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  • 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 · 1mo agoPositive readoutPositive↗ source
  • Bristol Myers revises Phase 3 fibrosis trial after liver safety events, including a death
    Bristol Myers Squibb announced a change to its late-stage Phase 3 "Aloft" trial of the experimental pulmonary fibrosis drug admilparant. The amendment adds closer monitoring for liver-related adve…
    BioPharma Dive · 1mo agoNegative readoutNegative
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Nephrology764
↗ source
  • FDA begins review of Roche’s experimental multiple sclerosis pill fenebrutinib
    The FDA has accepted Roche's application for fenebrutinib, an experimental oral therapy for multiple sclerosis, and has started a priority review. The review will evaluate the drug in both relapsi…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • PhRMA appoints former congressman Eric Cantor as CEO as Pierre Fabre resubmits Ebvallo approval request
    PhRMA announced that former U.S. House member Eric Cantor will become its president and chief executive on Nov 9, taking over from longtime leader Steve Ubl. Cantor served Virginia from 2000 to 201…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • AI chemistry agent gives wrong answer after handling malformed data, highlighting safety concerns in drug research
    An AI chemistry agent called ChemAgent was tasked with checking whether a molecule had a known hepatobiliary side effect. The agent supplied the molecular structure in an invalid format to a speci…
    BioPharma Dive · 1mo agoNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoDealPositive↗ source
  • AstraZeneca puts $2 billion into Summit Therapeutics and partners to test ivonescimab with its oncology pipeline
    AstraZeneca announced a $2 billion equity investment in Summit Therapeutics, acquiring roughly 109,000 shares of convertible preferred stock. The deal will give AstraZeneca about a 12% stake in Sum…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Beam Therapeutics sues YolTech and Serapha Bio over alleged theft of base editing trade secrets
    Beam Therapeutics has filed a lawsuit in U.S. District Court in Massachusetts accusing Chinese biotech YolTech Therapeutics and its U.S. partner Serapha Bio of using confidential information to dev…
    BioPharma Dive · 1mo agoNegative↗ source
  • Novo to pay Hengrui up to $2.6 billion for rights to weekly obesity pill HRS-1596
    Novo announced a deal with China-based Hengrui Pharma, paying $300 million up front for rights to HRS-1596, a once‑weekly obesity pill. The agreement could rise to $2.6 billion if the candidate me…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • ai3Bio raises $48 million to develop T-helper cell-targeted immune-reset therapies
    ai3Bio, a new biotech startup formed from Corner Therapeutics and Novasenta, announced it has secured $48 million in an early-stage venture capital round. The company aims to create treatments for…
    BioPharma Dive · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryPositive↗ source
  • Biopharma layoffs ease in Q3 2026, but cuts still ongoing
    Recruiters note that biopharma layoff volume in Q3 2026 remained modest, suggesting the sector is moving past the large wave of cuts seen last year. Fierce recorded 21 layoff announcements between…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source