President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.

3 days ago · Unlike Vaxart, Novavax was not the recipient of a stop-work order. Instead, the Maryland-based company was waiting on an FDA decision regarding full FDA approval of its updated COVID-19 vaccine, Nuvaxovid, which finally came on May 16 —about six weeks after the original PDUFA date of April 1.. The overall approval progress was shrouded in uncertainty, with reports circulating that Novavax ...

3 days ago · A patient has died in Rocket Pharmaceuticals’ pivotal Phase II trial for its investigational gene therapy RP-A501, which the biotech is developing for Danon disease.. The patient in question developed complications related to capillary leak syndrome, characterized by fluid leaking out of blood vessels and into surrounding tissues, …

3 days ago · The Trump administration’s “Most Favored Nation” drug pricing policy is starting to take shape, with the president on Friday signaling that he wants Mehmet Oz, recently confirmed as administrator of the Centers for Medicare and Medicaid Services, to lead the negotiations.. Speaking at a Make America Healthy Again Commission event, President Donald Trump called Oz a “very tough hombre ...

May 8, 2025 · A Texas Judge on Wednesday took Eli Lilly ’s side in its ongoing court battle over compounded versions of its blockbuster GLP-1 drug tirzepatide, according to reporting from Reuters.. In a sealed order, Judge Mark Pittman upheld the FDA’s prior declaration that Lilly’s tirzepatide was no longer in shortage.

May 23, 2025 · The Trump administration’s attempts to radically shrink and reorganize the Department of Health and Human Services and other departments is on hold for now after a California judge issued a preliminary injunction.. The late Thursday order from U.S. District Judge Susan Illston, in the U.S. District Court for the Northern District of California, indefinitely stops HHS’ goal of reducing its ...

May 21, 2025 · Assets Under Management: $1.30 billion Dry Powder: Undisclosed The New York-based VC arm of Big Pharma Pfizer has been quiet this year, with just two investments. But a flurry of activity in the pandemic years topped up its portfolio to make it one of the largest funds by assets under management.

May 23, 2025 · The Trump administration’s Make America Healthy Again report blames chronic childhood diseases on poor diet, environmental chemicals, a lack of physical activity, stress and over medication. The 73-page report places some of the blame for the cumulative problem on pharma companies for aggressive lobbying and the “corporate capture of medical knowledge.”

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May 23, 2025 · The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously on Thursday for a monovalent COVID-19 shot that includes coverage of the virus’ JN.1 lineage, the same recommendation it made last year.. But looming over Thursday’s discussions—Leerink analysts in a note called it “the elephant in the room—was the FDA’s recently announced risk-based approval ...