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The polycythemia vera field is heating up, with Disc Medicine and Silence Therapeutics each advancing next-generation therapies, playing catch-up to Takeda and Protagonist Therapeutics, who won the FDA’s approval last month for Mimrylo.
Frazier’s life science fund has already benefited several successful biotechs, including Verona Pharma, which was acquired by Merck for $10 billion, and Carmot Therapeutics, which Roche bought for $2.7 billion.
Novartis’ shares fell 13% this week after the report of three separate late-stage asset failures. The impact went beyond the Swiss drugmaker, dragging peers down across the market.
Newly solidified in their roles as the heads of CBER and CDER, Karim Mikahil and Michael Davis have been working for months to right the ship that had begun to capsize under former Commissioner Marty Makary. Meanwhile, Jared Seehafer will become the first-ever deputy commissioner focused on artificial intelligence.
Back-to-back failures of multiple late-phase trials have raised questions about how Novartis has deployed capital in pursuit of drugs to drive growth through the 2030s.
A few months after a new CEO stepped up to helm Takeda, the drugmaker will now have to prepare for another leadership change as its long-time R&D head plans his exit.
The enrollment pause comes after BHV-7000 failed to show efficacy in a midstage depression trial late last year. The news is another regulatory hit for Biohaven after the FDA declined to approve its spinocerebellar ataxia treatment in November 2025.
With multiple drug pricing initiatives like Most Favored Nation now in force, drugmakers have to reinvent their commercial strategies to stay ahead of the fast-moving policy environment, according to a new report from Numerof & Associates.
Encoded Therapeutics’ lead asset ETX101 is a gene therapy being tested for Dravet syndrome. Phase 1/2 data showed substantial reductions in seizures.
Despite falling short of analyst expectations, Tyra Biosciences is taking its cancer drug to registrational development for non-muscle invasive bladder cancer.