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Dynavax Hepatitis B Vaccine Could Get Comparative Post-Market Autoimmunity Assessment

 
• By Cathy Dombrowski

The observational study would look at Dynavax’s Heplisav and GlaxoSmithKline’s Energerix-B, according to FDA briefing materials for the Vaccines and Related Biological Products Advisory Committee’s Nov. 15 review of Heplisav for adults 18 to 70 years of age.

Members of FDA’s Vaccines and Related Biological Products Advisory Committee will weigh in Nov. 15 on whether a post-market observational study is sufficient to address lingering FDA concerns about the potential for autoimmune reactions to Heplisav (rHBsAg-1018 ISS), the hepatitis B vaccine from Dynavax Technologies Corp. that contains a novel adjuvant.

FDA did not formulate specific questions in its briefing materials for the panel, but rather said the meeting will focus on the adequacy of the safety and effectiveness data submitted...

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More from United States

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GLP-1 Pricing ‘Paradigm Shift’ Possible, But Would It Meet Trump’s MFN Goals?

 
• By Cathy Kelly

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• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

More from North America

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.