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  • Bayer to invest $2.2B in new Ohio manufacturing complex as FDA CDER opens clinical trial modernization office
    Bayer announced plans to spend roughly $2.2 billion on a new manufacturing site in Ohio, aiming to broaden its production capabilities. The investment is projected to increase capacity and generat…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA Requests Public Feedback on Designing Early-Phase Trials for Psychedelic Drug Ibogaine
    The U.S. Food and Drug Administration announced it is seeking comments from the public on how to structure early-phase clinical studies of ibogaine, a plant-derived psychoactive compound. The agen…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • Genentech parts ways with global AI head Richard Bonneau
    Genentech, the Roche biotech unit, announced that its global head of artificial intelligence for drug discovery, computational biologist Richard Bonneau, has left the company effective immediately.…
    Endpoints · 1mo agoNegative↗ source
  • FDA issues request for information on early-phase ibogaine trial design
    The FDA announced a request for information (RFI) to gather input on how to design early-phase clinical trials of ibogaine drug products. The agency is looking for comments on protocol elements su…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Australia's TGA begins five-year transition to new medicine labeling standards
    The Therapeutic Goods Administration has adopted two new labeling standards for medicines in Australia. The standards will become mandatory after a five-year transition period that starts now. Ph…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Two Massachusetts biotech firms shut down, ending cancer and eye‑disease programs
    Adecto Pharmaceuticals, a Boston‑based biotech developing a treatment for cancers resistant to standard immunotherapy, announced it has ceased operations as of September 30. CEO Nora Minerva shared…
    BioSpace · 1mo agoNegative↗ source
  • Report highlights 20 women reshaping biopharma across oncology and rare disease fields
    The 2026 special report spotlights twenty women who are driving change in biopharma, covering areas such as oncology and rare diseases. The series, now in its eighth year, has recognized over 160…
    Endpoints · 1mo agoPositive↗ source
  • Weighing the risks of CAR T in autoimmune disease as Kyverna nears market
    Not a month after reports of three deaths in autoimmune trials for Novartis' CAR T cell therapy ignited a debate about the use of these treatments in nonfatal diseases, Kyverna Therapeutics reporte…
    BioSpace · 1mo ago↗ source
  • Eli Lilly reports strongest weight-loss data yet; Sanofi and Regeneron secure $1 billion upfront deal
    The weekly Endpoints newsletter dated October 3, 2026 highlights that Eli Lilly's latest weight‑loss trial produced its best‑ever results. While the article does not provide specific numbers, the…
    Endpoints · 1mo agoDealNeutral↗ source
  • BMO sees Merck better positioned than BMS to handle looming patent cliffs
    BMO Capital Markets says Merck has a stronger plan than Bristol Myers Squibb to replace revenue lost to upcoming patent expirations. The firm highlights Merck's pipeline as more derisked and sizabl…
    BioSpace · 1mo agoNeutral↗ source
  • Novartis pays $575 million upfront for worldwide rights to Abogen’s CD19xCD3 mRNA T-cell engager
    Novartis announced it will pay Abogen Biosciences $575 million upfront for exclusive worldwide rights to its lead early‑stage CD19xCD3 mRNA T‑cell engager. The agreement gives Novartis access to t…
    Endpoints · 1mo agoDealPositive↗ source
  • Bayer outlines $2.2 billion Ohio plant that will add roughly 600 jobs
    Bayer announced its plan for a new manufacturing complex in New Albany, Ohio, with an investment of about $2.2 billion. The facility is expected to create roughly 600 new jobs in the region, suppo…
    Endpoints · 1mo agoPositive↗ source
  • Aviceda Therapeutics to wind down after Phase 2 failure in geographic atrophy program
    Aviceda Therapeutics, a biotech focused on geographic atrophy, announced it is winding down operations. The decision follows a Phase 2 trial that did not meet its endpoints, halting plans to move…
    Endpoints · 1mo agoNegative↗ source
  • FDA launches new office in CDER to modernize clinical trials
    The FDA announced the creation of a new office within its Center for Drug Evaluation and Research (CDER) dedicated to modernizing clinical trials. The office aims to accelerate the design and exec…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Eli Lilly signals entry into aesthetics market with plans to acquire skin, body and hair treatments
    Eli Lilly is indicating an interest in expanding into the aesthetics sector, according to a recent job posting. The company appears to be seeking opportunities to add products that address skin agi…
    Endpoints · 1mo agoNeutral↗ source
  • Sarepta's Elevidys shows durable benefit in ambulatory Duchenne patients, analysts see turnaround potential
    Jefferies analysts said Sarepta Therapeutics could become a turnaround story after the company presented new data on its Duchenne muscular dystrophy gene therapy Elevidys. The late-breaking poster…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Varda Space Industries secures $251 million to produce drugs in microgravity
    Varda Space Industries, a startup partnered with United Therapeutics, announced a $251 million Series D financing round. The funding, led by Lux Capital and Natural Capital, brings total capital r…
    BioSpace · 1mo agoDealPositive↗ source
  • Researchers claim small molecules could reprogram cells, hinting at a future anti‑aging pill
    Scientists have identified tiny compounds that appear to reset cells to a more youthful condition, according to a recent report featuring David Sinclair’s lab. The molecules work by altering cellul…
    Endpoints · 1mo agoPositive↗ source
  • Kailera and Hengrui’s GLP-1/GIP candidate ribupatide cuts weight up to 20% and restores menstrual cycles in Phase 2 PMOS trial
    Kailera Therapeutics and Hengrui Pharma reported positive results from a Phase 2 study of their weekly injectable GLP-1/GIP dual agonist, ribupatide, in women with polyendocrine metabolic ovarian s…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Regeneron explores pairing its obesity drug with lipid-lowering therapy to differentiate in crowded GLP-1 market
    The pipeline of GLP-1 based medicines is delivering increasingly strong weight-loss results, prompting many companies to seek ways to stand out as the market fills. Regeneron said it is looking at…
    Endpoints · 1mo agoPositive↗ source
  • Moderna appoints former executive Juan Andres as COO as Neurocrine reshuffles leadership; Pharming CEO steps down after board dispute
    Juan Andres, a former Moderna executive, will return from retirement to assume the role of chief operating officer on Oct. 5. His deep familiarity with the company is seen as valuable as Moderna ad…
    Endpoints · 1mo agoNeutral↗ source
  • FDA device center outlines FY 2027 guidance agenda, focusing on AI devices and change control plans
    The FDA's Center for Devices and Radiological Health announced its guidance priorities for fiscal year 2027 on Oct 1. The top items are finalizing guidance on artificial intelligence‑enabled medic…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Summit Therapeutics partners with AstraZeneca and Daiichi Sankyo on cancer trial; Eccogene hits $50 million milestone
    Summit Therapeutics announced a partnership with AstraZeneca and Daiichi Sankyo to evaluate its Trop-2‑directed antibody‑drug conjugate in a clinical trial. The collaboration will involve joint de…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA device center outlines FY 2027 guidance plan, targeting AI-enabled devices and change-control plans
    On Oct 1, the FDA’s Center for Devices and Radiological Health announced its guidance agenda for fiscal year 2027. The top priority is finalizing guidance for artificial intelligence-enabled medic…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Stewart’s Shop Corp. Recalls Heavenly Medley and Vanilla-Chocolate-Strawberry Due to Possible Foreign Object
    October 2, 2026, Stewart’s Shops Corp. of Saratoga Springs, NY is recalling two flavors, Heavenly Medley and Vanilla-Chocolate-Strawberry, of half-gallon ice cream due to the potential presence of…
    fda recalls · 1mo agoRegulatoryNeutral↗ source