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Makary hearing updates: Trump FDA nominee faces Senate

Johns Hopkins surgeon Marty Makary, President Donald Trump's pick to lead the FDA, emerged from his Senate confirmation hearing relatively unscathed. During the less than two-hour hearing, Makary vowed...

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Denali stops some work on ALS drug after analysis showed no impact on key...

Denali Therapeutics’ ALS program showed no effect on an important neurodegeneration biomarker that could have been used for FDA approval after a failed topline readout earlier this year. The company is...

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Merck KGaA says earlier moves to localize manufacturing help ease Trump...

Merck KGaA flagged that it might get hit by President Donald Trump’s tariffs against China, but CEO Belén Garijo said this is likely to be “manageable” due to its earlier execution of regionalizing its...

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Corrected: Merck KGaA’s mixed Phase 2 lupus results; Zymeworks pauses work on...

Plus, news about Tris Pharma and ARS Pharmaceuticals: Merck KGaA’s lupus drug yields mixed data in mid-stage trial: The drugmaker’s TLR7/8 inhibitor, called enpatoran, missed one of two Phase 2 primary...

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Luxa's stem cell therapy for dry AMD shows early promise

Luxa Biotechnology said Thursday that its stem cell therapy helped improve vision in a handful of people with a common form of an age-related eye condition. In its lowest dose cohort, the Phase 1/2a...

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Novo Nordisk’s rare disease ‘company within a company’ has an open goal in...

Novo Nordisk is known for making therapies for some of the world’s most prevalent conditions, but it's also working on candidates for some of the least common. Though the company’s rare disease unit is...

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Longtime biotech investor Frazier Life Sciences is raising its latest venture...

Frazier Life Sciences, a decades-old biotech investor, is raising another heap of dry powder to create and invest in startups, according to publicly available documents from one of its investors. The...

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CordenPharma’s €100M investment top-up; Cytiva to lay off 85 staffers

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. CordenPharma is investing another €100 million ($108 million) into...

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Healthcare is bullish on AI

It’s only been about two years since healthcare really started adopting generative AI. Now, it’s no longer just demos testing out transcription tools. Timed to the HIMSS conference, Microsoft, Google ...

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Moderna stands by its Covid vaccine patents after PTAB decision

Moderna says its long-running patent dispute with Pfizer and BioNTech isn't over, even after a decision by an administrative tribunal that invalidated two of its Covid-19 vaccine-related patents. The...

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Walgreens to go private in $10B deal

Walgreens is entering a new chapter as it agrees to sell itself to a private equity firm, ending its rocky run as a publicly-traded company. New York-based Sycamore Partners is acquiring the retail...

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J&J axes Phase 3 depression program due to ‘insufficient efficacy’ shortly...

Johnson & Johnson scrapped its Phase 3 program for aticaprant, an experimental and new type of major depressive disorder drug, following "insufficient efficacy," the pharma giant disclosed late...

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Tune’s CEO search ends as John McHutchison takes top spot; More from Pfizer’s...

John McHutchison started Monday as CEO and chairman of Tune Therapeutics, after sitting on the company’s board for two years. One message he wants to make clear: “We’re not a gene ...

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Roche launches new research center with Harvard in Boston area

Roche announced a new research hub on Friday in partnership with Harvard that it hopes will accelerate efforts in disease biology, engineering and AI. The hub will be called the Roche Genentech...

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CytomX, Amgen pass on T cell engager; Molecular Partners ends work with Novartis

Plus, news about Atea Pharmaceuticals: CytomX, Amgen stop work on T cell engager: The partners decided to end development of an EGFR-targeting T cell engager based on “clinical observations to date ...

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Jeb Keiper steps down from Nimbus CEO post, business chief to take over

Nimbus Therapeutics is getting a new CEO after more than six years, as Jeb Keiper passes the baton to Abbas Kazimi. Keiper spent over a decade at Nimbus, starting as its chief business officer in ...

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At $300M Kardigan startup, former MyoKardia team unveils its first drug, and...

When some former MyoKardia execs reunited with $300 million for a new "heart health" biotech earlier this year, they were tight-lipped about their in-licensed clinical-stage assets. The company ...

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What FDA, NIH hearings say about Trump drug, health policy

President Donald Trump's nominees for NIH director and FDA commissioner sailed through their respective confirmation hearings this week, facing few difficult questions and offering few controversial...

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How bluebird's buyout offer went from $100M upfront to $29M

Bluebird bio went from a high-flying $10 billion company in 2018 during the heyday of gene therapy to being sold for a measly $29 million upfront in a fire sale last month. But it almost ...

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Bayer eyes capital raise as it grapples with Monsanto cases

Bayer is asking shareholders to authorize a potential equity offer that would allow it to quickly raise billions of euros to deal with ongoing Monsanto litigation. The company requested an equity...

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