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  • 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 · 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
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  • 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
  • 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
  • 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
  • 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
  • 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 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
  • Roche Diagnostics unveils single-assay newborn test for SMA, SCID and Sickle Cell Disease
    Roche Diagnostics introduced a new in‑vitro diagnostic kit called LightMix Newborn TREC/SMN1/HBB that can screen newborns for three rare genetic disorders in a single test. The assay simultaneousl…
    Fierce Biotech · 1mo agoPositive↗ source
  • Foghorn Therapeutics cuts 40% of staff after Lilly partnership ends over weak phase-1 data
    Foghorn Therapeutics announced it will lay off 40% of its workforce after its long‑standing collaboration with Eli Lilly fell apart due to disappointing phase‑1 trial results. The partnership, lau…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source
  • Zealand Pharma shares tumble 12% after Boehringer obesity drug trial meets endpoints but disappoints analysts
    A phase 3 trial of Boehringer Ingelheim's dual‑agonist drug survodutide in people with obesity and type 2 diabetes was presented at the European Association for the Study of Diabetes meeting in Mil…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • HHS unveils ARPA-H SURPASS program to accelerate clinical trial design
    On Oct 1, 2026 the U.S. Department of Health and Human Services announced a new initiative under the Advanced Research Projects Agency for Health. The initiative, named the Simulation-augmented, R…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EU Council adopts new pharma package to modernize drug legislation
    The Council of the European Union has approved a comprehensive "pharma package" of rules aimed at updating the regulatory framework for medicines across the bloc. The new legislation seeks to stre…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Foghorn Therapeutics cuts 40% of workforce after ending Lilly oncology partnership
    Foghorn Therapeutics and Eli Lilly announced the end of their 2021 oncology collaboration. The partnership had focused on developing and commercializing cancer treatments. Following the terminatio…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • FDA issues warning letter to Fresenius Kabi over famotidine injection contamination
    FDA inspectors spent three weeks at Fresenius Kabi's plant in Melrose Park, Illinois, and issued a warning letter after finding manufacturing deviations linked to patient adverse events. The issue…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Zealand Pharma shares fall as Boehringer Ingelheim partnership weight-loss drug shows modest 9.8% loss in Phase 3
    Zealand Pharma and its partner Boehringer Ingelheim reported that their glucagon/GLP-1 dual agonist survodutide met the primary endpoints in the Phase 3 SYNCHRONIZE-2 trial, but the magnitude of we…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • US government unveils AI-driven SURPASS program to accelerate clinical trials
    The U.S. Department of Health and Human Services announced that the Advanced Research Projects Agency for Health (ARPA-H) is launching four new initiatives aimed at modernizing clinical trial desig…
    BioSpace · 1mo agoRegulatoryPositive↗ source