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June 25, 2024

Transforming Healthcare: The FDA’s Dr. Michelle Tarver on New Initiatives and the Future of Medical Devices on the BioTalk Podcast 

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.

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Emergent BioSolutions Announces Sale of Baltimore-Camden Manufacturing Site to Bora Pharmaceuticals for $30 Million

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.

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Ascentage Pharma Announces Closing of US$75 Million Equity Investment by Takeda

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).

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REGENXBIO Announces Expansion of AFFINITY DUCHENNE® Trial to Include a New Cohort of Younger Patients

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.

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RichmondBizSense: Life sciences startup support program looks to boost biohealth industry in Richmond

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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Unlock Your Innovation Potential with BioHealth Innovation's Grant Mapping Services

Navigating the complex landscape of non-dilutive funding can be daunting for many innovators and researchers. Identifying suitable grants that align with specific project goals is often challenging, requiring a deep understanding of the funding landscape and specific program criteria.

We recognize these challenges at BioHealth Innovation (BHI) and are committed to supporting your journey. Our comprehensive grant mapping services are designed to pinpoint the most relevant funding opportunities tailored to your unique needs. With our expert guidance, you can confidently navigate the intricate world of grants, ensuring that your projects receive the support they deserve.

In addition to our grant mapping services, BHI offers dedicated SBIR/STTR grant writing assistance. Our team of seasoned professionals will work closely with you to craft compelling grant proposals that stand out to funding agencies. We understand the nuances and expectations of these programs, which significantly enhances your chances of success.

Partner with BHI to leverage our expertise and maximize your chances of securing the right non-dilutive funding for your innovative projects. With our support, you can focus on what you do best—innovating and pushing the boundaries of biohealth and life sciences

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.

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