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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.

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.

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.”  

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.

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.

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.

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.