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  • Upcoming FDA decisions in Q3 2026 could signal agency flexibility
    The piece highlights five FDA actions slated for the third quarter of 2026 that industry participants are tracking. Observers say the outcomes may reveal how flexible the agency will be under its…
    BioPharma Dive · 20d agoRegulatoryNeutral↗ source
  • House lawmakers hear mixed views on credentialing for psychedelic providers
    As psychedelic medicines move closer to market, two members of the U.S. House are outlining how the drugs might be rolled out and what accompanying legislation could look like. The focus of their…
    Endpoints · 20d agoRegulatoryNeutral↗ source
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  • Merck reports positive mid-stage results for Prometheus' tulisokibart in painful skin disease
    Merck presented new data from a mid-stage trial of tulisokibart, a drug acquired through its $10.8 billion purchase of Prometheus Biosciences. The trial evaluated multiple dose levels in patients…
    Endpoints · 21d agoPositive readoutPositive↗ source
  • Patient death raises safety concerns before Bristol Myers lung drug readout
    A patient died from a fatal liver injury while taking part in a trial of Bristol Myers Squibb's lung disease candidate. The company disclosed the incident in a May amendment to its trial documents…
    Endpoints · 21d agoNegative↗ 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 · 21d agoNegative readoutNegative↗ 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 · 21d agoRegulatoryNeutral↗ source
  • Varda Space Industries secures $251 million Series D to develop drug manufacturing in orbit
    California startup Varda Space Industries announced it has closed a $251 million Series D financing round. The capital will be directed toward building and launching manufacturing facilities in lo…
    Endpoints · 21d agoDealPositive↗ 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 · 21d agoRegulatoryNeutral↗ source
  • Lilly's amylin-Zepbound combo shows up to 23.3% weight loss in obesity-diabetes patients at EASD 2026
    Lilly presented new data on its amylin‑Zepbound combination at the European Association for the Study of Diabetes meeting in Milan. The trial focused on patients who have both obesity and type 2 di…
    Endpoints · 21d agoPositive readoutPositive↗ 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 · 21d agoNegative↗ 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
  • CMS finalizes GLOBE Medicare drug price demo, projected savings cut to $440 million
    The Centers for Medicare & Medicaid Services (CMS) announced it has completed the GLOBE demonstration program, which is intended to lower the cost of prescription drugs covered by Medicare. Earlie…
    Endpoints · 20d agoRegulatoryNeutral↗ source
  • AbbVie’s eczema antibody shows statistically significant benefit in Phase 2 trial
    AbbVie presented Phase 2 results for its experimental eczema treatment, an anti‑IL‑13 antibody named Zumilokibart. The study met its primary endpoints, demonstrating statistically significant impr…
    Endpoints · 21d agoPositive readoutNeutral↗ source
  • American Biotech Innovation Alliance urges Congress to prioritize US leadership in biopharma
    The American Biotech Innovation Alliance, formed in May, appeared on Capitol Hill on September 30, 2026 to address lawmakers. The group argued that maintaining U.S. dominance in biopharma requires…
    Endpoints · 21d agoNeutral↗ source
  • Ned Sharpless joins Hatteras Venture Partners as managing director, Andrew Witty returns as chairman
    Hatteras Venture Partners, a North Carolina venture capital firm focused on life‑science startups, announced that former National Cancer Institute director Norman “Ned” Sharpless has joined the fir…
    Endpoints · 21d agoDealPositive↗ 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
  • 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
  • Lilly's triple-agonist retatrutide drives up to 18.8% weight loss, over half of patients fall below obesity threshold
    At the EASD Annual Meeting in Milan, Eli Lilly presented data on its triple‑agonist retatrutide. The trial involved participants with obesity and type 2 diabetes and showed weight reductions of up…
    Endpoints · 21d agoPositive readoutPositive↗ 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 · 22d agoDealNeutral↗ source
  • Zealand and Roche's amylin analog shows modest weight loss at middle dose, lagging behind Lilly's in Phase 2 trial
    Zealand and Roche reported new data from their Phase 2 obesity trial of an amylin analog at a recent conference. The earlier topline results in March had been viewed as disappointing. The updated…
    Endpoints · 21d agoNegative readoutNegative↗ source
  • Beam Therapeutics sues Chinese scientists and firms YolTech, Serapha Bio over alleged gene-editing technology theft
    Beam Therapeutics, a Cambridge-based company developing CRISPR base editing therapies, has filed a lawsuit. The suit names two Chinese scientists and the biotech firms YolTech and Serapha Bio, acc…
    Endpoints · 21d agoNegative↗ 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 · 22d agoNegative↗ source
  • PhRMA appoints former House Majority Leader Eric Cantor as new president and CEO
    Former House Majority Leader Eric Cantor has been selected to lead PhRMA, the industry trade group representing pharmaceutical companies. The announcement was made on Tuesday, following earlier re…
    Endpoints · 22d agoNeutral↗ 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 · 22d agoDealNeutral↗ source
  • Ascletis pursues oral IL-17A inhibitor for psoriasis as Invivyd readies COVID-19 filing
    Ascletis, a biotech listed in Hong Kong, is developing a small‑molecule IL-17A inhibitor in pill form to treat psoriasis. The company aims to challenge the current injectable therapies that target…
    Endpoints · 22d agoRegulatoryNeutral↗ source