Chikungunya Vaccine Development May Rely On Immunologic Biomarkers Instead Of Traditional Trials

As the mosquito-borne chikungunya virus spreads into temperate regions worldwide, US FDA convenes advisory committee for an open discussion on development of vaccines.

Themis Bioscience GmbH will lay out plans for pre- and post-licensure studies to support approval MV-CHIK, one of the first chikungunya virus vaccines to approach pivotal clinical trials, as part of the US Food and Drug Administration's Vaccines and Related Biologic Products Advisory Committee topical meeting on 8 November.

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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 

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.

US FDA’s March Approval Candidates Take Aim At Established Markets

 

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.

GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 

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.

Rapidly Rising RMAT Designations Crack CBER’s Communication Freeze

 

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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US FDA’s March Approval Candidates Take Aim At Established Markets

 

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.

EU Decision Time For Topical Gene Therapy Beremagene Geperpavec And Five Others

 

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.

GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 

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.