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3,309 stories matching this filter · ← front page

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  • Alnylam faces slowdown in Amvuttra sales, putting its growth ambitions at risk
    Alnylam’s market narrative has long hinged on the performance of its cardiomyopathy drug Amvuttra. The company once hoped the therapy could lift its valuation toward the $100 billion range. Recent…
    STAT · 1d agoNegative↗ source
  • New governors should prioritize health hires, vaccination data, and a focused agenda
    Mandy Cohen and Ellen Montz, former state health leaders, write an opinion piece aimed at the 21 governors who will assume office on Jan. 1. They draw on their experience at the CDC, state health d…
    STAT · 1d agoPositive↗ source
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BMS consolidates R&D under chief medical officer Cristian Massacesi as chief research officer Robert Plenge exits
Bristol Myers Squibb announced that starting Jan. 1, its chief medical officer and head of development, Cristian Massacesi, will lead a newly combined research and development unit, merging previou…
Fierce Biotech · 1d agoNeutral↗ source
  • Neurosterix secures $105M Series B to launch phase 2 schizophrenia trial
    Addex Therapeutics' spinout Neurosterix announced a $105 million Series B financing to fund its upcoming phase 2 trial of NTX-253 for schizophrenia. The round was led by a syndicate of leading lif…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA pauses voucher program as Eli Lilly's GLP-1 weight-loss drug cleared in China; experts see AI aid for device regulation
    The U.S. Food and Drug Administration announced it is shelving the commissioner's voucher program, effectively pausing the incentive that speeds up review of certain products. Eli Lilly secured ap…
    raps · 1d agoRegulatoryNeutral↗ source
  • EMA seeks industry input on draft guideline for biomarker-guided therapy approvals
    The European Medicines Agency has published a draft guideline that details the information required for approving medicines that use biomarkers to select patients. The agency is opening a public c…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA asks industry for feedback on improving patient-level real-world data submissions
    The FDA announced a request for comments on ways to address challenges associated with submitting patient-level real-world data and evidence in drug and biologic applications. The agency is seekin…
    raps · 1d agoRegulatoryNeutral↗ source
  • Bristol Myers appoints Cristian Massacesi as head of R&D as Robert Plenge exits
    Bristol Myers Squibb announced a reorganization of its research and development organization, merging the research and development units under a single leader. Cristian Massacesi, currently chief…
    BioPharma Dive · 23h agoNeutral↗ source
  • Biogen prepares to unveil results of litifilimab Phase 3 TOPAZ-1 and TOPAZ-2 lupus trials in December
    Biogen is set to release the readout from two pivotal Phase 3 studies, TOPAZ-1 and TOPAZ-2, evaluating its lupus drug litifilimab. The data are expected in the first half of December and will be th…
    STAT · 1d agoPositive readoutNeutral↗ source
  • FDA suspends National Priority Voucher pilot and pauses release of complete response letters
    The Food and Drug Administration has quietly ended the National Priority Voucher pilot, a program that was designed to speed the review of certain drug candidates. In addition, the agency appears…
    Fierce Biotech · 1d agoRegulatoryNeutral↗ source
  • Vor Bio pays RemeGen $10 million for rights to long-acting autoimmune drug candidate RC298
    Vor Bio announced a licensing agreement with RemeGen, paying $10 million upfront in cash and issuing warrants valued at about $46 million for rights to RC298 outside Greater China. RC298 is a long…
    Fierce Biotech · 1d agoDealPositive↗ source
  • STAT+: Blackstone backs Pfizer’s bet on monthly obesity treatment
    Pfizer spent up to $10 billion to buy Metsera last year. Now, it’s bringing in private equity behemoth Blackstone to help pay for the deal.
    STAT · 22h agoRegulatoryNeutral↗ source
  • Newly elected doctors and scientists aim to rebuild public trust in science after midterm wins
    Last week doctors and scientists across the United States were elected to office, with the help of the group 314 Action. The organization, which supports Democratic candidates with scientific backg…
    STAT · 1d agoNeutral↗ source
  • Kyverna pauses development of next-gen autoimmune CAR-T KYV-102 to focus on neurologic miv-cel program
    Kyverna Therapeutics announced it is halting work on its next-generation CD19 CAR-T candidate KYV-102, which had been positioned as a follow-up to its lead autoimmune CAR-T miv-cel. KYV-102 was de…
    Fierce Biotech · 1d agoNegative↗ source
  • Specialized AI tools could streamline medical device regulatory work, experts say, but need expert oversight
    At a recent RAPS AI in Regulatory conference in Barcelona, a panel of experts discussed the role of specialized artificial intelligence in meeting regulatory requirements for medical devices. They…
    raps · 1d agoRegulatoryNeutral↗ source
  • ARPA-H bets $4.9 million on ibogaine for PTSD treatment in veterans
    The U.S. department of health and human services announced a $4.9 million bet to advance the development of ibogaine for post-traumatic stress disorder (PTSD).
    Fierce Biotech · 1d agoNeutral↗ source
  • Study finds Black Americans share many concerns with MAHA despite low overall support
    Jerel Ezell, an epidemiologist at the University of Chicago Medical Center, writes an opinion piece examining the complex relationship between the MAHA movement and Black Americans. A 2025 poll by…
    STAT · 1d agoNeutral↗ source
  • Pfizer taps Blackstone for up to $1.5B to pave path to GLP-1's obesity launch
    Pfizer has secured up to $1.5 billion from Blackstone Life Sciences to fund development of its monthly GLP-1 receptor agonist.
    Fierce Biotech · 1d agoNeutral↗ source
  • Blackstone bets $1.5B on Pfizer’s obesity drug
    The deal will support a sprawling Phase 3 program for a monthly GLP-1 shot Pfizer acquired by winning a bidding war for the drug’s previous owner, Metsera.
    BioPharma Dive · 22h ago↗ source
  • Experts update prostate cancer screening guidelines for men
    Are you an American man between 50 and 69? You might want to get checked for prostate cancer, ACS says in reversal of previous guidelines.
    STAT · 1d ago↗ source
  • Abbott nabs FDA approval, CE Mark for implantable cardioverter-defibrillator lead
    Abbott has received both FDA and CE Mark approval for its UltiSynq defibrillation lead tech, which is designed to deliver both conduction system pacing and defibrillation therapy.
    Fierce Biotech · 2d agoApprovalPositive↗ source
  • Study of 100,000 diverse Americans uncovers thousands of new drug-response genetic variants
    A new analysis of data from the NIH All of Us program examined nearly 100,000 participants from a wide range of ancestries. Researchers identified thousands of previously unknown genetic variants i…
    STAT · 1d agoPositive↗ source
  • U.S. 'most-favored nations' policy prompts drugmakers to reconsider overseas launches
    The White House's "most-favored nations" rule, which would tie foreign drug prices to U.S. prices, is causing U.S. pharma firms to rethink launching products abroad. Companies are exploring strate…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Senate Health Committee Schedules Vote on FDA Commissioner Nominee Heidi Overton
    Senate health committee set a vote for November 18 on President Trump's nominee Heidi Overton to become FDA commissioner. The outcome will determine whether the nomination proceeds to the full Sen…
    STAT · 2d agoRegulatoryNeutral↗ source
  • BioNTech spends $205 million on FDA priority review voucher to accelerate oncology pipeline
    BioNTech has agreed to pay $205 million to acquire an FDA priority review voucher, a tool that can shorten the agency's standard review period from ten months to six months. The voucher was previo…
    Fierce Biotech · 2d agoDealPositive↗ source