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  • American Cancer Society recommends routine PSA screening for men 50-69, strengthens guidance for high-risk groups
    The American Cancer Society (ACS) has updated its prostate-cancer screening guidelines, now advising men at average risk aged 50 to 69 to have a PSA blood test every two years. This replaces the 20…
    STAT · 7h agoRegulatoryPositive↗ source
  • 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 · 7h agoNegative↗ source
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  • 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 · 3h 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 · 7h agoPositive readoutNeutral↗ 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 · 2h agoRegulatoryNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 3h agoLayoffsNegative↗ 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 · 2h ago↗ source
  • Novartis' Zolgensma linked to tumors as FDA probes gene therapy and orders GLP-1 eye risk warnings
    Novartis confirmed that nine patients who received its Zolgensma gene therapy for spinal muscular atrophy have developed tumors, prompting the FDA to open an investigation into the approved treatme…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • U.S. faces possible loss of measles elimination status as WHO panel convenes
    A WHO regional committee will meet for four days to decide if the United States still meets criteria for measles elimination. Current indicators suggest the country may no longer qualify, raising…
    STAT · 1d agoRegulatoryNegative↗ source
  • Capricor trims 10% of workforce as FDA decision on Duchenne cell therapy approaches
    Capricor Therapeutics announced it is cutting about 10% of its staff ahead of an upcoming FDA decision on its Duchenne muscular dystrophy cell therapy, deramiocel. The biotech said it had 231 full…
    BioSpace · 1d agoLayoffsNegative↗ source
  • Former ER doctor argues that limiting data input can improve clinical AI tools
    Graham Walker, a former emergency‑room physician and co‑founder of MDCalc, was interviewed for STAT’s AI Prognosis newsletter about his new AI tool. Walker explains that giving AI systems only the…
    STAT · 1d agoNeutral↗ source
  • Health-care providers sue employers over out-of-network medical bills
    Providers are increasingly filing lawsuits against employers, arguing that the companies are liable for out-of-network medical charges that insurers have not fully paid or have delayed. One recent…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Bayer's Sunharbo becomes first FDA-approved factor XIa inhibitor blood thinner
    Bayer's oral anticoagulant Sunharbo, known as asundexian, has received FDA approval, making it the first factor XIa inhibitor cleared for use in the United States. The drug is intended to lower th…
    BioSpace · 2d agoApprovalPositive↗ source
  • Ionis shares tumble over $1 billion as Tryngolza sales forecast cut in half
    Ionis Pharmaceuticals saw its market value drop by more than $1 billion after it lowered its sales outlook for Tryngolza, a triglyceride‑lowering therapy. The company now expects $50 million in sa…
    STAT · 2d agoNegative↗ source
  • FDA approves Bayer's Sunharbo, a new class drug to lower stroke recurrence
    The FDA has given its nod to a Bayer medication designed to cut the risk of another stroke in patients who have already suffered one. The product, marketed as Sunharbo, belongs to a newly created…
    STAT · 2d agoApprovalPositive↗ source
  • Pharma access plans rise to 69% of late-stage drugs but gaps remain for non-communicable diseases
    A new analysis shows that many large drug makers are expanding programs to make medicines available in low- and middle‑income markets, but progress is uneven across disease areas. Access plans now…
    STAT · 2d agoNeutral↗ source
  • Former Eli Lilly sales rep sues, alleging termination after raising concerns over off-label promotion of Mounjaro for weight loss
    A former senior territory manager at Eli Lilly has filed a federal lawsuit claiming she was dismissed after reporting that the company was marketing its diabetes drug Mounjaro as a weight‑loss solu…
    STAT · 2d agoRegulatoryNegative↗ source
  • Dutch regulators probe Biogen over exclusive MS test for Tysabri patients
    Dutch competition authority (ACM) has opened an investigation into Biogen concerning its handling of a blood test linked to its multiple sclerosis drug Tysabri. The probe focuses on whether Biogen…
    STAT · 2d agoRegulatoryNegative↗ source
  • PepGen reports promising early results for myotonic dystrophy type 1 drug in six-patient trial
    PepGen announced that its experimental therapy for myotonic dystrophy type 1 showed the most encouraging early data yet in a small study. The trial involved six patients who received the drug for 1…
    STAT · 2d agoPositive readoutPositive↗ source
  • Flu season this year appears to be affecting teens and young adults more severely, experts say
    The article notes that flu activity this year has already resulted in at least 1.7 million reported cases, and health experts are observing that teenagers and young adults are experiencing higher r…
    STAT · 2d agoNeutral↗ source
  • PepGen soars on promising early data for muscular dystrophy drug
    While from a small study, the findings suggest PepGen’s therapy compares favorably to other RNA-based medicines in testing at Novartis and Dyne Therapeutics.
    BioPharma Dive · 1d ago↗ source
  • STAT+: GLP-1s are given an FDA warning for rare eye condition risk
    The FDA warned that GLP-1 drugs carry a potential risk of a rare but serious eye condition sometimes referred to as an “eye stroke.”
    STAT · 2d ago↗ source
  • FDA approves Bayer’s Sunharbo, first Factor XIa inhibitor to lower stroke recurrence risk
    The Food and Drug Administration has approved Bayer's new medication intended to prevent another stroke in patients who have already experienced one. The drug, sold under the brand name Sunharbo,…
    STAT · 2d agoApprovalPositive↗ source
  • Lilly's oral GLP-1 Foundayo cuts sleep apnea severity in Phase 3, paving way for second FDA filing
    Lilly said it will submit its oral GLP-1 drug Foundayo for FDA approval in obstructive sleep apnea after a late‑stage trial showed strong efficacy. The Phase 3 ATTAIN-OSA study enrolled about 712…
    BioSpace · 3d agoPositive readoutPositive↗ source
  • Argenx to acquire peptide specialist Unnatural Products in deal worth up to $1.15 billion
    Argenx announced it will purchase Unnatural Products, a peptide discovery biotech, in a transaction that could total up to $1.15 billion. The deal provides $550 million upfront, with additional co…
    BioSpace · 3d agoDealPositive↗ source