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  • WHO releases updated draft guideline to strengthen quality risk management for manufacturers and regulators
    The World Health Organization has issued an updated draft guideline designed to help manufacturers establish effective quality risk management systems and to aid regulators in planning inspections.…
    raps · 15d agoRegulatoryNeutral↗ source
  • Nuvig Therapeutics pauses CIDP trial of NVG-2089, cites enrollment and cost challenges
    Nuvig Therapeutics, backed by major pharmaceutical partners, announced it is stopping development of its lead fusion protein NVG-2089 for chronic inflammatory demyelinating polyradiculoneuropathy (…
    Fierce Biotech · 14d agoNegative↗ source
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  • FDA approves first expandable pediatric pulmonary heart valve
    The FDA has cleared a new surgically implanted pulmonary valve designed for children with congenital pulmonary valve disease. The device, called the Autus Size-Adjustable Valve, was developed by E…
    Fierce Biotech · 16d agoApprovalPositive↗ source
  • Vaxcyte’s 31-valent pneumococcal vaccine shows non-inferior immunity to Pfizer and Merck shots in Phase 3, shares surge
    Vaxcyte’s 31-valent pneumococcal candidate, VAX-31, was compared head‑to‑head with Pfizer’s Prevnar 20 and Merck’s Capvaxive in the late‑stage Opus‑1 study aimed at preventing invasive pneumococcal…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • CSL pays $355M upfront to co-develop Alentis’ phase-2 fibrosis drug lixudebart
    CSL of Australia has agreed to pay $355 million upfront for the rights to Alentis Therapeutics' anti-Claudin-1 drug lixudebart, a phase-2 fibrosis candidate. The agreement includes up to $1.2 bill…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Genmab’s Rina-S ADC shows 9.5-month median PFS, touted as superior to AbbVie’s Elahere
    Genmab reported median progression‑free survival of 9.5 months for its FRα‑directed antibody‑drug conjugate Rina‑S in part C of the phase 1/2 Rainfol‑01 trial, which enrolled 109 patients with plat…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • Scientists awarded 2026 Nobel Prize for pioneering optogenetics light-switch technique
    The 2026 Nobel Prize in Physiology or Medicine was awarded to Karl Deisseroth, Peter Hegemann and Georg Nagel for their work on optogenetics, a technique that uses light to control neurons. The me…
    Fierce Biotech · 16d agoPositive↗ source
  • Genentech pays Alector $100M for preclinical Parkinson’s prospect
    Genentech is paying Alector $100 million upfront for exclusive rights to a preclinical drug candidate that targets a driver of neurodegeneration in Parkinson’s disease.
    Fierce Biotech · 16d agoDealNeutral↗ source
  • FDA warns Evolus over misleading Instagram claims about Jeuveau
    The FDA's Office of Prescription Drug Promotion sent an untitled warning letter to Evolus, the maker of the injectable cosmetic product Jeuveau. The letter says the company exaggerated the drug’s…
    raps · 16d agoRegulatoryNegative↗ source
  • 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 · 16d 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 · 16d agoRegulatoryNeutral↗ source
  • 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
  • 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 · 16d 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 · 16d agoRegulatoryNeutral↗ 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
  • 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
  • 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 · 18d 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 · 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
  • 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 · 19d 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 · 20d agoDealPositive↗ 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 · 20d agoPositive↗ source