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912 stories matching this filter · ← front page

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  • H1 partners with Novo Nordisk to build AI-driven data foundation for clinical development
    Clinical trials are becoming more complex and data‑heavy, but decision‑making processes have not kept pace. H1 and Novo Nordisk are collaborating to address this gap. Novo Nordisk’s StudyHub links…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Fortrea acquires Worldwide Clinical Trials' early-phase division for $45 million
    Fortrea announced it will purchase the early-phase services division of Worldwide Clinical Trials for $45 million. The transaction gives Fortrea control of Worldwide's clinical pharmacology unit,…
    Fierce Biotech · 9d agoDealPositive↗ source
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Infectious Disease456
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 9d agoPositive readoutPositive↗ source
  • Novartis to cut about 130 jobs in Switzerland as it reshapes biologics production in Basel
    Novartis announced it will eliminate roughly 130 positions in Switzerland as part of a reorganization of its biologics technical development and manufacturing footprint in Basel. The company plans…
    Fierce Biotech · 9d agoLayoffsNegative↗ source
  • Teva's anti-IL-15 antibody meets primary endpoint in phase 2a celiac disease trial
    Teva Pharmaceuticals reported that its anti‑interleukin‑15 antibody, TEV‑408, achieved the primary endpoint in a phase 2a study of 50 adults with celiac disease. Participants received a single dose…
    Fierce Biotech · 9d agoPositive readoutPositive↗ source
  • SEC and FDA sign three-year info-sharing pact to boost market integrity and public-health oversight
    The U.S. Securities and Exchange Commission and the Food and Drug Administration have entered into a three-year memorandum of understanding to expand cooperation and share information. The MOU is…
    Fierce Biotech · 9d agoRegulatoryPositive↗ source
  • TScan Therapeutics cuts 75% of staff to focus on preclinical solid tumor programs
    TScan Therapeutics said it will cut about three quarters of its workforce after pausing its hematological and autoimmune programs. The company will shift resources to its preclinical solid tumor p…
    Fierce Biotech · 9d agoLayoffsNegative↗ source
  • EMA starts voluntary data-sharing pilot to boost confidence in new approach methods and cut animal testing
    The European Medicines Agency announced a voluntary data submission pilot that allows drug developers to upload data generated by new approach methodologies (NAMs). The pilot is designed to build…
    raps · 10d agoRegulatoryPositive↗ source
  • FDA alerts AVID Medical users to correct convenience kits containing recalled sodium chloride ampules
    The Center for Devices and Radiological Health has posted an Early Alert warning that certain AVID Medical convenience kits may contain sodium chloride ampules recalled by Huons Co. AVID Medical h…
    fda medwatch · 10d agoRegulatoryNeutral↗ source
  • Medline issues correction for convenience kits with potentially non-sterile BD ChloraPrep applicators
    Medline has sent a correction notice after the FDA identified that some BD ChloraPrep applicators included in its convenience kits may not be sterile. The agency says the devices could cause tempo…
    fda medwatch · 10d agoCRLNeutral↗ source
  • Frutas y Hortalizas del Sur expands recall to include Great Value organic triple berry blend over possible E. coli O145 contamination
    On September 2, 2026, Frutas y Hortalizas del Sur S.A. announced that it is expanding the recall it issued on July 3, 2026 for frozen organic IQF blueberries. The expansion adds one lot of Great V…
    fda recalls · 9d agoCRLNegative↗ source
  • Moderna and Merck's mRNA cancer vaccine extends survival in phase 3 melanoma trial
    Merck and Moderna reported that their personalized mRNA cancer vaccine improved patient outcomes in a late-stage study. The phase 3 INTerpath-001 trial enrolled 1,137 patients who had surgery to r…
