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  • UK regulator adopts AI framework for medical devices, launches next phase of AI sandbox
    The Medicines and Healthcare products Regulatory Agency announced that the UK government has accepted a set of recommendations on using artificial intelligence in medical devices. These recommendat…
    raps · 1mo agoRegulatoryPositive↗ source
  • Key Biopharma Conferences to Watch in 2027 Highlight Industry Trends
    The article lists major medical meetings slated for 2027 that serve as platforms for companies to present clinical data and network. Highlights include the J.P. Morgan Healthcare Conference in ear…
    BioPharma Dive · 1mo agoNeutral↗ source
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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 · 1mo 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 · 1mo agoNegative↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Vaxcyte's next-gen pneumococcal vaccine matches leading shots in Phase 3 trial
    Vaxcyte reported that its experimental pneumococcal vaccine, VAX-31, achieved its primary efficacy goals in the first of three Phase 3 studies. In adults aged 50 and older, the vaccine performed o…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Nobel Prize honors optogenetics pioneers; Roche licenses Alector’s Parkinson’s enzyme therapy
    The Nobel Committee awarded this year’s Physiology or Medicine prize to three scientists whose work created the field of optogenetics. Their discoveries of a light‑sensing protein in algae and its…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • 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 · 1mo agoApprovalPositive↗ source
  • Shionogi to acquire Texas-based IntraBio for $2 billion, adding marketed rare-disease drug Aqneursa
    Shionogi announced Monday it will buy IntraBio, a Texas biotech, for $2 billion in cash, making IntraBio a wholly owned subsidiary of its U.S. division. The deal gives Shionogi ownership of Aqneur…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • AI drives faster drug development and reshapes biopharma manufacturing facilities
    AI is speeding up the identification of drug candidates, turning years of laboratory work into months by analyzing large biological datasets and accelerating early‑stage development. This accelera…
    BioPharma Dive · 1mo agoPositive↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoDealNeutral↗ source
  • Diagnostic-driven therapies face patient loss due to workflow gaps, new commercialization model proposed
    The sponsored article from Diaceutics highlights that while diagnostic-driven therapies are being developed faster than ever, many patients who could benefit never receive them. The authors attribu…
    BioPharma Dive · 1mo agoNeutral↗ 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 · 1mo 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 · 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
  • 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 · 1mo agoPositive readoutPositive↗ 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
  • 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
  • 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 · 1mo 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 · 1mo agoPositive readoutPositive↗ 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