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992 stories matching this filter · ← front page

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  • 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 · 20d 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 · 20d agoRegulatoryNeutral↗ source
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  • BMS trial sees patient death, analysts say drug mechanism still viable
    Bristol Myers Squibb is running a phase 3 study of an LPA1 inhibitor, admilparant, for idiopathic and progressive pulmonary fibrosis. A patient death was reported after the trial was amended to inc…
    Fierce Biotech · 20d agoNeutral↗ source
  • ICMRA urges cut to animal testing while HHS launches ARPA-H SURPASS program to accelerate clinical trials
    International Coalition of Medicines Regulatory Authorities released a joint statement urging drug makers and national control labs to cut back on animal testing throughout a medicine’s development…
    raps · 20d agoRegulatoryNeutral↗ source
  • HHS unveils ARPA-H SURPASS program to accelerate clinical trial design
    The U.S. Department of Health and Human Services announced a new initiative under ARPA-H called the Simulation‑augmented, Real‑time Platform Adaptive Seamless Trials (SURPASS) program. SURPASS is…
    raps · 20d agoRegulatoryPositive↗ source
  • Bayer names Christoph Koenen as new chief medical officer as Eric Cantor becomes PhRMA CEO
    Bayer announced that Christoph Koenen, M.D., has been appointed as its new chief medical officer. Koenen, who joined Bayer in 2022 after roles at Bristol Myers Squibb, Novo, Boehringer and GSK, wil…
    Fierce Biotech · 20d agoNeutral↗ source
  • Lilly's amylin-Zepbound combo shows 23% weight loss in type 2 diabetes patients
    Eli Lilly reported that its amylin‑Zepbound combination, eloraTZP, produced an average 23.3% weight loss in adults with type 2 diabetes who were also obese or overweight. The result was derived fro…
    Fierce Biotech · 21d agoPositive readoutPositive↗ source
  • Eli Lilly's retatrutide shows over a third of patients lose 25%+ weight in phase 3 trial
    Eli Lilly presented detailed results from its phase 3 retatrutide trial at the European Association for the Study of Diabetes meeting in Milan and in a recent Lancet publication. The study enrolle…
    Fierce Biotech · 21d agoPositive readoutPositive↗ source
  • GSK pays $12 million to Wave for liver-focused siRNA program, expanding its RNA drug pipeline
    GSK is paying Wave Life Sciences $12 million upfront to take ownership of a hepatic program that emerged from their long‑running collaboration. The payment follows a 2022 agreement in which GSK pa…
    Fierce Biotech · 21d agoDealPositive↗ source
  • Mid-dose petrelintide shows strongest weight loss in phase-2 trial, paving way for pivotal study
    Roche and Zealand Pharma released new phase-2 data for petrelintide, an amylin analog being developed for obesity treatment. In the Zupreme 1 trial, the 5 mg dose achieved the greatest mean weight…
    Fierce Biotech · 21d agoPositive readoutPositive↗ source
  • Beam Therapeutics sues rival YolTech over alleged theft of base-editing data for AATD therapy
    Beam Therapeutics, a base editing biotech, filed a lawsuit in U.S. District Court in Massachusetts against YolTech Therapeutics and former employee Zi Jun (Emma) Wang, alleging theft of proprietary…
    Fierce Biotech · 21d agoNegative↗ source
  • Amgen's daxdilimab shows 6-point CLASI-A reduction in phase 2 lupus trial
    Amgen reported data from its phase 2 study of the ILT7-targeting monoclonal antibody daxdilimab in patients with discoid lupus. The trial enrolled 72 patients and tested two dose levels. The lower…
    Fierce Biotech · 21d agoPositive readoutPositive↗ source
  • FDA seeks new advisory committee members, signaling renewed focus on external expertise
    The FDA announced it is inviting subject‑matter experts and consumer representatives to serve on its advisory committees. The call follows a period when the advisory committees had a reduced role…
