019 to drive economic growth in the D.C. area. When the pandemic struck a year later, the group pivoted to creating what it calls a “strategic renewal” task force, which issued a report this month with 12 initiatives to remedy the region’s social and economic challenges.

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RICHMOND, Va.–(BUSINESS WIRE)–Governor Northam and the Virginia Biotechnology Association announced today that GO Virginia has approved a competitive grant request to help fund Virginia Bio-Connect, a $3.2 million Statewide industry cluster scale up initiative. The project, directed by the Virginia Biotechnology Association, is a multi-regional collaboration designed to increase connectivity and awareness of the existing programs, resources, and communities in the Commonwealth that support the life sciences industry.

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ROCKVILLE, Md., Dec. 22, 2020 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD).

At a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale (AISRS). In addition to meeting the primary efficacy endpoint, the Phase III study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week 6. The active dose was well tolerated.

SPN-812 is under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in pediatric patients 6 to 17 years of age. As announced in November, 2020, the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients to indicate that the review cycle for the application was complete and that the application is not ready for approval in its present form. The Company will be meeting with the FDA in January 2021 to discuss the CRL. Assuming approval for pediatrics, the Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in the second half of 2021.

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ROCKVILLE, Md., Dec. 22, 2020 /PRNewswire/ — 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 announced that it has entered into an agreement to sell a portion of the royalty rights due to REGENXBIO from Novartis Gene Therapies from the net sales of Zolgensma® to entities managed by Healthcare Royalty Management, LLC (HCR) for a gross purchase price of $200 million. This transaction provides immediate, non-dilutive capital to REGENXBIO for continued innovation in the development of potential breakthrough gene therapies for patients and completion of its internal manufacturing capabilities.

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GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.

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The U.S. Food and Drug Administration (FDA) has approved the second-ever genetically modified subtype of pig for human consumption. But there are no plans to raise this pig for meat or other foodstuffs—the use case is actually much, much cooler.

Get unlimited access to the weird world of Pop Mech. LET’S GET WEIRD. By adjusting the pig’s genes so it doesn’t produce a particular sugar called galactose-alpha-1,3-galactose (alpha-gal), scientists can make medicines that are safe for a group of people who suffer from a peculiar, little-understood allergy. And while this certification isn’t planned for meat, that could be next.

Image: TIM MACPHERSON

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Advances in technology that shape the future come in different forms. Some help us realize possibilities of systems that already exist. Others allow us to reframe what’s possible.

Take computing, for instance. Advances in transistors over time have produced more powerful processors that can fit into ever smaller and more affordable packages. This has made it possible to do computing tasks more efficiently and conveniently, but in the end these improvements apply the same principles of classical computing that were used when there were room-sized mainframes.

Image: Sarah Kreikemeier tunes an optical assembly at IonQ’s offices. (Photo courtesy IonQ/Erin Scott)

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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.

Image: https://biobuzz.io

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SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.

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A biotechnology company whose research and intellectual property has helped to create the Oxford-AstraZeneca Covid vaccine has raised new investment from venture capitalists.

Oxford-based Vaccitech has agreed the funds – understood to be as much as £10million – from Future Planet Capital which also invests in health, climate change and education projects.

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BALTIMORE (WJZ) — A team from Johns Hopkins University won a global mask design challenge.

Two dozen undergraduates from the university make up Team Polair. Together, they created a clear mask they said people would want to wear.

Image: https://baltimore.cbslocal.com

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Nanochon is aiming to close the round in January to fund the first human study of its product.

Image: Ben Holmes is co-founder and CEO of Nanochon. COURTESY BEN HOLMES

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The latest on the innovations that will let us go back to normal. This has been a devastating year. More than 1.6 million people have died in the COVID-19 pandemic, with more than 75 million cases and tens of trillions of dollars in economic damages. Millions of people are out of work and struggling to pay their bills, and more than a billion children are missing out on crucial time in school. In the U.S., this year also saw the horrifying killings of George Floyd and Breonna Taylor, ruinous wildfires, and a presidential election unlike any other in modern times.

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It’s tempting to look forward to the new year — especially after such an abysmal 2020 for so many.

But before we do, let’s not forget all that happened in the region’s innovation ecosystem this year. It wasn’t all bad.

Here, we recap some of the top trends, events and topics over the last 12 months.

Image: Husband-wife co-founders Matthew and Marnel Goins run Puzzle Huddle, which saw increased demand amid stay-at-home orders, school closures and the refocus on supporting Black-owned businesses. Puzzle Huddle

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BioTalk Media Award-Winning Podcast BioTalk Welcomes Dr. James Crowe, Director, Vanderbilt Vaccine Center, Professor, Pediatrics and Pathology, Microbiology and Immunology, Ann Scott Carell Chair and Founder of ID Biologics.

