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  • Kodiak Sciences reports Phase 3 success for Zenkuda, matching Eylea in wet AMD
    Kodiak Sciences announced that its experimental therapy Zenkuda achieved comparable efficacy to the market‑leading anti‑VEGF drug Eylea in a late‑stage trial for wet age‑related macular degeneratio…
    Endpoints · 23d agoPositive readoutPositive↗ source
  • AbbVie receives FDA approval for Parkinson’s drug Juvmo, a Cerevel acquisition asset
    AbbVie has secured FDA approval for tavapadon, marketed as Juvmo, for the treatment of Parkinson’s disease in adults. The decision follows positive results from the Phase 3 TEMPO trial. In the piv…
    BioSpace · 23d agoApprovalPositive↗ source
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  • Kodiak Sciences' zenkuda and tabirafusp-ted match Eylea in Phase 3, sending stock up 166%
    Kodiak Sciences announced Phase 3 results for two investigational eye‑disease drugs, zenkuda (anti‑VEGF antibody biopolymer conjugate) and tabirafusp‑ted (anti‑IL‑6/VEGF bispecific), which performe…
    BioSpace · 23d agoPositive readoutPositive↗ source
  • Mirum receives FDA approval for Atebrioz, third therapy for ultra-rare bone disease FOP
    Mirum Pharmaceuticals announced that the U.S. Food and Drug Administration approved its ALK2 inhibitor, zilurgisertib, to be marketed as Atebrioz, for the treatment of fibrodysplasia ossificans pro…
    BioSpace · 23d agoApprovalPositive↗ source
  • Merck signs up to $2.13 billion deal with SciBrunch for preclinical KRAS inhibitor SPR2015
    Merck announced it has completed a deal with Chinese biotech SciBrunch Therapeutics, paying $400 million upfront for exclusive global rights to develop, manufacture and commercialize SciBrunch’s pr…
    BioSpace · 23d agoDealPositive↗ source
  • Novo Nordisk rebrands GLP-1 therapy Wegovy as weight-loss product, positioning it as lifestyle drug
    GLP-1 drugs have transformed the lives of millions and were originally promoted as medicines for obesity, a medical condition. Recent advertising campaigns are now presenting these drugs as genera…
    STAT · 24d agoNeutral↗ source
  • Nonprofits launch ultra-rare immune disease gene therapy Waskyra at $3.25 million price
    Two nonprofit organizations have received FDA approval for a gene therapy that targets an ultra-rare immune disorder. The therapy, called Waskyra, is now being launched with a list price of $3.25…
    Endpoints · 23d agoApprovalNeutral↗ source
  • Rising health insurance premiums and a private equity hospital chain's shift to nonprofit highlight bleak outlook for US healthcare costs
    Bob Herman's latest Health Care Inc. newsletter warns that employer-sponsored health insurance is becoming increasingly unaffordable, with premiums climbing sharply. The piece cites a series called…
    STAT · 23d agoNegative↗ source
  • Merck and Daiichi Sankyo pull accelerated approval request for lung cancer ADC
    Merck and Daiichi Sankyo have voluntarily withdrawn their application for accelerated approval of the antibody-drug conjugate ifinatamab deruxtecan. The FDA indicated that the data package did not…
    BioSpace · 24d agoRegulatoryNegative↗ source
  • Ultragenyx gains FDA approval for Fayuvi, a Sanfilippo syndrome A therapy, easing impact of recent Angelman setback
    Ultragenyx announced that the FDA has approved its drug Fayuvi for treating Sanfilippo syndrome type A, a rare neurodegenerative condition affecting children. The approval marks the company's first…
    BioSpace · 24d agoApprovalPositive↗ source
  • AstraZeneca invests $2 billion for stake in Summit Therapeutics to back its cancer drug
    AstraZeneca announced on Monday that it will invest $2 billion to acquire a minority equity stake in Summit Therapeutics. The investment gives AstraZeneca a slice of the biotech as the companies mo…
    Endpoints · 23d agoDealPositive↗ source
  • FDA to review and potentially overhaul PMTA rules amid lawsuit and illicit market concerns
    FDA announced it is reviewing its experience with the Premarket Tobacco Product Application (PMTA) rule and recent court actions. The agency cites the growth of an illicit market and rapid introdu…
    fda press · 23d agoRegulatoryNeutral↗ source
