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Center for Drug Evaluation and Research HeadGeorge Tidmarshwill oversee the Center for Biologics Evaluation and Research on an acting basis after Vinay Prasad’s abrupt departure hours after the recording of last week’s episode ofThe Weekly. While the situation is being billed as temporary, rumors are swirling that structural changes may be afoot at the FDA with Commissioner Marty Makary looking forbetter drug, biologic alignment.
Meanwhile, the agency has come under criticism for another recent decision—oneapparently drivenby CDER’s Oncology Center of Excellence director Richard Pazdur: the rejection of Replimmune’s advanced melanoma drug, RP1. According to reporting by multiple outlets, Pazdur opposed the consensus opinion of CBER staff to approve the drug. The research team behind Replimmune’s Phase III study penned an open letter to the FDA on Friday responding to the issues outlined in the agency’s complete response letter. Meanwhile, the FDA’s Sarepta saga continues, highlighting“unprecedented” FDA leaksand a veritable communications disaster.
On the business side of biopharma, Q2 earnings continue to unfurl, with Pfizer,Vertex,BioNTech,MerckandModernaall reporting this past week. Merck’s $3 billion savings push is projected to claim 6,000 jobs, contributing to abrutal Julythat saw the entire biopharma industry axe 7,900 employees, a 487% year-over-year increase, based onBioSpacetallies. Meanwhile,PfizerCEO Albert Bourla confirmed he has been in direct contact with President Donald Trump to negotiate a path forward on Most Favored Nation drug pricing after the presidentsent lettersto 17 Big Pharma companies—and posted on his Truth Social platform—asking them to comply with the policy within 60 days or face potential unspecified consequences.
In other policy news, the Centers for Medicare and Medicaid Services is reportedly consideringcoverage of GLP-1 drugsfor weight management and obesity—reviving a Biden-era proposal the Trump admin scrapped earlier this year.
Finally, inBioPharm Executivethis week, we have a special report on the situation in China as international drugmakers swoop into the region to find new drug candidates, while other companies build their therapeutic farm systems from incubators and venture arms. And check outBioSpace’s brand newManufacturing Brief, where we bring you the latest news and analysis in the area of biopharma manufacturing, starting with afeatureon how to make cell and gene therapies commercially viable.
Editor’s note (Aug. 7): This story was updated to clarify that Merck’s cuts are projected cuts that are part of a multiyear process.