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  • Merck and Daiichi withdraw lung cancer ADC filing after FDA says data insufficient
    Merck and Daiichi Sankyo have pulled their application for accelerated approval of a B7-H3-directed antibody-drug conjugate aimed at extensive-stage small cell lung cancer. The FDA indicated that…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ 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 · 1mo agoPositive readoutNeutral↗ source
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  • 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 · 1mo 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 · 1mo 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    Merck and Daiichi Sankyo announced they have withdrawn their joint FDA accelerated approval filing for a B7-H3 antibody-drug conjugate intended for a subset of small cell lung cancer patients.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 · 1mo agoRegulatoryNegative↗ source
  • Operational talent, not just science, will drive next biopharma breakthroughs
    The piece points out that while breakthrough science, founders and venture funding are typical markers of progress, the real test is moving a promising therapy through GMP production, quality syste…
    BioPharma Dive · 1mo agoNeutral↗ 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 · 1mo 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 · 1mo agoNegative↗ source
  • Azurity urges simpler medicines for children to reduce daily burdens on families
    Azurity Pharmaceuticals published a sponsored article that looks at how chronic medicines can shape a child's daily routine. The piece points out that while clinical trials test drugs under strict…
    BioPharma Dive · 1mo agoPositive↗ source
  • Trump administration seeks Supreme Court stay on gender-affirming care restrictions in federal prisons
    The Trump administration filed an emergency petition with the Supreme Court asking it to pause a district judge’s order that requires continued provision of gender-affirming medical treatments to i…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Researchers identify previously unseen structure in the human heart
    An author of an opinion piece reports that a close visual inspection of the heart revealed a previously unrecognized anatomical structure. The discovery was made without new imaging technology, sim…
    STAT · 1mo agoPositive↗ source
  • FDA greenlights AbbVie’s next-generation Parkinson’s drug tavapadon (Juvmo) with expected lower side effects
    The U.S. Food and Drug Administration has approved AbbVie’s new therapy for Parkinson's disease, tavapadon, which will be marketed under the name Juvmo. Tavapadon is a dopamine agonist intended to…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Former CDC investigator warns that gaps in public-health readiness leave the U.S. vulnerable to future biothreats
    Daniel Jernigan, a former CDC scientist who helped investigate the 2001 anthrax mailings, reflects on the lessons learned two and a half decades later. The anthrax letters, sent from New Jersey to…
    STAT · 1mo agoNeutral↗ source
  • Endpoints Weekly returns with new class unveiled at Boston gala
    The newsletter marks the return of Endpoints Weekly, a regular briefing on pharmaceutical industry news. The latest edition introduced the "Endpoints 11" cohort during a gala event in Boston, and…
    Endpoints · 1mo agoNeutral↗ source
  • Trump administration cancels nearly $1 billion of congressional spending, targeting refugee and immigrant services
    The White House announced on Friday that it is using a rarely invoked authority to rescind almost $1 billion in funding that Congress had approved earlier. The cuts focus mainly on Health and Huma…
    STAT · 1mo agoNegative↗ source
  • FDA approves Lilly's once-weekly basal insulin Onswik for adults with type 2 diabetes
    The U.S. Food and Drug Administration has granted approval to Eli Lilly’s Onswik, a basal insulin designed for once-weekly injection in adults with type 2 diabetes. The new formulation offers patie…
    STAT · 1mo agoApprovalPositive↗ source
  • Merck's Welireg receives FDA nod for expanded use with Lenvima in kidney cancer
    Merck announced that its drug Welireg has received FDA approval for use together with Eisai's Lenvima in patients with advanced renal cell carcinoma. The clearance broadens the indication, allowin…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Adicet Bio's off-the-shelf CAR-T therapy shows lupus remission in early Phase 1 trial
    Adicet Bio reported that its off-the-shelf CAR-T product prula-cel induced remission in more than half of lupus patients enrolled in a small Phase 1 study. One year after a single infusion, 12 of…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • UN-backed agency secures sub-licensing deals for generic Roche flu drug across 129 low- and middle-income countries
    An agency supported by the United Nations has finalized sub-licensing contracts with eleven drug manufacturers to create generic versions of Roche’s influenza medication Xofluza. The agreements al…
    STAT · 1mo agoDealPositive↗ source
  • Novo’s stock tumbles after two-year GLP-1 boom as AI drug-discovery startups land huge funding rounds
    Novo’s shares, which peaked above $140 in June 2024 during a surge in demand for its GLP-1 drugs Ozempic and Wegovy, have fallen sharply over the past two years. The decline reflects a broader mark…
    BioPharma Dive · 1mo agoNegative↗ source
  • Azalea Therapeutics wins Endpoints 11 award, combines gene editing with CAR-T and raises $82 million
    Azalea Therapeutics was named the winner of the Endpoints 11 2026 competition, highlighting its innovative approach in the biotech space. The company’s platform merges precise gene‑editing techniq…
    Endpoints · 1mo agoDealPositive↗ source
  • Novo signs $1.3 billion deal with Nanexa to add long-acting injectables for obesity and diabetes
    Novo has entered a licensing agreement with Nanexa, valued at about 1.17 billion euros, to use Nanexa’s PharmaShell platform for its obesity and type‑2 diabetes medicines. The PharmaShell technolo…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Genentech signs $1.5 billion bispecific antibody deal with Earendil Labs
    Genentech, Roche's US subsidiary, announced a licensing agreement with Earendil Labs to discover and develop multiple bispecific antibodies aimed at oncology. The agreement provides a $55 million…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • RNAi biotech ADARx raises $446 million in IPO, secures $89 million from AbbVie
    ADARx Pharmaceuticals priced its initial public offering at $17 per share, selling more than 26 million shares to raise about $446.3 million. The company also received an additional $89 million th…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA approves Mirum's Atebrioz for ultra-rare disease that hardens muscle and connective tissue
    The U.S. Food and Drug Administration has granted approval for Mirum Pharmaceuticals' new therapy for an ultra-rare genetic disorder that causes muscle and connective tissue to turn into bone. The…
    Endpoints · 1mo agoApprovalPositive↗ source