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972 stories matching this filter · ← front page

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  • Roche licenses Rona's ALK7 obesity candidate in $1.2 billion deal
    Roche has agreed to license an RNAi drug candidate targeting ALK7 from Chinese biotech Rona Therapeutics, with an upfront payment of $100 million and potential milestones up to $1.06 billion. The…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Study urges regulators to adopt cloud platforms to speed drug approvals
    A new study led by Nina Cauchon of Amgen and co-authors, published in the Journal of Pharmaceutical Sciences, calls for broader use of cloud-based platforms by regulatory agencies. The authors arg…
    raps · 7d agoRegulatoryPositive↗ source
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  • Saudi Arabia signs 46 biotech agreements at Riyadh summit, targeting $1.5 bn investment
    The fourth Riyadh Global Medical Biotechnology Summit wrapped up on September 16, with 46 agreements signed among local and international participants. The disclosed agreements represent about 5.5…
    Fierce Biotech · 6d agoDealPositive↗ source
  • WCG launches AI-driven Activation Intelligence to speed clinical trial start-ups
    WCG, a provider of clinical trial solutions, announced a new AI-powered program called Activation Intelligence aimed at accelerating the start-up phase of studies. In early access, the tool report…
    Fierce Biotech · 6d agoPositive↗ source
  • Insulet launches full U.S. release of Omnipod Discover data platform for Omnipod 5 users
    Insulet announced that its Omnipod Discover platform is now fully available across the United States. The web-based service is built to work with the company’s Omnipod 5 automated insulin delivery…
    Fierce Biotech · 7d agoPositive↗ source
  • Stakeholders urge FDA to adopt flexible approach for psychedelic drug regulation
    Various individuals and groups have submitted comments urging the U.S. Food and Drug Administration to be flexible in regulating psychedelic medicines that could treat major depressive disorder and…
    raps · 7d agoRegulatoryNeutral↗ source
  • Roche signs $1.2B partnership with China’s Rona for obesity drug as Stryker pours $400M into CMR Surgical
    Roche has entered a $1.2 billion agreement with Chinese firm Rona to advance an obesity treatment, targeting the growing market for weight‑loss therapies in China. The deal will combine Roche’s dr…
    raps · 7d agoDealPositive↗ source
  • Paragon Labs hires former Apogee leadership after AbbVie acquisition and spins out hypertension unit
    Paragon Labs announced it has brought several former Apogee Therapeutics executives onto its senior team following AbbVie's $10.9 billion purchase of Apogee. The incoming leaders include Michael H…
    Fierce Biotech · 6d agoDealNeutral↗ source
  • Nurix halts development of BTK degrader zelebrudomide after phase 1 review
    Nurix announced it will discontinue clinical development of its BTK degrader zelebrudomide, also known as NX-2127, following completion of enrollment in a phase 1 trial for aggressive non‑Hodgkin l…
    Fierce Biotech · 7d agoNegative↗ source
  • BMS reports phase 3 successes in IPF drug and neuroendocrine tumor radiotherapy
    Bristol Myers Squibb announced that two of its phase 3 trials have met primary endpoints, marking important milestones as the company seeks growth beyond its patent expirations. The Aloft-IPF stud…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • Roche reports updated eye drug data and FDA filing acceptance, targets July 2027 decision
    Roche Genentech has presented new data from its eye disease trials, a year after a mixed Phase 3 readout, and noted that the FDA has accepted its filing for vamikibart with a decision slated for Ju…
    Fierce Biotech · 7d agoRegulatoryPositive↗ source
  • Tortugas Neuroscience's obuprazine shows significant improvement in phase 2b schizophrenia trial in China
    Tortugas Neuroscience, a biotech founded by former Sage Therapeutics staff with $106 million in funding, reported positive data from a phase 2b study of its schizophrenia candidate obuprazine, lice…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • FDA approves new treatments for persistent herpes and schizophrenia; Steris to acquire Xodus Medical for $2.1 billion
    The U.S. Food and Drug Administration has granted approvals for two new drugs, one targeting persistent herpes infections and another for the treatment of schizophrenia. The herpes indication addr…
    raps · 8d agoApprovalPositive↗ source
  • FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standards
    The U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
    raps · 8d agoRegulatoryNeutral↗ source
  • Merck’s deeper dive into efficacy, safety of $1.3B eye disease drug raises fears of ‘limited’ potential
    Merck & Co. has poured out its Brunello data, revealing a mix of undifferentiated efficacy and concerning safety that led analysts to predict “limited competitive potential” in diabetic macular ede…
    Fierce Biotech · 8d agoRegulatoryNeutral↗ source
  • Japan's PMDA Issues Guidance to Safeguard Participants in Generic Bioequivalence Trials
    The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released new guidance aimed at protecting healthy adult volunteers who take part in generic bioequivalence studies. The document…
    raps · 8d agoRegulatoryNeutral↗ source
  • Europe’s share of clinical trials falls 13.5% as Asia’s research footprint expands
    The latest data show a 13.5% drop in the number of clinical trials authorized in the EU and EEA compared with pre-pandemic levels. At the same time, Asian countries have increased their share of g…
    raps · 8d agoNeutral↗ source
  • Parkinson’s-focused Aspen and bispecific biotech Bambusa plan IPOs
    Parkinson’s disease cell therapy-focused Aspen Neuroscience and bispecific biotech Bambusa Therapeutics are the latest drug developers to eye up a public listing.
    Fierce Biotech · 9d ago↗ source
  • Lilly-backed TRex Bio raises $117M in IPO as hypertension biotech Retension secures $45M listing
    TRex Bio, a biotech backed by Eli Lilly, completed its initial public offering, generating $116.7 million in gross proceeds. The company sold 8.3 million shares at $14 each, landing at the lower en…
    Fierce Biotech · 11d agoDealPositive↗ source
  • GSK partners with Chai Discovery to use AI protein-folding models after successful wet-lab tests
    GSK has entered a collaboration with Chai Discovery, a biotech firm that offers AI‑driven protein folding and design tools. The agreement gives GSK access to Chai's models, which were reported to…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Pfizer signs $500M deal with Enodia to develop Sec61 protein degraders
    Pfizer has entered a licensing and research collaboration with Enodia Therapeutics, valued at up to $500 million, to discover and develop inhibitors of the Sec61 protein‑translocation channel. The…
    Fierce Biotech · 10d agoDealNeutral↗ source
  • Fierce Biotech outlines criteria for its 2026 Fierce 15 list, spotlighting top innovators
    The Fierce Biotech editorial team released its 2026 Fierce 15 list and discussed the selection process on a recent episode of "The Top Line" podcast. More than 150 high‑quality entries were review…
    Fierce Biotech · 10d agoPositive↗ source
  • Nobel-winning optogenetics sees growing biotech interest
    Karl Deisseroth, a Stanford psychiatrist and bioengineer, learned he had shared the 2026 Nobel Prize in Physiology or Medicine for pioneering optogenetics, a method that makes neurons responsive to…
    Fierce Biotech · 10d agoPositive↗ source
  • FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten generics
    The Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
    raps · 11d agoRegulatoryNeutral↗ source
  • Study finds rising patent thickets may slow generic drug competition
    A recent special communication in JAMA reports that the number of patents linked to FDA‑approved small‑molecule drugs has risen over the past 15 years. The increase is driven largely by non‑primary…
    raps · 11d agoNeutral↗ source