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Moment Of Truth For Belantamab Mafodotin, Trikafta And Turalio At EMA

 
• By Neena Brizmohun

A number of drug companies are set to learn the fate of their marketing authorization applications in the EU this week.

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The EMA is deciding whether to recommend approval for a number of drugs • Source: Shutterstock

GlaxoSmithKline could find out this week whether the European Medicines Agency will recommend that its multiple myeloma drug belantamab mafodotin be approved in the EU, setting the company on course to becoming the first to market a BCMA-targeting therapy for the disease.

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US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines

 
• By Bridget Silverman

US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease

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• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

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Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Chikungunya At US CDC: Bavarian Nordic’s Vimkunya Recommended, Valneva’s Ixchiq Adjusted

 
• By Bridget Silverman

Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.