News Archive

Have you register for this year’s Women Building Bio event? The third Annual Women Building Bio Conference is taking place October 17 at the Inova Center for Personalized Health. This is a one-day regional conference converging extraordinary men and women, industry and academia, researchers and innovators, professionals and decision-makers gathering together to cultivate relationships and making an impact. Click here for the agenda and more information. (For a discount code, email BHI and register by 3 p.m., Tuesday, October 16th.)

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has completed its acquisition of PaxVax, a company focused on developing, manufacturing, and commercializing specialty vaccines that protect against existing and emerging infectious diseases. With the closing of this transaction, Emergent acquires two marketed vaccines – Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the U.S. Food and Drug Administration (FDA) for the prevention of typhoid fever, and Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera, a potentially serious intestinal disease, caused by Vibrio cholerae serogroup O1. The acquisition broadens the company’s development pipeline with vaccines that address adenovirus types 4 and 7, which are common causes of acute respiratory disease, and chikungunya, a viral disease spread to humans by infected mosquitoes that can cause severely debilitating joint pain. The acquisition also expands the company’s sales capabilities with a global specialty salesforce and marketing and distribution partners focused on the travelers’ market and establishes an international manufacturing footprint with European-based cGMP biologics facilities.

Pharma major Lupin announced that it has received tentative approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals Inc.’s (Sunovion) Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.

Lupin’s Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg is the generic version of Sunovion’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.

The Food and Drug Administration approved or tentatively approved a record-setting 971 generic drugs in fiscal year 2018 that ended last month, the agency announced on Thursday.

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) has been renewed for funding under a cooperative agreement grant from the U.S. Food and Drug Administration (FDA). A collaborative partnership led by James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy, and William E. Bentley, PhD, the Robert E. Fischell Distinguished Chair of Engineering at the University of Maryland, College Park (UMCP), M-CERSI is one of only four FDA-funded CERSIs in the U.S., and the only CERSI to receive continuous funding from the FDA since it first launched in 2011. This latest renewal, which allows for up to $5 million per year over five years, will allow M-CERSI to continue its mission to contribute to modernizing and improving the ways in which drugs and medical devices are reviewed and evaluated.

Montgomery County is proving to be a premium address for the growing biotechnology sector. 

The BioHealth Capital Region, which includes Maryland, Virginia and Washington D.C., is ranked No. 4 on the 2018 list of top biopharma centers by Genetic Engineering & Biotechnology News (GEN). The cluster moves up from a No. 5 ranking in 2017.

GEN ranks regions nationally based on several factors, including National Institutes of Health (NIH) funding, venture capital investment, patents, lab space and jobs in biotech. 

Five consecutive quarters—and counting—of declining deal counts in pre-seed and seed-level investments for health technology startups in the U.S.

We’re thrilled to announce Molly McCartin, Partner, Drive Capital, will be a featured speaker at the Fall 2018 Inova Discovery Series!

Molly McCartin is an investing partner with a focus on healthcare at Drive Capital, a venture capital firm based in Columbus, OH founded by two former Sequoia partners. Molly started her career at JP Morgan Chase in Equity Research. She then moved to 7Wire Ventures investing in healthcare companies that empower the health consumer. Molly spent the last four years at Livongo Health, helping the company grow from 6 employees to over 150 and over 200 customers. Molly graduated from MIT with a degree in Applied Math and Economics.

It’s cybersecurity month at Technical.ly and this new accelerator program is here to heat up the discussion.

There are lessons for other industries in the way pharma companies use mergers to innovate, work more efficiently, and bolster product portfolios.