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  • GSK says UK restructuring will have limited impact on staff, focusing cuts on support roles
    GSK executives said the company's global restructuring will only modestly affect UK staff, mainly targeting support functions at headquarters. CEO Luke Miels explained during the Q3 earnings call…
    Fierce Biotech · 16d agoLayoffsNegative↗ source
  • FDA issues draft guidance for electronic IDE submissions via eSTAR
    The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
    raps · 16d agoRegulatoryNeutral↗ source
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  • Lilly’s ‘triple-G’ drug tops Novo’s Ozempic in diabetes trial
    The highest dose of retatrutide beat Ozempic on measures of blood sugar and weight loss, but was also associated with higher side effect rates and treatment discontinuations.
    BioPharma Dive · 16d ago↗ source
  • Novartis CEO keeps faith in Avidity deal despite taking $1.9B hit from del-desiran fail
    Novartis CEO Vas Narasimhan has insisted that the phase 3 fail for del-desiran is just a “bump” in the Swiss pharma’s wider plans for the drug, despite costing the company an estimated $1.9 billion.
    Fierce Biotech · 17d agoNegative readoutNegative↗ source
  • GSK's B7-H3 ADC cuts osteosarcoma progression risk by 67% in Chinese phase 3 trial
    A phase 3 study in China evaluated GSK's B7-H3‑directed antibody‑drug conjugate, risvutatug rezetecan (ris‑rez), in patients with relapsed osteosarcoma. The trial met its primary endpoint, showing…
    Fierce Biotech · 17d agoPositive readoutPositive↗ source
  • Syntax Bio claims four-day stem-cell conversion into pancreatic beta cells
    Chicago-based Syntax Bio says its Cellgorithm platform can turn stem cells into pancreatic beta cells in as little as four days. The company describes the process as a programmable set of epigeneti…
    Fierce Biotech · 17d agoPositive readoutPositive↗ source
  • Artiva Biotherapeutics cuts 94% of workforce after patient deaths and failed autoimmune cell therapy
    Artiva Biotherapeutics announced it is halting development of its AlloNK natural killer cell therapy for autoimmune diseases and is laying off roughly 94% of its employees. The AlloNK product, an…
    Fierce Biotech · 17d agoLayoffsNegative↗ source
  • Labcorp acquires Millennium Health to expand toxicology testing nationwide
    Labcorp announced it is buying Millennium Health, a specialty laboratory that provides toxicology tests for recent use of prescription medications and illicit drugs. The acquisition is intended to…
    Fierce Biotech · 17d agoDealPositive↗ source
  • FDA releases draft guidance on oversight of individualized gene-editing products
    The U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…
    raps · 17d agoRegulatoryNeutral↗ source
  • Federal judge denies Novo's attempt to block Eli Lilly obesity drug ads
    A federal judge in the U.S. District Court denied Novo Nordisk's request to halt an Eli Lilly advertising campaign that compared the two companies' obesity treatments, Wegovy and Zepbound. Novo ar…
    BioPharma Dive · 17d agoRegulatoryNeutral↗ source
  • Aspen Neuroscience and Bambusa Therapeutics each target $134 million IPOs
    Aspen Neuroscience, a cell‑therapy company focused on Parkinson's disease, and Bambusa Therapeutics, a bispecific biotech, have filed SEC documents outlining plans for initial public offerings. Bo…
    Fierce Biotech · 17d agoDealNeutral↗ source
  • Leak of Moderna-Merck cancer vaccine phase 3 data sparks drama at ESMO 2026 conference
    The European Society for Medical Oncology (ESMO) meeting this year was marked by an unexpected leak of phase 3 results for a cancer vaccine being developed by Moderna and Merck. The data appeared t…
    Fierce Biotech · 17d agoNeutral↗ source
  • FDA approves prostate cancer and Crohn’s disease therapies as judge rejects effort to block Lilly weight‑loss ads
    The U.S. Food and Drug Administration announced approvals for new treatments targeting prostate cancer and Crohn’s disease. The decisions expand therapeutic options for patients with these conditio…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech Conference
    At the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…
    raps · 17d agoRegulatoryNeutral↗ source
  • Ferring to acquire next-gen IVF startup Gameto for up to $1.4B
    The buyout hands Ferring rights to a technology capable of simplifying the lengthy and burdensome process of in vitro fertilization.