Listen now on Apple http://apple.co/34u0kz6, Google http://bit.ly/38jfE2I, Spotify http://spoti.fi/3pddVme, and TuneIn http://bit.ly/37D2M8z.

His laboratory has a broad portfolio of work in the area of viral immunology and antibody sciences, with the goal to discover mechanisms of immunity important to developing new therapeutics and vaccines.

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BHI’s Managing Director, Economic Development, Judy Costello was recognized by voters in the 1st Annual BioBuzz awards this past week as the top Community Builder in the BioHealth Capital Region.  This award honors someone in the region who has gone above and beyond their responsibilities to make an impact on the ecosystem by being a thoughtful community builder who fosters intentional collaborations and meaningful contributions of their time, energy, and expertise to support the biohealth community. This person is a servant leader who sees beyond their job description or the balance sheet and strives to create a rising tide for all across the BioHealth Capital Region so that we can collectively make a greater impact on public health and patients around the world.

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The BioTalk with Rich Bedis Podcast created by the BHI President & CEO and Andy Eckert was awarded the 1st Annual BioBuzz Media Award. This award honors a media campaign that most aligns with our mission; ‘to create exceptional experiences that better connect people and employers and foster a stronger regional ecosystem.’ At its core, it recognizes the media campaigns or platforms that have successfully engaged, informed, and connected people and reflect favorably on the BHCR. Eligible nominations may include social media, podcasts, video series, blog series, event or webinar series, and other advertising, marketing, and public relations campaigns.

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Qiagen North American Holdings has announced plans to renovate and expand its U.S. headquarters and R&D and manufacturing facility in Montgomery County, Md.

More specifically, Qiagen plans to renovate its 146,000-square-foot facility at 19300 Germantown Road in Germantown, Md., to accommodate expanded production of testing products for COVID-19 and other diseases, as well as lease additional space in the area.

Image: Image by DarkoStojanovic via Pixabay.com

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“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features 5 Questions with Brian Darmody, CEO, Association of University Research Parks (AURP).

Brian Darmody is CEO of AURP, a global nonprofit representing research parks and innovation districts sponsored by universities, federal labs, communities, hospitals, and other institutions in the US and 12 other countries.

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The 20-year-old company’s first product tackles certain breast cancers.

Image: Dr. Scott Koenig is president and CEO of Rockville biotech MacroGenics. JOANNE S. LAWTON

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ROCKVILLE, MD, Dec. 18, 2020 (GLOBE NEWSWIRE) —

MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, announced today a research collaboration and global license agreement to develop a preclinical bispecific molecule with Janssen Biotech, Inc. The research collaboration will incorporate MacroGenics’ proprietary DART® platform to enable simultaneous targeting of two undisclosed targets in a therapeutic area outside oncology.

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Sykesville, MD, and Fairfax, VA, December 21, 2020 – Noble Life Sciences (NLS), a preclinical contract research organization located in Sykesville, MD, has signed a Collaboration Agreement with George Mason University (Mason) to access the National Center for Biodefense and Infectious Diseases (NCBID) BSL-3 facility located within their Biomedical Research Laboratory at Mason’s Science and Technology Campus in Manassas. The Agreement enables NLS to perform federal and non-federally funded BSL-3 animal model projects to support the development of new antiviral and antibacterial agents against infectious and resistant pathogens.

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The hemafuse set contains a big syringe, which acts as the collection barrel, a nozzle connected to a filter on the syringe pulls the blood in while sieving the clots.

With a push, the blood is redirected through another tube, connected to the same syringe and operated by a stopcock, to the blood bag for transfusion back to the patient.

Image: Dr Gerald Osei-Owusu with the hemafuse medical device – https://dailyguidenetwork.com

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RICHMOND, VA. (December 16, 2020) ‐ BRAINBox Solutions today announced it is beginning enrollment in its pivotal clinical trial, HeadSMART II (Head injury Serum markers and Multi-modalities for Assessing Response to Trauma), of the company’s concussion diagnostic and prognostic test, BRAINBox TBI. The multi-national, multi-site trial, which will enroll up to 2,000 patients, aims to generate data to support an application for regulatory clearance by the U.S. FDA.

The BRAINBox TBI (Traumatic Brain Injury) test will be the first objective test designed to assist in the diagnosis of concussion and provide an assessment of the risk of chronic injury. The FDA has granted the test Breakthrough Device designation.

