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  • 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 · 1mo 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 · 1mo agoPositive readoutPositive↗ source
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  • 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 · 1mo 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 · 1mo agoDealNeutral↗ 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 · 1mo 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 · 1mo 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 · 1mo agoDealPositive↗ 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
  • 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
  • Regenerative medicine requires diagnostics and product characterization beyond stem cell basics
    Stem cell therapies are often portrayed as a single treatment, but they actually vary widely in tissue source, cell passage, viability and delivery methods. Experts say a credible regenerative app…
    BioSpace · 1mo agoNeutral↗ source
  • BioSpace report examines factors driving employee engagement in life sciences firms
    BioSpace released a new report titled "What Powers Employee Engagement" that looks at what influences staff morale in the life‑science sector. The study draws on data from the 2027 Best Places to…
    BioSpace · 1mo agoNeutral↗ 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
  • 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
  • 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
  • Genentech signs $55M upfront deal with AI firm Earendil Labs to develop bispecific cancer antibodies, potential total value over $1.5B
    Genentech announced a partnership with AI‑driven Earendil Labs that includes a $55 million upfront payment and could exceed $1.5 billion when development, regulatory and sales milestones are met. T…
    BioSpace · 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
  • Carvykti shows 5-year survival in half of multiple myeloma patients in Phase 2 study
    Johnson & Johnson and Legend Biotech reported that 10 of the 20 multiple myeloma patients treated with a single dose of Carvykti remained alive after a median follow‑up of 60.7 months, representing…
    BioSpace · 1mo agoPositive readoutPositive↗ 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
  • Experts say expanding beyond rare disease markets can make ultra-rare therapies financially viable
    The piece highlights that investment in ultra‑rare disease treatments remains limited, and experts argue the answer is not to focus solely on the rare condition itself. They propose that drugmaker…
    Endpoints · 1mo agoPositive↗ source
  • Biomanufacturers Redesign Processes to Blend Emergency Vaccine Readiness with Commercial Flexibility
    Manufacturers are overhauling their production methods to simultaneously improve rapid vaccine deployment for future health crises and maintain flexible, commercially viable manufacturing networks…
    BioSpace · 1mo agoNeutral↗ source
  • NewLimit raises $682M to pursue new class of anti-aging drugs
    NewLimit, a biotech startup based in South San Francisco, announced it secured $682 million in funding. The round was led by venture firms including Kleiner Perkins, Founders Fund, Dimension Capit…
    Endpoints · 1mo agoDealPositive↗ source