  • Mirum reports Phase 3 success for its acquired hepatitis D therapy
    Mirum Pharmaceuticals announced that its recently acquired chronic hepatitis delta drug met its primary endpoint in a Phase 3 trial. The study tested a once-weekly 300 mg injection, and more than…
    Endpoints · 23d agoPositive readoutPositive↗ source
  • White House seeks data on U.S. manufacturing of 86 essential medicines
    The White House Office of Management and Budget has launched a review of domestic production for a list of 86 medicines deemed essential. The request asks manufacturers to provide information on w…
    Endpoints · 23d agoRegulatoryNeutral↗ source
  • Merck licenses KRAS G12D inhibitor from Tao Hu for $400 million upfront
    Merck has signed a licensing agreement for a KRAS G12D inhibitor, providing an upfront payment of $400 million. The deal follows a 2023 transaction in which the same entrepreneur, synthetic chemis…
    Endpoints · 23d agoDealNeutral↗ source
  • AbbVie’s once-daily Parkinson’s pill receives FDA approval
    AbbVie announced that the U.S. Food and Drug Administration has granted approval for its once‑daily oral therapy for Parkinson’s disease. The decision allows the product to be marketed in the Unite…
    STAT · 23d agoApprovalPositive↗ source
  • GLP-1 drugs shift from obesity treatment to lifestyle products, prompting setbacks for Merck and Daiichi
    The column notes that GLP-1 medicines, originally marketed to treat obesity as a medical condition, are now being promoted more as general lifestyle enhancers for appearance and wellbeing. Novo No…
    STAT · 23d agoNegative↗ source
  • AI tools that aid vaccine design could also accelerate creation of bioweapons, warns former White House Covid adviser
    Ashish K. Jha, a former White House Covid‑19 response coordinator and senior fellow at Harvard Kennedy School, cautions that artificial intelligence is lowering the barriers that kept biological we…
    STAT · 24d agoNegative↗ source
  • Biopharma chases new immunology targets as Humira and Dupixent set high bar
    Johnson & Johnson, Pfizer, Argenx and several other companies are expanding their immunology pipelines, seeking new targets and improvements to capture part of the market driven by AbbVie’s Humira…
    BioSpace · 24d agoPositive↗ source
  • Adicet Bio reports early CAR-T therapy improves lupus symptoms, plans pivotal trial as shares fall
    Adicet Bio said its off-the-shelf CAR-T cell therapy showed signs of efficacy in a small early-stage trial involving patients with systemic lupus erythematosus. The study reported measurable impro…
    Endpoints · 23d agoPositive readoutNeutral↗ source
  • Scynexis secures $200M+ BARDA contract for investigational antifungal SCY-247
    Scynexis announced a partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) that provides more than $200 million to advance SCY-247, an experimental therapy aimed…
    Endpoints · 23d agoDealPositive↗ source
  • Trump administration pulls nearly $1 billion from HHS programs for immigrants and diversity
    The White House announced a reversal of almost $1 billion in spending that Congress had previously approved for the Department of Health and Human Services. The reduction was made late on Friday ni…
    STAT · 23d agoRegulatoryNegative↗ source
  • Merck and Daiichi withdraw FDA accelerated approval filing for B7-H3 ADC in small cell lung cancer
    Merck and Daiichi Sankyo announced they have withdrawn their joint FDA accelerated approval filing for a B7-H3 antibody-drug conjugate intended for a subset of small cell lung cancer patients. The…
    Endpoints · 24d agoRegulatoryNegative↗ source
  • Roche halts development of muscle-preserving obesity drug and returns program to Chugai
    Roche announced it is ending work on the experimental muscle-building compound known as GYM329, which had been tested together with a GLP-1 based anti-obesity injection. The decision stops the ong…
    Endpoints · 23d agoNegative↗ source
  • Study finds toxic metal exposure persists months after Maui wildfires
    University of Hawai‘i researchers examined urine samples from about 1,400 adults as part of the Maui Wildfire Exposure Study, one of the nation’s largest investigations of post‑fire health effects.…
    STAT · 23d agoNegative↗ source