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  • STAT AI Prognosis newsletter tackles AI doomerism and offers guidance for health professionals
    The latest web edition of STAT’s AI Prognosis newsletter, authored by health tech reporter Brittany Trang, focuses on the growing chatter around AI doomerism. It aims to help readers cut through th…
    STAT · 1mo agoNeutral↗ source
  • Opinion: Mentally ill women need stronger support to become mothers
    Meg LeDuc writes in an opinion piece that maternal mental-health needs of women with serious psychiatric conditions have been largely ignored in the United States. She recounts her own history of…
    STAT · 1mo agoPositive↗ source
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Amgen reports positive Phase 3 results for Sjögren's drug; Novartis announces $900M radioligand partnership
Amgen said its CD40 ligand antagonist dazodalibep met the primary endpoint in a Phase 3 trial for Sjögren's syndrome, marking a notable achievement for the company. Novartis disclosed a $900 milli…
Endpoints · 1mo agoPositive readoutPositive↗ source
  • Amgen's Dazodalibep Shows Positive Results in First Phase 3 Trial for Sjögren’s Syndrome
    Amgen announced that its experimental drug dazodalibep, acquired through the Horizon Therapeutics acquisition, met the primary endpoint in the first of two Phase 3 trials for Sjögren’s syndrome, a…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Celldex shares drop as Phase 3 data for barzolvolimab show efficacy but raise anaphylaxis safety concerns
    Celldex reported Phase 3 results for barzolvolimab in chronic spontaneous urticaria, showing strong efficacy against hives and itching. Two cases of life-threatening anaphylaxis were observed amon…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Alkermes reports early proof-of-concept for orexin-2 drug in ADHD
    Alkermes announced early-stage trial results for ALKS 7290, an orexin‑2 receptor agonist originally being developed for narcolepsy, showing proof of concept in ADHD. The study reported dose‑depend…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Consumer groups call on FDA to strengthen generic drug testing and safety reporting under GDUFA IV
    Consumer health organizations used a public meeting on the reauthorization of the Generic Drug User Fee Amendments to press the FDA for more resources dedicated to testing generic medicines. The g…
    raps · 1mo agoRegulatoryNegative↗ source
  • HHS rolls out new FDA rule to allow non-animal testing methods in drug development
    The Department of Health and Human Services announced a new set of strategies aimed at shifting drug development away from animal testing toward human-based research methods. The FDA issued a fina…
    STAT · 1mo agoRegulatoryPositive↗ source
  • US officials launch probe into falling German drug prices amid EU pharma push for competitiveness
    US trade officials held a hearing on Tuesday about a possible investigation into the decline in Germany's payments for pharmaceuticals. Testimony presented arguments both supporting and opposing t…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Former FDA Commissioners Endorse Heidi Overton as Strong Choice to Lead Agency
    Two former FDA commissioners, Scott Gottlieb and Mark B. McClellan, wrote an opinion piece supporting Heidi Overton’s nomination to lead the agency. They note her confirmation hearing is set before…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Vertex reports early kidney drug data, boosting hopes for broad label ahead of next year's pivotal readout
    Vertex Pharmaceuticals disclosed early data from its experimental kidney disease therapy inaxaplin, showing improvements on a urine-based biomarker. The drug demonstrated positive changes in two s…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Viking Therapeutics reports obesity drug maintains weight loss after dosing switch, shares jump 36%
    Viking Therapeutics said its Phase 2 trial of the dual-acting obesity candidate VK2735 showed participants largely kept the weight they had lost when the dosing schedule changed from a weekly injec…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Celldex's barzolvolimab meets Phase 3 goals but safety concerns emerge
    Celldex announced that its experimental chronic hives treatment, barzolvolimab, achieved the primary endpoint in two Phase 3 trials. The trials demonstrated the drug's efficacy in reducing hive sy…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Nvidia-backed Iambic Therapeutics files for IPO, unveils AI-driven pipeline
    Iambic Therapeutics, a San Diego biotech that uses artificial intelligence to discover medicines, announced it has filed a registration statement to become a publicly traded company. The filing ma…
    Endpoints · 1mo agoDealNeutral↗ source
  • Novo Nordisk may secure more favorable terms under Medicare’s Bridge obesity drug program
    Novo Nordisk and Eli Lilly have been profiting from a Medicare pilot that caps obesity drug prices for seniors at $245 a month. Recent analysis suggests Novo could negotiate an even better arrangem…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Trump administration’s MFN drug pricing deals may cut projected Medicare savings by up to 80%
    The White House announced "most-favored-nation" pricing agreements with 26 pharmaceutical companies, saying the contracts would lower drug costs for federal programs. The deals require companies to…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Roche presents positive Phase 2 results for enicepatide in overweight and obese type 2 diabetes patients
    Roche has released new data from a Phase 2 trial of enicepatide, a peptide acquired from Carmot Therapeutics, focusing on overweight or obese adults with type 2 diabetes. The trial met its primary…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • GOP health policy guru continues to support $1 trillion Medicaid cuts, warning of next target
    Brian Blase, president of the Paragon Health Institute, has become a trusted adviser to Republican lawmakers and has publicly defended sweeping Medicaid reductions. The One Big Beautiful Bill Act,…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA issues third warning letter to Empower Pharmacy over GLP-1 weight-loss treatments
    The U.S. Food and Drug Administration sent a formal warning letter to Empower Pharmacy, a compounder based in Houston, concerning its GLP-1 weight-loss products. The notice marks the company's thi…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Trump Medicaid pricing plan may give Novo Nordisk unexpected financial boost
    STAT reports that the White House introduced a plan aimed at lowering the cost of drugs for Medicaid beneficiaries. The policy includes provisions that reduce prices of obesity treatments for senio…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Western pharma firms lobby Trump administration to preserve China partnership opportunities
    Western pharmaceutical companies are urging the Trump administration to permit continued collaborations with Chinese firms on promising drug candidates, despite a 2025 law that limits U.S. investme…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Federal AI Initiative Aims to Improve Chronic Heart Failure Care, Pending Doctor and Patient Acceptance
    A new federal program will test artificial‑intelligence tools in the management of chronic heart‑failure patients. The initiative is designed to explore how AI can support diagnosis, monitoring and…
    Endpoints · 1mo agoNeutral↗ source
  • Novo CEO acknowledges need to rebuild investor confidence after muted capital markets day
    Novo held a capital markets day on Monday in London, where the company outlined its strategy. Investors said the presentation left them underwhelmed. CEO Mike Doustdar acknowledged the reaction, s…
    Endpoints · 1mo agoNegative↗ source
  • Regulators Share Guidance for Effective Sponsor Meetings
    Regulators from the U.S. FDA, the U.K. MHRA and other European agencies met to outline best practices for sponsor‑regulator interactions. They highlighted that transparency, open collaboration, at…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Global regulators must align on new approach methodologies to give sponsors certainty
    New approach methodologies, or NAMs, are being promoted as ways to reduce reliance on animal testing in drug development. They promise faster, more humane studies while still providing safety data.…
    raps · 1mo agoRegulatoryNeutral↗ source