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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

Cursor and Biotech Showcase™ Investor conference Co produced by Demy Colton and EBD Group

We are now only a few weeks out from Biotech Showcase and excited to launch the Spotlight Sessions on our on-demand hub on partneringONE.

We have also posted several Digital Medicine and Medtech Showcase sessions this week. Sponsor Insight content, on-demand public and private company presentations as well as Investor strategy videos are available for you to watch on demand.

Be sure to look at the sessions we have planned for the weeks of January 5 and 11.

James Crowe AND Rich Bendis

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.

Mark pictures.. before and after the weightloss

I’ve been reluctant to write this blog post because historically I don’t like talking about weight. But I’ve been promising to publish how I lost 65 pounds in the past 18 months without any fad diets or gimmicks to try and be helpful to others. I have a plan,

I know it works and for the friends and family who have followed what I’ve done they’ve equally lost a lot of weight.

 

Washington Memorial from the Steps of the Lincoln Memorial.

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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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.

 

Sarah Kreikemeier tunes an optical assembly at IonQ's offices.

(Photo courtesy IonQ/Erin Scott)

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)

united therapeutics corporation logo

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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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

Covid 19 Vaccine

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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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.

 

Gates Notes Cover Image from Linkedin

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.

 

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

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

James Crowe AND Rich Bendis

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.

Judy Costello

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.

BIoTalk Logo

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

Brian Darmody

“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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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.

johns hopkins logo Google Search

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.

 

(GlaxoSmithKline)

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

KRISTOFFER TRIPPLAAR/SIPA/AP

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

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.

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.

United Therapeutics Logo

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