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  • 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
  • Xaira Therapeutics details its generative AI antibody platform X-Design and unveils first pipeline candidates
    Xaira Therapeutics, which raised $1 billion in 2024, has now shared details of its AI-driven antibody design platform called X-Design and provided a glimpse of its emerging pipeline. The company s…
    Fierce Biotech · 1mo agoPositive↗ source
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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
  • Abbott begins U.S. sales of SimpleScreen CRC, an FDA-approved blood test for average-risk colorectal cancer screening
    Abbott has started commercial sales in the United States of SimpleScreen CRC, a blood‑based test cleared by the FDA for colorectal cancer screening in adults 45 years and older who are at average r…
    Fierce Biotech · 1mo agoPositive↗ 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
  • Gate CEO sees expanded $870M pact with Lilly as ‘vote of confidence’ in biotech’s platform
    Eli Lilly has been pushing at an open door by tacking on $870 million in biobucks to its existing collaboration with Gate Bioscience.
    Fierce Biotech · 1mo agoDealNeutral↗ 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
  • Key criteria for selecting a biologics CDMO: reliability, cost, technology and partnership fit
    Choosing the right contract development and manufacturing organization is a strategic move for biotech and biopharma firms, as it can speed development and lower regulatory risk. The top priority…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Immunotherapy startup Adecto shuts down, citing risk-averse funding climate
    Adecto Pharmaceuticals, a Boston-based immunotherapy biotech founded in 2014 by Tufts researchers, announced it is closing after 12 years. The company had been developing AD100, a monoclonal antib…
    Fierce Biotech · 1mo agoNegative↗ source
  • Novartis bets up to $7.8B for an mRNA-encoded T cell engager from China’s Abogen
    Novartis is licensing an mRNA-based therapy designed to produce a CD3xCD19 T cell engager inside the body. Abogen Biosciences says the in vivo approach could reduce the likelihood of dangerous cyto…
    BioSpace · 1mo ago↗ source
  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 1mo agoApprovalPositive↗ source
  • Sanofi to pay $1 billion upfront to expand antibody partnership with Regeneron
    Sanofi announced it will provide Regeneron with a $1 billion upfront payment to broaden their existing antibody collaboration. The agreement is timed as the patent protection for Dupixent, the joi…
    Endpoints · 1mo agoDealNeutral↗ source
  • Sanofi pays Regeneron $1 billion upfront to co-develop four early-stage immunology assets
    Sanofi has agreed to pay Regeneron an upfront fee of $1 billion to partner on four early‑stage immunology programs, a move intended to capture the success of their joint Dupixent antibody. Dupixen…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • BMS flags liver injury cases, including a death, in Phase 3 trial of pulmonary fibrosis drug admilparant
    Bristol Myers Squibb has amended the protocol for its Phase 3 pulmonary fibrosis study of admilparant after reporting several liver injury events, one of which resulted in a patient death. The comp…
    BioSpace · 1mo agoNegative↗ source