469th Edition, August 17, 2021

August 11, 2021 (Washington, D.C.) – A bold new public-private partnership to prevent future viral outbreaks from becoming pandemics has moved one step closer to realization, as the Greater Washington cross-sector nonprofit, Connected DMV, has announced the formal launch of a Global Pandemic Prevention and Biodefense Center (GPPBC). The Center will serve as a vehicle to foster greater collaboration among pandemic prevention stakeholders to deliver on strategic projects needed to advance pandemic preparedness and avoidance. The signature initiative of the Center accelerates the development of human monoclonal antibodies (mAbs) to treat the world’s top 100 pathogens across 25 pathogen families most likely to result in disease outbreaks.

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In this episode of #ThisIsUSG, BioHealth Innovation President and CEO Rich Bendis joins Dr. Anne Khademian for a discussion about BioHealth Innovation’s role in advancing the biotechnology/life sciences industry in Montgomery County and the capital region as a whole.

https://www.youtube.com/watch?v=0pe8g47_f-o

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RIVERDALE, Md., Aug. 12, 2021 /PRNewswire/ — Medcura, Inc., a commercial-stage medical device company, today announced it has raised $7.4 million in private equity to support its growing product line and development of its lead surgical candidate for clinical evaluation. The financing includes the sale of Series A Preferred stock as well as common stock based, in part, from certain investors benefitting from a Maryland Investment Incentive Program.

“Medcura has reached a pivotal point in our growth,” said Larry Tiffany, CEO of Medcura. “Our products are positively impacting the lives of patients and our community. With these funds we can accelerate product development, expand our commercial footprint and bring the company’s potentially lifesaving technology to operating rooms and battlefields worldwide.”

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On August 6th, 2021, FDA released an update on various matters related to COVID-19. Among these topics was an update on Emergent BioSolutions, a manufacturer who has come under fire for their mishandling production of COVID-19 vaccines.

However, FDA has now approved certain lots of the AstraZeneca vaccine made at the facility suitable for export. While the AstraZeneca vaccine is not approved for use within the United States, it is used by various countries overseas.

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HILDEN, Germany & WALTHAM, Mass. & GERMANTOWN, Md.–(BUSINESS WIRE)–QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) and OncXerna Therapeutics, Inc. (“OncXerna”), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, today announced signing a master companion diagnostics (CDx) agreement to develop a NGS CDx for OncXerna’s product candidate, Navicixizumab, and a non-exclusive license to the Xerna™ TME panel.

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One of the top questions that employers in the Life Sciences community within the Capital Region are asking is how companies are approaching bringing employees back to the office. That’s why we asked nearly 30 top employers in the area to share their strategies in a recent survey conducted by BioBuzz Media.

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Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

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Jeff Galvin, CEO of American Gene Technologies and Rich Bendis, CEO and President of BioHealth Innovation, Inc. have a fireside chat about the rapid evolution of the BioHealth Capital Region.

On the heels of Silicon Valley’s branding as one of the world’s largest tech hubs, the BioHealth Capital Region aims to brand the DMV region as one of the most prominent BioHealth clusters in the Mid-Atlantic. BioHealth Innovation, Inc. was founded 11 years ago in an effort to drive ideas from labs into markets through innovation-driven economic development organizations and initiatives.

Galvin and Bendis discuss the abundance of opportunities for growth within the region as it is home to a wide variety of research institutions, top scientists, and annual grants. Additionally, they discuss how BioHealth Innovation, Inc. cultivates success for companies within the competitive region.

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Brand new office / lab suites. Flexible suites that can be combined for larger uses. Full third floor available for customization.

Approximately 47,000 BRSF.

Click here to download a brochure.

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OVERVIEW:

• Free, half-day virtual event.
• Hear from inventors from the National Cancer Institute and the Frederick National Laboratory about technologies primed for commercialization and/or collaboration; great opportunity for biotech stakeholders and companies of all sizes, including start-ups.
• Panel sessions focused on technology commercialization.
• Lightning Pitch & Poster Session highlighting additional NIH technologies available for licensing and collaborative development presented by the NCI Technology Transfer Ambassadors Program.

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As a trifecta of crises upended life in 2020, the need for a diverse scientific and medical community grew ever more clear. George Floyd’s murder elicited worldwide protests against racial injustice. COVID-19 affected all of our lives and had an outsize impact on Black and brown communities. And COVID-19’s economic fallout only exacerbated extreme wealth inequality.

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We’re taking a closer look at each of the 50 winners of our 2021 Inno on Fire honorees.

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Starting in 2022, drugmakers filing new drug applications with clinical data will have to pay the FDA $3.1 million.

The FDA’s fee for new drugs with clinical data has risen from a little more than $2 million in 2017 to $3.1 million in 2022.

The 2022 fee for FDA approval applications not requiring clinical data will be about $1.6 million in 2022, which is about $200,000 more than the previous two years.

Drugmakers pay these fees to ensure the FDA responds to applications within 10 months for standard applications and within six months for expedited reviews.

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FZata, Inc. is developing our ground-breaking “Live Biologics In A Pill” platform for oral delivery of live biologics. Live Biologics In A Pill will open up a new route of oral administration for innovative live biologic therapeutics. FZata is pleased to announce that our lead drug, FZ002, has advanced to manufacturing stage and IND-enabling studies. FZ002 is a first-in-class live biotherapeutic product (LBP) yeast for the treatment of Clostridioides difficile (C. diff) infection. C. diff bacteria can cause life-threatening diarrhea. Infections occur most often in people who have taken antibiotics for other conditions. It is the most common healthcare-associated infection and the CDC has labeled it at the highest urgent threat level.

Image: https://biobuzz.io

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Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0642). Do not return the completed form to this address.

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This is what it is ALL about – the largest 3D printed hydrogel. This lung model can be perfused and ventilated and this blueprint replicates the entire conducting airway and large vasculature of the lung. Blueprint by Gregory Hurst. BioInk Formulation by Aman Kaur. Huge #DreamTeam Effort!

Looking to be on one of UT’s dream teams? Look no further: https://bit.ly/2QIqx6m

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