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2,044 stories matching this filter · ← front page

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  • Mimetic Medicines' peptide reduces pain-related sodium channels in mice, offering new neuropathic pain strategy
    Researchers at Mimetic Medicines tested a short lipidated peptide (SLiP) in mice and found it lowered the presence of Nav1.8 sodium channels on sensory neuron membranes. Reducing these channels hel…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • ICU Medical updates IV tubing set instructions after reports of black specks in drip chambers
    ICU Medical has issued a final update letter recommending revised use instructions for several of its IV tubing sets after reports of black specks and particulate matter in the drip chambers. The…
    fda medwatch · 16d agoRegulatoryNeutral↗ source
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  • 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 · 16d 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 · 16d agoNegative↗ 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 · 16d ago↗ source
  • Novartis signs $7.8 billion deal with Abogen for mRNA-encoded autoimmune T-cell engager
    Novartis announced it will pay $575 million upfront to Abogen Biosciences for an mRNA-encoded T-cell engager that has shown early clinical activity in autoimmune disease. The agreement includes up…
    Fierce Biotech · 19d agoDealNeutral↗ source
  • Novartis pays $575 million upfront for access to Chinese biotech Abogen’s RNA platform and option on ABO-2203
    Novartis announced a deal with China‑based Abogen Biosciences that could be worth up to $7.8 billion. The agreement includes an upfront payment of $575 million. Under the deal, Abogen will provide…
    BioPharma Dive · 19d agoDealPositive↗ source
  • Kodiak Sciences' Zenkuda shows non-inferior six-month dosing vs Eylea, shares double
    Four years ago Kodiak Sciences saw its share price plunge about 80% after its lead eye-disease candidate failed a head-to-head trial against Regeneron's Eylea, wiping out roughly $2 billion in mark…
    BioPharma Dive · 19d agoPositive readoutPositive↗ 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 · 19d 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 · 19d agoPositive↗ 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 · 19d 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 · 19d agoDealPositive↗ 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 · 19d agoPositive readoutPositive↗ 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 · 19d 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 · 19d 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 · 19d agoDealNeutral↗ source
  • Draeger recalls VentStar Resus Neo hoses over crack risk
    Draeger has issued a Class I recall for its VentStar Resus Neo breathing circuit hoses after discovering that some hoses can develop cracks or become detached. The company sent a letter to custome…
    fda medwatch · 19d agoCRLNegative↗ 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 · 19d 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 · 19d 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 · 19d 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 · 19d ago↗ 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 · 20d agoDealPositive↗ source
  • Eli Lilly, Novo, AbbVie and Boehringer showcase new obesity drug data at European meeting
    The European Association for the Study of Diabetes held its annual meeting in Milan, drawing obesity and metabolic disease experts and providing a platform for drugmakers to present emerging weight…
    BioPharma Dive · 20d agoPositive readoutPositive↗ source
  • Sanofi, Regeneron expand partnership with $1 billion deal to develop next-generation Dupixent-like antibodies
    Sanofi and Regeneron announced they have broadened their long‑standing alliance, adding a $1 billion upfront payment to fund joint work on new immune‑modulating drugs. The revised agreement calls…
    BioPharma Dive · 20d agoDealPositive↗ source
  • Pfizer's experimental eczema drug tilrekimig shows strong skin clearance in Phase 2 trial
    Pfizer reported that its three‑pronged antibody, tilrekimig, met the primary endpoint of its Phase 2 study in patients with moderate to severe atopic dermatitis. After 16 weeks, a significantly hig…
    BioPharma Dive · 20d agoPositive readoutPositive↗ source