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  • Sanofi’s tolebrutinib receives EU CHMP endorsement for specific multiple sclerosis patients despite US FDA setback
    Sanofi's BTK inhibitor tolebrutinib is moving toward approval in the European Union for a subset of multiple sclerosis patients. The Committee for Medicinal Products for Human Use (CHMP) of the Eu…
    Endpoints · 6mo agoRegulatoryPositive↗ source
  • FDA to fast-track review of three psychedelic therapies for depression and PTSD
    The FDA announced it will accelerate the review of psychedelic drugs from three companies as part of a broader initiative to increase access to mental-health treatments. Compass Pathways will rece…
    STAT · 6mo agoRegulatoryPositive↗ source
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  • Utah medical board urges halt to AI-driven prescription renewal pilot
    Utah launched a pilot program that partners with AI startup Doctronic to let a chatbot conduct clinical evaluations and automatically renew prescriptions for roughly 200 medications, without direct…
    STAT · 6mo agoRegulatoryNegative↗ source
  • Avalyn Pharma targets $182M IPO as WHO prequalifies Novartis malaria drug
    Avalyn Pharma announced plans for an initial public offering that could raise about $182 million in net proceeds. The company is developing inhaled formulations of drugs already approved for pulmon…
    Endpoints · 6mo agoDealNeutral↗ source
  • Novartis withdraws EU filing for Pluvicto label expansion into early-stage prostate cancer
    Novartis announced it has pulled its application to the European Medicines Agency to extend the label of its radioligand therapy Pluvicto for use in earlier stages of prostate cancer. The move com…
    Endpoints · 6mo agoRegulatoryNegative↗ source
  • Trump announces drug pricing deal with Regeneron, completing White House's 17-deal target
    President Trump announced a drug‑pricing agreement with Regeneron Pharmaceuticals, marking the final deal in the administration's goal of securing 17 pricing arrangements. The agreement is intende…
    STAT · 6mo agoDealPositive↗ source
  • Sanofi's multiple sclerosis drug, previously rejected by FDA, receives positive recommendation from European regulators
    Sanofi's multiple sclerosis drug, which the U.S. FDA turned down late last year, has now been reviewed by European authorities. The European regulators issued a positive recommendation today, sugg…
    STAT · 6mo agoRegulatoryPositive↗ source
  • White House signs executive order to expand access to psychedelic therapies
    President Trump signed an executive order aimed at increasing the availability of psychedelic drug treatments. The order was announced alongside podcaster Joe Rogan, who said he had messaged the pr…
    STAT · 6mo agoRegulatoryPositive↗ source
  • FDA grants fast-track vouchers to three psychedelic firms
    The FDA announced it has issued fast-track development vouchers to three companies working on psychedelic therapies. The recipients are R&DCompass, Transcend, and the Usona Institute. The vouchers…
    Endpoints · 6mo agoRegulatoryPositive↗ source
  • UC Berkeley spinout explores gene-editing approach to GLP-1 based weight-loss therapy
    UC Berkeley researchers have launched a startup that plans to use jumping genes to deliver GLP-1 gene therapy for obesity treatment. The approach seeks to create a long-lasting source of the hormon…
    Endpoints · 6mo agoNeutral↗ source
  • Guest-edited journal issues face mass retractions over compromised peer review
    A recent retraction by the British Medical Journal’s publishing group removed almost an entire special issue of the Journal of Medical Genetics that focused on cancer immunotherapies. The journal…
    STAT · 6mo agoNegative↗ source
  • International childhood vaccine campaign expands, newsletter reports
    The latest Morning Rounds newsletter notes that a global campaign to increase childhood vaccination rates is gaining momentum. The piece highlights the growing reach of the effort without providing…
    STAT · 6mo agoNeutral↗ source
  • Daiichi Sankyo delays release of annual results, shares fall
