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Makary resigns |
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Makary left the agency on Tuesday, following a flurry of reports that indicated the president had signed off on firing him. Trump, however, said later that he knew
“nothing about it.” The former commissioner had been under pressure on a range of issues, from flavored vapes to drug approval decisions. One major criticism against Makary had come from rare-disease advocates who argued that he had stifled approvals and shifted regulatory standards.
It remains unclear who Makary’s permanent successor will be. Trump said Kyle Diamantas, the FDA’s top food official, would serve as acting commissioner. Endpoints Executive Editor Drew Armstrong wrote that many of the challenges Makary was up against will still be there for the next commissioner. You can read the full Post-Hoc piece here. |
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Biogen reports Alzheimer’s data |
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Biogen reported heavily anticipated Alzheimer’s data this week, saying its tau-targeting drug BIIB080 missed its primary endpoint in a Phase 2 study. But it also claimed to see signs of efficacy showing it slowed patients’ clinical decline at all doses after 18 months. The company will move the program into Phase 3 testing despite missing the primary endpoint.
Alzheimer’s drug development has a long string of high-profile failures, with Biogen often being involved. Back in 2021, the biotech got its anti-amyloid drug Aduhelm approved despite two Phase 3 failures and a near-unanimous negative adcomm vote. The drug was a commercial disaster as insurers declined to cover it, and Biogen emerged from the debacle as a leaner company with a new CEO in Chris Viehbacher.
Executives are hopeful that with the changes, Biogen can avoid repeating its past mistakes. “We don’t want to be too impulsive about moving to Phase 3,” Biogen Head of Development Priya Singhal told Endpoints News. Read more about the data and Biogen’s plans here. |
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BMS signs megadeal with Hengrui |
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Jiangsu Hengrui Pharmaceuticals, also known as just Hengrui, is China’s largest pharma company, boasting one of the biggest pipelines in the industry. This week, it lined up Bristol Myers Squibb as its latest partner in a deal worth up to $15.2 billion. The total value of the Tuesday pact marks one of the largest East-to-West cross-border deals in industry history.
Most of that cash is tied up in milestones, as BMS will pay just $600 million upfront. But the deal is very expansive, involving 13 programs. Four are oncology and hematology assets from Hengrui; four are immunology programs from Bristol Myers; and the remaining five will be jointly discovered and developed by the pair.
The total deal value rivals the up to $12 billion tie-up that Hengrui forged with GSK in 2025. But that doesn’t reach the roughly $18.5 billion outlay that AstraZeneca inked with CSPC Pharmaceutical for obesity and other metabolic drugs this past January. Read more from Endpoints’ biotech correspondent and deal whiz Kyle LaHucik here. |
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Takeda to make more cuts |
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The Japanese pharma will cut roughly 9% of its workforce over the next fiscal year, or about 4,500 roles. That figure doesn’t account for hiring plans, including 2,200 roles that are currently open and new jobs that will be created throughout the year, a Takeda spokesperson told Endpoints. The announcement came in Takeda’s fourth-quarter earnings report on Wednesday, as incoming CEO Julie Kim prepares to take the reins in
June.
Outgoing CEO Christophe Weber laid out plans for a multiyear restructuring in 2024. Since then, the company has closed a research center in San Diego, trimmed its pipeline and made hundreds of staff cuts. Kim said she
would make efficiency a priority going forward, as Takeda looks to focus resources around its late-stage pipeline. She cited three upcoming launches that have the potential to be blockbusters.
Takeda isn’t the only biopharma company making four-digit layoffs. Novo Nordisk announced in September 2025 that it would cull 9,000 jobs, and Merck said in July that it was targeting 6,000 positions. Bayer CEO Bill Anderson confirmed this month that it’s made 14,000 reductions as part of a broader restructuring. |
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Five burning questions for Isomorphic |
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Isomorphic Labs said Tuesday it had closed a $2.1 billion Series B round, cementing its bellwether role in using AI for drug discovery. But senior biopharma correspondent Andrew Dunn, who is Endpoints’ point man on artificial intelligence’s role in biopharma, has five burning questions for the company.
Most importantly, Dunn asks: Where is the pipeline? Despite raising over $2.7 billion in total and operating for about five years, Isomorphic has not provided meaningful detail on its drug programs. The company expects to enter the clinic by the end of 2026, but execs won’t get any more specific than that. Read more from Andrew here. |
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