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  • FDA Commissioner Marty Makary Ousted After Trump-Backed Action
    The piece reports that Marty Makary, who had been serving as FDA commissioner, is no longer in the role. His removal came after headlines emerged that President Donald Trump had signed a measure…
    Endpoints · 6mo agoRegulatoryNegative↗ source
  • Lakefront Biotherapeutics rebrands from Galapagos as it seeks turnaround from Chicago office
    Lakefront Biotherapeutics, formerly known as Galapagos, announced a rebranding effort aimed at reviving the company’s fortunes. The change reflects a strategic shift as the firm looks to reposition…
    Endpoints · 6mo agoNeutral↗ source
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  • Isomorphic Labs secures $2.1 billion Series B, cementing AI drug-discovery leadership
    Isomorphic Labs announced on Tuesday that it has closed a $2.1 billion Series B financing round. The sizable round underscores the company’s position as a bellwether for using artificial intellige…
    Endpoints · 6mo agoDealPositive↗ source
  • Bristol Myers Squibb partners with Hengrui Pharma in $15.2 billion, 13-asset deal
    Bristol Myers Squibb announced a partnership with China’s Hengrui Pharma that includes 13 assets. The transaction is reported to be valued at up to $15.2 billion, highlighting the scale of collabo…
    Endpoints · 6mo agoDealNeutral↗ source
  • Serif Biomedicines claims breakthrough in non-viral gene therapy demonstrated in monkeys
    Serif Biomedicines, a startup launched by Flagship Pioneering last month, announced it believes it has overcome two key technical hurdles that have limited non-viral gene therapy. The company says…
    Endpoints · 6mo agoPositive↗ source
  • Alkermes reports Phase 3 success for Lumryz; Boehringer announces antibody partnership
    Alkermes announced that its narcolepsy medication Lumryz, which received regulatory approval in 2023, achieved its primary efficacy endpoint in a Phase 3 trial. The study met the predefined criter…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Eli Lilly suggests low-dose Zepbound and Foundayo could safely maintain weight loss at lower cost
    New trial data indicate that lowering the dose of Eli Lilly's obesity injection Zepbound may still provide effective weight‑loss maintenance while improving safety. The study also highlights Found…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • EU Parliament and Council provisionally approve Critical Medicines Act to strengthen drug supply chains
    The European Parliament and the Council have provisionally voted to adopt the Critical Medicines Act, marking a key step toward its implementation. The legislation is designed to reinforce the EU’…
    Endpoints · 6mo agoRegulatoryPositive↗ source
  • Iran war disruptions ripple through pharma supply chain, raising raw material and shipping costs
    The ongoing conflict between Iran and its adversaries has entered its third month, and analysts are now seeing early signs that the fighting is affecting the pharmaceutical supply chain. Disruptio…
    Endpoints · 6mo agoNegative↗ source
  • Pfizer, Arvinas sell recently approved breast cancer drug to Rigel for $35 million
    Pfizer and its partner Arvinas have agreed to transfer the commercial rights of a breast cancer therapy to Rigel Pharmaceuticals. The drug had just received regulatory approval, marking a mileston…
    Endpoints · 6mo agoDealNegative↗ source
  • Bayer signals cautious yet aggressive push into pharma acquisitions after five-year pause
    Bayer's CEO Bill Anderson told investors on the first-quarter earnings call that the company is ready to re-enter the pharmaceutical merger-and-acquisition market after a five-year hiatus. He emph…
    Endpoints · 6mo agoDealPositive↗ source
  • Knit Health secures $11.6M seed round to develop doctor-like AI for healthcare operations
    Knit Health, a startup spun out of UC Berkeley, announced it has closed a seed financing round of $11.6 million. The round was co‑led by Uncork Capital, providing the capital the company plans to…
    Endpoints · 6mo agoDealPositive↗ source
  • FDA Commissioner Marty Makary steps down after weeks of uncertainty