“We do not have a validated objective method to determine an early TBI diagnosis. While a head CT identifies anatomic abnormality, it does not predict post-concussive symptoms or disability at the time when interventions change outcomes. We need an early objective test,” said W. Franklin Peacock MD FACEP, the Principal Investigator of the study. Dr. Peacock is Professor of Emergency Medicine and Vice Chair for Research in the Department of Emergency Medicine at Baylor College of Medicine.

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As health agencies across the US rush to distribute the first round of COVID-19 vaccines, a new online tool aims to track their progress.

A dashboard hosted by Johns Hopkins University shows how many doses of COVID-19 vaccines have been administered across the US, according to publicly available data published by state health agencies and aggregated by the Centers for Civic Impact.

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GlaxoSmithKline is stumping up $85 million upfront and up to an extra $730 million in biobucks for Surface Oncology’s early-stage antibody asset.

The drug the U.K. pharma is betting on, known as SRF813, is a fully human, IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells and T cells.

In preclinical tests, Surface Oncology says, SRF813 has shown the “potential to elicit a strong anti-tumor response and promote immunological memory.” It’s still only in IND-enabling studies, but the company has an IND planned for next year.

Image: (GlaxoSmithKline)

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Work on the $5.5 billion project has been at a standstill since April due to the Covid-19 pandemic.

Image: Work on the $5.5 billion redevelopment at Port Covington was shut down in April amid the Covid-19 pandemic. Developer Marc Weller previously said it would not resume until the TIF bonds were sold. MELODY SIMMONS

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BALTIMORE — The Maryland Department of Commerce is partnering with the Maryland Business Innovation Association to launch the Maryland Business Innovation Challenge, a program aimed at bringing together the state’s corporate community with local innovators to solve real-time business challenges.

Image: https://www.myeasternshoremd.com

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AstraZeneca on Saturday said it was acquiring Alexion Pharmaceuticals for $39 billion, marking a significant expansion into the treatment of rare diseases of the immune system.

The deal — a mix of cash and stock — values Alexion at $175 per share, a 45% premium to Friday’s closing stock price.

Image: KRISTOFFER TRIPPLAAR/SIPA/AP

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National Institute of Standards and Technology (NIST) researchers are working to reduce the uncertainty associated with climate-change measurements using a mobile temperature-sensing technology made for tracking delicate or perishable, high-value packages in transit. Developed by international shipper FedEx and tested with help from NIST, the device connects to cell phone networks to provide users with near real-time information on the package’s precise location, temperature, humidity, pressure, acceleration, elevation and exposure to light.

Image: Credit: Strouse/NIST Developed by international shipper FedEx and tested with help from NIST, the Senseaware device connects to cell phone networks to provide users with near real-time information on a packages precise location, temperature, humidity, pressure, acceleration, elevation and exposure to light. NIST researchers plan to deploy the technology as part of a pilot project to monitor and improve climate measurements.

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The US Food and Drug Administration said Monday it has approved a genetically modified pig whose body doesn’t make a component that can trigger allergies in people.

The pigs should produce meat that is safe to eat, and organs and tissues safe for transplants and for the other biomedical uses for people allergic to the compound — a sugar found on the surface of animal cells known as alpha-gal, the FDA said.

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Celebrating 20 years of supporting women-led companies and industry transformation, Springboard Enterprises announces Natalie Buford-Young as its first CEO. Buford-Young will work alongside Springboard President and co-founder Amy Millman, broadening the breadth and depth of the organization.

To date, Springboard’s portfolio numbers 819 women-led companies, which have created $27.2 Billion in value.

In her role, Buford-Young will be responsible for leading Springboard’s mission to accelerate the growth of entrepreneurial companies led by women through access to essential resources and a global community of experts. An accomplished and innovative corporate executive, entrepreneur, and community builder, Buford-Young joins from Deloitte, where she served as Managing Director of Market Development for Deloitte’s venture capital, private equity and emerging private company practices.

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Philanthropist and author MacKenzie Scott is donating tens of millions of dollars to historically black universities in Maryland.

The Baltimore Sun reported Tuesday that the schools are Morgan State, Bowie State and the University of Maryland Eastern Shore.

Image: As shipments of Moderna’s vaccine begin, health officials warn the public not to get complacent. News4’s Darcy Spencer has the warning from a local doctor about Christmas travel and gatherings. – https://www.nbcwashington.com

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In the Spring of 2020, members from seven university tech transfer offices met with partners from six venture capital firms to discuss challenges both parties routinely face when working on life science deals together. Below is the resulting set of best practices, meant to benefit universities and VCs more broadly. Individuals interested in sharing feedback on the below guidelines should contact techventures@columbia.edu and include their name, organization, and work email. Please note that not all of these recommendations may be appropriate for startups outside of the life sciences. Comments and feedback will be posted at the bottom of this page.

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