    Fierce Biotech · 10d agoPositive readoutPositive↗ source
  • Alumis' TYK2 inhibitor flunks mid-stage lupus trial, shares drop 55%
    Alumis reported that its experimental TYK2 inhibitor, envudeucitinib, failed to meet any primary or secondary endpoints in a mid-stage study of systemic lupus erythematosus. The company highlighte…
    BioPharma Dive · 10d agoNegative readoutNegative↗ source
  • Novartis reports Phase 3 success for MS pill remibrutinib, beats Aubagio and shows no liver safety issues
    Novartis announced that its BTK inhibitor remibrutinib met primary endpoints in two Phase 3 trials in patients with relapsing multiple sclerosis. The studies showed the drug reduced annualized rel…
    BioPharma Dive · 10d agoPositive readoutPositive↗ source
  • Roche signs $1.53 billion licensing deal with Simcere for preclinical B-cell antibody
    Roche announced a licensing agreement with China's Simcere Zaiming, paying $75 million upfront and potentially up to $1.53 billion in total, for worldwide rights to a preclinical trispecific antibo…
    Fierce Biotech · 11d agoDealPositive↗ source
  • GSK's mRNA flu vaccine shows stronger immune response than standard shots in phase 2, prompting phase 3 launch
    GSK reported that its experimental mRNA seasonal influenza vaccine generated higher immune responses than both standard and high-dose flu shots in a phase-2 study involving nearly 1,000 adults. Th…
    Fierce Biotech · 11d agoPositive readoutPositive↗ source
  • Medtronic recalls Bravo CF reflux monitoring capsule after 184 serious injuries reported
    Medtronic has issued a recall of its Bravo CF esophageal pH monitoring capsule, a wireless device used to assess acid reflux. The recall follows an FDA early alert after the company identified a pr…
    Fierce Biotech · 11d agoCRLNegative↗ source
  • Boston Scientific stops sales of Imager II catheters after tip defect linked to two injuries
    Boston Scientific issued a letter on August 24 advising customers to remove all Imager II angiographic catheters from use or sale after discovering a manufacturing problem. The problem involves re…
    Fierce Biotech · 11d agoCRLNegative↗ source
  • Arsenal Biosciences cuts 99 jobs as it pivots to in-vivo CAR-T therapy
    Arsenal Biosciences announced a major restructuring, laying off 99 employees, which represents the majority of its workforce across all teams and locations. The company is ending development of it…
    Fierce Biotech · 11d agoLayoffsNegative↗ source
  • Alumis' lupus trial misses endpoints, but company eyes phase 3 in IFNGS‑high subgroup
    Alumis reported that its phase 2b study of the TYK2 inhibitor envudeucitinib failed to meet both the primary and secondary efficacy endpoints in patients with moderate to severe systemic lupus eryt…
    Fierce Biotech · 11d agoNegative readoutNegative↗ source
  • Novocure cyberattack exposes data of over 1,400 U.S. patients and staff
    Novocure disclosed a cyberattack in an SEC filing, saying unauthorized access to some information systems was discovered in mid‑August. The breach exposed internal patient ID numbers for more than…
    Fierce Biotech · 11d agoNegative↗ source
  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 11d agoRegulatoryNeutral↗ source
  • FDA urges validation of digital health endpoints and clear missing-data plans
    FDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…
    raps · 11d agoRegulatoryNeutral↗ source
  • Trump unveils pricing agreements with midsize biotech firms; Novartis halts CAR-T trial after patient deaths
    The White House announced that President Trump has struck new pricing agreements with a group of midsize biotechnology companies, aiming to adjust drug costs. Novartis disclosed that it is pausing…
    raps · 11d agoDealNeutral↗ source
  • Absci CEO envisions AI-driven, consumer-focused drug platform, eyeing hair loss, endometriosis and future GLP-1 combos
    Absci, an AI‑focused biotech founded about 15 years ago in Vancouver, Washington, is led by CEO Sean McClain, who likens his ambition for the company to creating the Apple of biotech. The surge in…
    Fierce Biotech · 10d agoPositive↗ source