    BioPharma Dive · 17d ago↗ source
  • Artiva to quit autoimmune cell therapy work, cut staff after patient deaths
    The disclosure makes Artiva the third company to recently report fatal events in an autoimmune cell therapy trial, following announcements from Novartis and Bristol Myers Squibb.
    BioPharma Dive · 17d ago↗ source
  • Melanoma vaccine shows 42% risk reduction at ESMO 2026, but shares tumble on early data release
    Moderna and Merck presented Phase 3 results for their melanoma vaccine intismeran autogene at the European Society for Medical Oncology meeting. The trial reported a 42% reduction in the relative r…
    BioPharma Dive · 18d agoPositive readoutNeutral↗ source
  • Boehringer Ingelheim and Microsoft launch AI partnership to develop digital patient twins for clinical trials
    Boehringer Ingelheim and Microsoft announced a collaboration to investigate AI driven digital patient twins that model individual patients for clinical trial design. The work will explore disease…
    Fierce Biotech · 18d agoDealPositive↗ source
  • Anthropic IPO filing reveals plans to build a drug discovery lab and pursue AI-driven therapeutics, noting scientific and regulatory hurdles
    Anthropic, known for its Claude AI platform, disclosed in its S-1 that it intends to expand into life-science research, including establishing its own molecular biology laboratory. The company aim…
    Fierce Biotech · 18d agoNeutral↗ source
  • Tango Therapeutics reports 82% response rate for PRMT5 inhibitor combo in pancreatic cancer trial
    Tango Therapeutics announced a 14% reduction in its workforce while also presenting new data on its PRMT5 inhibitor combined with Revolution Medicines’ RAS(ON) inhibitor Rasonque at the ESMO 2026 m…
    Fierce Biotech · 18d agoPositive readoutPositive↗ source
  • Corxel to go public via $300 million SPAC merger, advancing GLP-1 pill CX11 and amylin candidate
    Corxel Pharmaceuticals announced it will become a public company by merging with the SPAC Amanat Acquisition Corp., accompanied by a $300 million private investment. The transaction will fund the…
    BioPharma Dive · 18d agoDealPositive↗ source
  • Patient dies after receiving Bristol Myers experimental autoimmune CAR-T therapy zola-cel
    A participant in Bristol Myers Squibb’s multiple sclerosis trial died 44 days after being infused with the experimental cell therapy known as zola-cel. The company disclosed that the patient develo…
    BioPharma Dive · 18d agoNegative readoutNegative↗ source
  • Bristol Myers Squibb partners with Institute for Healthcare Improvement to increase cancer trial participation
    Bristol Myers Squibb has entered a three-year collaboration with the Institute for Healthcare Improvement called the Cancer Collective Action Collaborative. The program will bring together 24 team…
    Fierce Biotech · 18d agoPositive↗ source
  • Overlooked drugs can gain value when markets evolve, says Azurity CEO
    Ron Scarboro, chief executive of Azurity Pharmaceuticals, wrote about how medicines that seemed unsuccessful can become valuable when market conditions change. He argues that the industry often co…
    BioPharma Dive · 18d agoNeutral↗ source
  • BioNTech's HER2-directed ADC shows modest benefit and higher lung toxicity in phase 3 trial
    BioNTech reported results of its phase 3 DYNASTY-Breast02 trial evaluating trastuzumab pamirtecan (t-pam), an HER2-directed antibody-drug conjugate, in patients with HR-positive, HER2-low metastati…
    Fierce Biotech · 18d agoNegative readoutNegative↗ source