Pfizer, GSK Pentavalent Meningococcal Vaccine Recommendations Should Be Harmonized, ACIP Says

The US CDC committee appears on track to recommend GSK’s five-in-one vaccine when use of both a quadrivalent vaccine and a separate meningitis B vaccine are indicated at the same visit, the approach adopted for Pfizer’s Penbraya.

Train tracks
ACIP members favor aligning the recommendations for two pentavalent meningococcal vaccines. (Shutterstock)

Members of the US Advisory Committee on Immunization Practices favor harmonizing recommendations for use of Pfizer’s and GSK’s respective pentavalent meningococcal vaccines after the expected approval of the GSK product in February 2025.

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‘Highly Problematic’: Acting FDA Commissioner Paused Planned OK Of Novavax Shot

 

Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.

Updated: US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 

FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 

In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."

‘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.

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EU CHMP Opinions And MAA Updates

 

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.

‘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.

EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.