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PI3K Inhibitors: Overall Survival, Adverse Events And Dose Optimization Top US FDA’s Concerns

 
• By Sue Sutter

Agency will ask its Oncologic Drugs Advisory Committee whether future approvals in the class should be supported by randomized data, instead of single-arm studies, given potential overall survival detriment seen in randomized trials to date for four drugs.

Repeating pattern
There is a concerning, repeating pattern in overall survival results from PI3K randomized, controlled trials, the FDA says. • Source: Alamy

The US Food and Drug Administration is asking its Oncologic Drugs Advisory Committee to take into consideration three factors in deciding whether future approvals in the phosphatidylinositol 3-kinase (PI3K) inhibitor class should be based upon randomized data.

There exists a narrow range between effective and toxic doses in this class and, to date, the sponsors of approved...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.