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FDA approves Johnson & Johnson's rare disease drug that's expected to compete...

The FDA approved a new rare disease drug that Johnson & Johnson hopes can compete with established medicines — and some that are yet to be approved — and become a megablockbuster. Regulators on...

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Immunic’s stock falls on multiple sclerosis data; Entrada’s layoffs

Plus, news about Henlius, Sandoz, Cellectar Biosciences, Ono Pharma and Altamira Therapeutics: Immunic’s Phase 2 multiple sclerosis readout: The company said vidofludimus calcium (IMU-838) reduced the...

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Endpoints Slack interview: Arc Institute's Patrick Hsu on AI bio, investing

Science is full of wunderkinds. But 31-year-old Patrick Hsu has already been on the frontiers of academic science, the biotech industry and now the world of nonprofit research. Hsu started doing lab...

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#AACR25: Scientists alarmed about future of cancer research

CHICAGO — Top cancer scientists, former NIH leaders, and patient advocates warned that the Trump administration's cuts to science funding will have an unprecedented impact on the future of cancer...

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Regeneron loses bid to fend off false claims fight over Eylea

Regeneron can’t dodge a lawsuit alleging it unlawfully inflated Medicare reimbursements for its eye drug Eylea and defrauded the US out of hundreds of millions of dollars. On Tuesday, a federal judge...

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More FDA staff leave, following broad firings at drug agency

The FDA office that approves new drugs is seeing more staff leave in early retirements, following broad cuts this month that targeted almost 20% of workers at the agency. The departures, many of which...

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BeiGene gets key win in patent spat over Brukinsa

A tribunal within the US Patent and Trademark Office invalidated several claims of a patent held by AbbVie’s Pharmacyclics, marking a key win for its rival BeiGene. The tribunal's ruling is a step...

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Teladoc buys virtual therapy startup UpLift for $30M

Teladoc has bought virtual therapy startup UpLift to sell mental health treatment, including treatment from its direct-to-consumer mental health business BetterHelp, to more patients. The telehealth...

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Moderna Q1 earnings: Company expands effort to control spending in ‘uncertain...

Moderna is expanding a cost control program as it seeks to break even in the coming years, despite challenges for vaccine makers from the Trump administration. On Thursday, the company said that its...

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Amicus grabs Dimerix’s rare kidney disease drug for $30M upfront

Amicus Therapeutics has paid $30 million cash upfront to license US rights to a late-stage therapy for a rare kidney disease from the Australian biotech Dimerix. The deal provides for milestone...

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Exclusive: AI biotech Stately Bio raises $12M for cell imaging

There are always trade-offs to make when studying cells. A biologist either kills the cell to scrutinize its insides or has to run more complex experiments, using tools like fluorescent tags to detect...

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Lilly meets sales expectations, but Novo gains on PBM win

The weight loss race between Eli Lilly and Novo Nordisk is heating up. On Thursday morning, Eli Lilly posted $12.73 billion in revenue in the first quarter, a 45% jump from ...

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Biogen Q1 earnings: Leqembi sales improving slowly following lackluster launch

Biogen said sales of its Eisai-partnered Alzheimer’s drug Leqembi crept close to the $100 million mark in the first three months of the year, after the product fared worse than expected during its US...

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After hunt for alternatives, Kronos Bio selects Tang Capital's Concentra for...

Kronos Bio, the drug developer long led by Gilead veteran Norbert Bischofberger, is calling it quits. The biotech said Thursday it's selling to Tang Capital's shell company Concentra Biosciences for 57...

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Arvinas ends plans for two Phase 3 breast cancer trials; Phathom makes cuts

Plus, news about Repare Therapeutics, DCx Biotherapeutics, Bloomsbury Genetic Therapies and Zucara Therapeutics: Arvinas drops planned late-stage trials: The protein degrader specialist, along with its...

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FDA approves Satsuma's migraine nasal spray after rejection in 2024

The FDA approved a new nasal spray for migraines that was developed by Satsuma Pharmaceuticals. Previously called STS101, the company said Wednesday that the drug's brand name is Atzumi and is ...

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US drugmakers seek clinical trials abroad as confidence in FDA wavers

When Siren Biotechnology CEO Nicole Paulk learned last month that top FDA official Peter Marks had resigned, she began looking outside the US for a place to host a planned clinical trial ...

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CROs raise the alarm as clients delay R&D plans over funding, tariff worries

Contract research organizations Icon and Medpace have both reported high rates of canceled or delayed R&D projects on the back of the Trump administration's funding cuts and potential...

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Future House debuts free AI agent for science platform

Open source doesn't necessarily mean easy access, and now the nonprofit Future House is trying to bridge that gap for AI tools in science by launching a new platform. On Thursday, Future House

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Zocdoc launches an AI voice assistant

Zocdoc, the health tech company known for helping patients book doctor visits online, is launching an AI assistant to schedule appointments — over the phone. The AI agent, Zo by Zocdoc ...

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