    raps · 21d agoRegulatoryNeutral↗ source
  • Merck reports positive phase 2b results for anti-TL1A antibody in hidradenitis suppurativa
    Merck announced that its experimental anti-TL1A antibody achieved a positive outcome in a phase 2b study. The trial enrolled patients with moderate to severe hidradenitis suppurativa, a chronic in…
    Fierce Biotech · 21d agoPositive readoutPositive↗ source
  • Connect Biopharma's IL-4/IL-13 blocker cuts COPD exacerbations by 85% in Phase 2 trial
    Connect Biopharma reported phase 2 results for its IL-4/IL-13 inhibitor rademikibart in COPD patients. In the Seabreeze STAT study of 159 participants who had recent exacerbations, adding rademiki…
    Fierce Biotech · 21d agoPositive readoutNeutral↗ source
  • VertigoDx receives FDA 510(k) clearance for its portable SmartVertigo diagnostic system
    The U.S. Food and Drug Administration has issued a 510(k) clearance for VertigoDx's portable vertigo assessment tool, allowing it to be marketed in the United States. The system, called SmartVerti…
    Fierce Biotech · 21d agoRegulatoryPositive↗ source
  • Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rules
    Industry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…
    raps · 21d agoRegulatoryNeutral↗ source
  • AstraZeneca invests $2 billion in Summit Therapeutics to advance PD-1xVEGF bispecific ivonescimab with ADC combos
    AstraZeneca is committing $2 billion to Summit Therapeutics, acquiring a 12% equity stake at a premium to the biotech's closing price. The funding is aimed at accelerating development of the PD‑1xV…
    Fierce Biotech · 22d agoDealPositive↗ source
  • FDA approves Egetis’ Emcitate for rare genetic disease as Novo secures Chinese weight-loss pill in $2.6 billion deal
    The U.S. Food and Drug Administration has granted approval to Egetis' Emcitate, a therapy targeting a rare genetic disorder. This marks a regulatory milestone for the company and patients awaiting…
    raps · 22d agoDealPositive↗ source
  • Novo Nordisk signs $2.6 billion deal with China's Hengrui for oral GLP-1/GIP candidate
    Novo Nordisk announced a licensing agreement with Chinese drugmaker Hengrui Pharmaceuticals, paying $300 million upfront for rights to a preclinical GLP-1/GIP dual-receptor agonist. The candidate,…
    Fierce Biotech · 22d agoDealPositive↗ source
  • Highlight Therapeutics reports positive Phase 2b results for BO-112 in high‑risk head and neck basal cell carcinoma
    Highlight Therapeutics announced that its Phase 2b study of BO-112 met the primary endpoint of visual and pathological response at week 24 in patients with localized high‑risk head and neck basal c…
    Fierce Biotech · 22d agoPositive readoutPositive↗ source
  • uniQure shares tumble 41% after Huntington’s gene therapy misses primary endpoint
    uniQure reported updated 48‑month data from its phase 1/2 trial of AMT‑130 in Huntington’s disease. The therapy showed a 44% slowing of disease progression on the composite Unified Huntington’s Dis…
    Fierce Biotech · 22d agoNegative readoutNegative↗ source
  • Regulators Discuss Plans to Streamline Europe’s Drug Approval Process at 2026 RAPS Convergence
    A panel of European regulators gathered at the 2026 RAPS Convergence in Charlotte, North Carolina to discuss ongoing initiatives aimed at simplifying the continent’s regulatory framework. The offi…
    raps · 22d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on requirements for robotically assisted surgical devices
    The FDA has published a draft guidance outlining its thinking on the requirements for bringing certain robotically assisted surgical devices to market. The guidance describes both non-clinical and…
    raps · 22d agoRegulatoryNeutral↗ source
  • Ontario launches $5M QuickStart program to cut clinical trial start-up time to 45 days
    Ontario’s Clinical Trials Ontario has introduced a $5 million QuickStart program that promises to reduce the time needed to launch a clinical trial to as little as 45 days. The initiative is desig…
    Fierce Biotech · 22d agoRegulatoryPositive↗ source