The US FDA is calling on its Vaccines and Related Biological Products Committee to weigh in on the causality of a higher rate of deaths and major cardiovascular adverse events among patients taking Dynavax Technologies Corp.'s hepatitis B vaccine Heplisav (rHBsAg-1018 ISS), as well as the adequacy company's proposed postmarketing safety to assess these risks.
Heplisav Vaccine Postmarketing Study Might Overcome FDA Safety Worries At Panel
Dynavax has already received two complete response letters for its hepatitis B vaccine; more patients who received Heplisav died or experienced cardiovascular events compared with the competitor arm.
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
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The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
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The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.
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The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.
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The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
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Two investigational products have made it onto the European Medicines Agency’s priority medicines scheme so far this year. Meanwhile, of the 14 products that entered the scheme last year, six were advanced therapies.