BioHealth Innovation Weekly for June 25, 2024

Join us for a compelling episode of BioTalk with Rich Bendis as we welcome Dr. Michelle E. Tarver, Deputy Center Director and Chief Transformation Officer at the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA). With a distinguished background as a board-certified ophthalmologist and epidemiologist, Dr. Tarver is at the forefront of transforming the evaluation and inclusion of medical devices in underserved and underrepresented populations.

In this episode, Dr. Tarver introduces the FDA and the CDRH Division, explaining the definition of a medical device by FDA standards. She discusses the creation of the Chief Transformation Officer role within the FDA, highlighting its importance and the strategic vision behind it.

Listen now via your favorite podcast platforms.

Apple: https://apple.co/3VFF5UK
Spotify: https://spoti.fi/3RC9sug
Amazon Music: https://amzn.to/4cdYqn8
TuneIn: https://bit.ly/4czGVO0

We explore the critical importance of diversity, equity, and inclusion (DEI) in evaluating medical devices, and how these efforts are essential for ensuring equitable healthcare for all. Dr. Tarver introduces the innovative “Home as a Health Care Hub” initiative by the FDA/CDRH, explaining its potential to revolutionize healthcare delivery.

GAITHERSBURG, Md., June 20, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that it has entered into a definitive agreement to sell its drug product facility in Baltimore-Camden to an affiliate of Bora Pharmaceuticals Co., Ltd. (“Bora”, TWSE: 6472), a leading international pharmaceutical services company, for a total value of approximately $30 million. The Camden site, which is part of Emergent’s Contract Development and Manufacturing Organization (CDMO), has clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services. Alongside the facility, approximately 350 current Emergent employees are expected to join Bora as part of the transaction.

ROCKVILLE, Md. and SUZHOU, China, June 20, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that the agreed equity investment by Takeda has been closed on June 20, 2024, with all proceeds already received. Pursuant to the terms of the Agreement, Ascentage Pharma has allotted and issued an aggregate of 24,307,322 subscription shares to Takeda International at the share purchase price of HK$24.09850 (equivalent to approximately US$3.08549).

WASHINGTON, June 13, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that it has received a revised unsolicited proposal from Future Pak, LLC ("FP") to acquire Vanda for $8.50-$9.00 per share in cash plus certain Contingent Value Rights.

Consistent with its fiduciary duties, and in consultation with its financial and legal advisors, Vanda's Board will carefully review and evaluate the revised, non-binding proposal to determine the course of action that it believes is in the best interests of the Company and its shareholders.

Ianne Salvosa June 18, 2024 - Efforts are afoot to make Richmond more of a player in the biohealth industry.

Downtown-based Activation Capital is launching the Frontier BioHealth program to provide training and mentorship for up to 10 startups from August to November to groom life sciences companies in the area for the long term.

Activation Capital Vice President of Entrepreneurship Jim Pannucci said the program is a nod to the group’s original mission to help the region and the VA Bio+Tech Park be a hub of biotechnology. Activation Capital operates the park, while supporting entrepreneurship and startups in the region through various programs.

The Bio+Tech Park was established about three decades ago to turn Richmond into a center of biotechnology and now about 70 companies and research facilities operate in the area, with interests ranging from smoke-free tobacco alternatives to organ donation.

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Let BHI be your trusted partner in navigating the funding landscape and unlocking the full potential of your groundbreaking work. If you're seeking assistance, don't hesitate to reach out to Jon NelsonatJNelson@BioHealthInnovation.org.