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  • Atara and Pierre Fabre resubmit Ebvallo cell therapy after second FDA rejection
    Atara Biotherapeutics and Pierre Fabre Pharmaceuticals have filed a new FDA submission for their cell therapy candidate Ebvallo (tabelecleucel), aimed at treating Epstein‑Barr virus‑positive post‑t…
    BioSpace · 20d 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 · 20d agoRegulatoryNeutral↗ source
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  • 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 · 20d agoPositive readoutPositive↗ source
  • Lilly uses indirect data to argue its oral GLP-1 pill may outperform Novo’s semaglutide
    Eli Lilly’s weight‑loss drug Foundayo has seen a slower launch than expected, according to BMO Capital Markets, which noted the product is lagging behind competitors. To bolster its market case, L…
    BioSpace · 20d agoPositive readoutNeutral↗ 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 · 20d agoNegative↗ source
  • AstraZeneca invests $2 billion in Summit Therapeutics as uniQure shares tumble on disappointing Huntington’s data
    Summit Therapeutics received a $2 billion all‑stock investment from AstraZeneca aimed at advancing its bispecific antibody ivonescimab through late‑stage trials. The funding is expected to support…
    BioSpace · 21d agoDealNeutral↗ 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 · 20d agoPositive readoutNeutral↗ source
  • Massachusetts offers $40M in tax incentives to spur 1,600+ life-science jobs
    Massachusetts announced $40 million in tax incentives for 38 life‑science companies, targeting the creation of about 1,644 new jobs. Most of the companies-31 of them-will expand outside Boston and…
    BioSpace · 20d agoRegulatoryPositive↗ source
  • BioNTech to shut three German manufacturing sites after failing to secure buyers, risking 1,860 jobs
    BioNTech announced it will close three manufacturing facilities in Germany after an unsuccessful search for buyers. The sites in Idar-Oberstein, Marburg and Tübingen were slated for possible sale,…
    BioSpace · 20d agoNegative↗ 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 · 20d 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
  • Bicara CEO Claire Mazumdar to step down, COO Ryan Cohlhepp to assume leadership in 2027
    Claire Mazumdar, who co‑founded Bicara and has served as its chief executive for almost seven years, announced she will step down at the end of the year. She will take parental leave and then move…
    BioSpace · 21d agoPositive↗ 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
  • Women-led biotech M&A drops sharply in 2026, only two major deals recorded so far
    Last year saw an unprecedented wave of women-led biotech transactions, with eleven high‑value deals out of 72 total biopharma mergers in 2025. In 2026 the pace has slowed dramatically, with just…
    BioSpace · 21d agoDealNegative↗ source
  • Biopharma must incentivize scientists to make early go-no-go decisions
    The article argues that simply urging scientists to think like entrepreneurs is not enough; biopharma firms need to align rewards with that mindset. Because only about one in ten drug candidates t…
    BioSpace · 21d agoNeutral↗ source
  • Biopharma needs to reward scientists' judgment
    It’s not enough for organizations to want scientists to think like entrepreneurs. They have to incentivize and reward for that behavior.
    BioSpace · 21d ago↗ 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
  • AstraZeneca invests $2 billion in Summit Therapeutics to fund Phase 3 trials of ivonescimab
    AstraZeneca has agreed to a $2 billion all‑stock investment in Summit Therapeutics. The deal involves the purchase of preferred shares that can be converted into common stock, but it does not inclu…
    BioSpace · 21d 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 · 21d agoDealNeutral↗ source
  • Curium gains FDA nod for Bexlutry as it eyes challenge to Novartis radioligand therapies
    Curium recently received FDA approval for its radiopharmaceutical Bexlutry, positioning it as a direct competitor to Novartis’ Lutathera. The biotech is also in discussions with the FDA about fili…
    BioSpace · 22d agoApprovalNeutral↗ 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