1. Pink Sheet

US FDA Gets Wanted Pathogen Program, Manufacturers Get Longer BARDA Contracts In Competing Pandemic Prep Bills

 
• By Sarah Karlin-Smith

Key House and Senate committees advanced reauthorizations of the Pandemic All-Hazards Preparedness Act. It is unclear whether new perks for the FDA and drug makers will survive as the two chambers reconcile a myriad of differences between their plans. 

Earth surrounded by various pathogens
The Senate HELP Committee and the House Energy and Commerce Committee advanced pandemic prep bills 20 July and 19 July, respectively. • Source: Shutterstock

A Senate committee cleared a US Food and Drug Administration-requested pathogen preparedness program 20 July that is intended to help the agency avoid a repeat of the stress caused by the COVID-19 pandemic.

The

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US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
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Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
• By Neena Brizmohun

The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.