Genmab closed out a busy third quarter for M&A in biopharma, picking up cancer biotech Merus for $8 billion. This deal—the year’s fifth largest—came just a week after Pfizer acquired rising obesity star Metsera for $4.9 billion. Just seven days later, Metsera made the New York–based pharma look like a genius with mid-stage data for one of the deal’s centerpiece therapies, MET-097i, showing 14% placebo-adjusted weight loss over 28 weeks.
After months of tarrying and threats, President Donald Trump announced last week that 100% tariffs would take effect Oct. 1—with broad exceptions for companies that have taken steps to build out their domestic manufacturing footprints. One company that has answered that call—as well as a letter sent by the president to 17 of the largest pharma companies requesting action on his most-favored-nation drug pricing policy—is Pfizer. In a joint oval office announcement with Pfizer CEO Albert Bourla and HHS officials, Trump said Pfizer would offer all new medicines at MFN prices.
Meanwhile, over at the FDA, CDER Director George Tidmarsh, who has flown relatively under the radar since taking the post in July, took to LinkedIn to address the subject of relying on surrogate endpoints in drug approvals. In a since deleted post, Tidmarsh called out Aurinia Pharmaceuticals’ lupus drug as an “egregious” example of this phenomenon. CDER’s sister agency, CBER, also made a splash last week, publishing three draft recommendations intended to accelerate the development of cell and gene therapies.
Speaking of CGT, maybe the biggest clinical development news of the year emerged from this space last week when uniQure announced that its gene therapy for Huntington’s disease, AMT-130, slowed disease progression by 75% after three years. With these data in hand, uniQure plans to file for FDA approval of the treatment in the first quarter of 2026. If successful, AMT-130 would be the first genetic therapy for the intractable neurodegenerative disease.
Finally, biopharma’s glass ceiling just got a little more tightly sealed. Emma Walmsley, the industry’s first female CEO, is stepping down after nine years at GSK, handing the reins to current chief commercial officer, Luke Miels. When Walmsley officially departs on Dec. 31, she will leave Vertex CEO Reshma Kewalramani and incoming Takeda CEO Julie Kim to represent the sisterhood at the highest ranks of the biopharma industry.
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