    Marty Makary, the commissioner of the U.S. Food and Drug Administration, announced his resignation on Tuesday. The decision came after his employment status was uncertain for several days, accordi…
    Endpoints · 6mo agoRegulatoryNeutral↗ source
  • FDA reopens comment period for BHT and launches post-market chemical safety program
    The U.S. Food and Drug Administration announced two actions as part of its ongoing food chemical safety agenda. The agency will reopen the comment period for the Request for Information on butylat…
    fda press · 6mo agoRegulatoryNeutral↗ source
  • Journalist reflects on challenges of reporting healthcare AI after fellowship
    The author participated in a journalism fellowship that focused on health technology reporting. The experience underscored the importance of continuously examining the incentives that drive AI pro…
    Endpoints · 6mo agoNeutral↗ source
  • CSL shares plunge to nine-year low after cutting revenue forecast and announcing $5 billion impairment
    CSL's shares fell to their lowest level since early 2017 after the company reduced its full‑year revenue guidance by roughly four percent. The guidance cut signals slower sales growth than previous…
    Endpoints · 6mo agoEarningsNegative↗ source
  • Rezdiffra Beats Wall Street Forecasts as MASH Market Expands
    Rezdiffra, a drug candidate targeting metabolic dysfunction‑associated steatohepatitis (MASH), is outperforming analysts' expectations according to recent commentary. The optimism comes as the mar…
    Endpoints · 6mo agoPositive↗ source
  • Daiichi Sankyo targets $15 billion in oncology sales by 2030 as it expands ADC franchise
    Daiichi Sankyo released a new five‑year business plan that sets a goal of nearly $15 billion in oncology revenue by 2030. The target is part of a broader ambition to push total company sales past 3…
    Endpoints · 6mo agoNeutral↗ source
  • Inhibrx reports combo of Keytruda and INBRX-106 reduces tumors more than Keytruda alone in metastatic head cancer
    San Diego biotech Inhibrx says its experimental drug INBRX-106, when added to Merck's immunotherapy Keytruda, led to a higher rate of tumor shrinkage than Keytruda by itself. The observation comes…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Braveheart Bio's Hengrui-licensed cardiac therapy shows positive mid-stage trial results
    Braveheart Bio announced that its heart muscle therapy, licensed from Jiangsu Hengrui Pharmaceuticals, has achieved a positive outcome in a Phase 2 trial. The mid-stage study met its primary endpo…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • European regulators approve Fractyl Health's first GLP-1 gene therapy clinical trial
    European regulators have given the green light for Fractyl Health, a biotech near Boston, to begin its first human study of a GLP-1 gene therapy. The therapy aims to provide a one-time treatment t…
    Endpoints · 6mo agoRegulatoryPositive↗ source
  • Optum Rx Announces Transparent Pharmacy Model Set to Launch in 2027
    Optum Rx, a unit of UnitedHealth Group, introduced a new pharmacy benefit model that promises clear fee structures for its customers. The model is designed to give members visibility into the full…
    Endpoints · 6mo agoPositive↗ source
  • Novo Nordisk secures biotech partner for Parkinson's cell therapy as GSK signs hepatitis B drug deal in China
    Novo Nordisk has found a biotech partner to advance its early‑stage Parkinson's disease cell therapy, giving the program a new development home. GSK disclosed a commercial agreement to sell its he…
    Endpoints · 6mo agoDealNeutral↗ source
  • Endpoints Weekly highlights biotech company models, a quirky startup story, and earnings season updates
    The latest edition of Endpoints Weekly introduces a look at emerging biotech company structures, noting how new models are reshaping the industry. It also features a light‑hearted piece about a st…
    Endpoints · 6mo agoNeutral↗ source
  • Trump reportedly plans to dismiss FDA Commissioner Marty Makary
    Multiple media outlets report that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The reports say the decision has not been finalized and could still be…
    Endpoints · 6mo agoRegulatoryNegative↗ source