    Daiichi Sankyo announced it will postpone the reporting of its annual results, saying more time is needed to finalize the numbers. The company had planned to unveil the financials for its fiscal y…
    Endpoints · 6mo agoNegative↗ source
  • Pfizer strategy chief Andrew Baum departs, stays on as senior advisor; Helus Pharma appoints new CEO after two months
    Andrew Baum, formerly chief strategy and innovation officer at Pfizer, has left that role. He will continue to work with the company as a senior strategic advisor to CEO Albert Bourla. Meanwhile,…
    Endpoints · 6mo agoNeutral↗ source
  • Tenpoint Therapeutics appoints Stephen Lane as chief medical officer
    STAT+ columnist Ed Silverman highlights recent personnel moves in the pharma sector. This week’s note focuses on a new senior appointment at Tenpoint Therapeutics. The company has hired Stephen La…
    STAT · 6mo agoNeutral↗ source
  • Local news shutdown threatens health reporting, but Pittsburgh Post-Gazette finds a lifeline
    The decline of local news outlets is eroding the coverage of health and science topics that communities rely on for accurate information. In early January, the Pittsburgh Post-Gazette, Western Pen…
    STAT · 6mo agoNegative↗ source
  • Veteran neonatal nurse practitioner begins medical school at 69 and prepares for family-medicine residency at 72
    Dawn Zuidgeest-Craft, a 69-year-old, is about to begin medical school after a career spanning more than four decades as a neonatal nurse practitioner. She aims to complete her training and start a…
    STAT · 6mo agoPositive↗ source
  • Regeneron secures first FDA approval for gene therapy treating rare inherited hearing loss
    Regeneron announced that the U.S. Food and Drug Administration has approved its gene-based treatment Otarmeni, marking the first approval of a therapy for inherited hearing loss. The therapy is de…
    Endpoints · 6mo agoApprovalPositive↗ source
  • Novo Nordisk's GLP-1 pill shows blood-sugar reduction in teens with type 2 diabetes
    Novo Nordisk reported results from a study evaluating its oral GLP-1 therapy, Rybelsus, in adolescents with type 2 diabetes. The trial enrolled participants aged 10-17 who took the pill for roughl…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Roche remains bullish on giredestrant despite first-line trial setback
    Roche's CEO Thomas Schinecker said the company still expects its investigational oral breast cancer therapy giredestrant to generate strong sales, potentially surpassing Herceptin. The optimism fo…
    Endpoints · 6mo agoNegative readoutNeutral↗ source
  • Trump touts completion of first round of White House drug pricing deals with Regeneron
    President Trump announced that a pricing agreement with Regeneron marks the final deal of an initial slate of 17 sought by the administration. Under the private arrangement, Regeneron will lower Me…
    STAT · 6mo agoDealNeutral↗ source
  • Trump administration allocates $50 million to psychedelic research and moves to downgrade medical marijuana
    President Trump signed an executive order that earmarks $50 million for research into psychedelics as potential mental‑health treatments and directs the FDA to accelerate their review process. The…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Novartis' Lutathera radioligand therapy may soon face first generic challenger
    Novartis has built a sizable business delivering radioligand therapies, with Lutathera being a leading product. A rival company is preparing to launch the first generic version, which could introd…
    Endpoints · 6mo agoNegative↗ source
  • Sanofi’s research focus may shift under new CEO Belén Garijo, amid gene therapy advances and telehealth debates
    Sanofi is entering a period of strategic reassessment as Belén Garijo assumes the chief executive role. Observers are watching to see whether the company will adjust its recent emphasis on immunolo…
    STAT · 6mo agoNeutral↗ source
  • Amneal to acquire biosimilar maker for $375 million upfront
    Amneal Pharmaceuticals announced it will purchase a biosimilar development company, agreeing to pay $375 million in an upfront cash payment. The deal expands Amneal’s portfolio in the growing biosi…
    Endpoints · 6mo agoDealNeutral↗ source