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  • 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 · 1mo 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 · 1mo agoDealPositive↗ source
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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
  • 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 · 1mo agoRegulatoryNeutral↗ source
  • FDA launches nationwide recruitment to broaden scientific and consumer representation on advisory committees
    The U.S. Food and Drug Administration announced a new nationwide effort to recruit qualified experts and consumer representatives for its advisory committees. The agency issued two Federal Register…
    fda press · 1mo agoRegulatoryPositive↗ 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 · 1mo agoPositive readoutNeutral↗ 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
  • 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 · 1mo agoDealNeutral↗ 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
  • 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 · 1mo 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 · 1mo agoNegative↗ 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
  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo ago↗ 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
  • 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 · 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
  • 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 · 1mo agoApprovalNeutral↗ source