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  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 14d agoRegulatoryNeutral↗ source
  • Roche's KRAS G12C inhibitor cuts death risk by 44% versus Amgen and BMS in lung cancer trial
    At the European Society for Medical Oncology meeting in Madrid, Roche presented data on its next‑generation KRAS G12C inhibitor in non‑small cell lung cancer. In a head‑to‑head study against compa…
    Endpoints · 15d agoPositive readoutPositive↗ source
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  • Akeso reports survival benefit for ivonescimab in China-only biliary tract cancer trial, likening results to Keytruda
    Akeso announced new data from a late‑stage study of its PD‑1×VEGF bispecific antibody ivonescimab in patients with biliary tract cancer enrolled only in China. The trial showed an improvement in o…
    Endpoints · 14d agoPositive readoutPositive↗ source
  • Pfizer shifts focus after lung cancer trial setback, cites early signals in earlier-line patients; BioNTech and BMS report initial activity
    Pfizer’s late‑stage trial in non‑small cell lung cancer did not meet its primary endpoint, prompting the company to highlight a post‑hoc analysis that suggests benefit for patients treated earlier…
    Endpoints · 15d agoNeutral↗ source
  • AstraZeneca reports Tagrisso-Orpathys combo could prolong treatment for EGFR-mutant lung cancer
    At the European Society for Medical Oncology meeting, AstraZeneca said early data suggest that adding Orpathys to Tagrisso may let patients with mutant non‑small cell lung cancer continue therapy a…
    Endpoints · 15d agoPositive readoutPositive↗ source
  • #ESMO26: Merck and Moderna's cancer vaccine data were 'a triumph of science.' And now, the work begins
    MADRID — In a testament to clinicians’ interest in Merck and Moderna’s personalized cancer vaccine data at this year’s European Society for Medical Oncology conference, the presidential symposium,…
    Endpoints · 15d ago↗ source
  • Amgen's Imdelltra plus AstraZeneca's Imfinzi cuts death risk by 58% in small cell lung cancer Phase 3 trial
    Amgen reported results from a Phase 3 trial evaluating its investigational therapy Imdelltra in combination with AstraZeneca’s immunotherapy Imfinzi in patients with small cell lung cancer. The st…
    Endpoints · 16d agoPositive readoutPositive↗ source
  • Merck and Moderna present Phase 3 cancer vaccine data at ESMO26 amid Treasury proposal on China investment
    Endpoints Weekly reporter Nicole DeFeudis writes from Madrid during the ESMO26 meeting. The most anticipated presentation was a Phase 3 study of a cancer vaccine jointly developed by Merck and Mod…
    Endpoints · 16d agoNeutral↗ source
  • AstraZeneca, Lilly and Bayer unveil new strategies at ESMO 2026 in Madrid
    At the European Society for Medical Oncology (ESMO) congress in Madrid, nearly 40,000 delegates gathered for the five-day meeting. AstraZeneca said it is evaluating the use of its immunotherapy Ke…
    Endpoints · 16d agoNeutral↗ source
  • US Treasury proposes rule that could bar biotech investments in China
    The Treasury Department issued a proposed rule to implement the 2025 COINS Act, which governs U.S. investment in sensitive technologies in China and other countries. The proposal places a broad ra…
    Endpoints · 17d agoRegulatoryNegative↗ source
  • Lycia Therapeutics raises $317.5 million in IPO as Merck halts sac-TMT trial
    Lycia Therapeutics, founded by Nobel laureate Carolyn Bertozzi, priced its initial public offering at about $317.5 million, bringing total proceeds to roughly $318 million. The offering marks the…
    Endpoints · 17d agoDealNeutral↗ source
  • Pathos AI secures $237M Series E funding at $3B valuation, partners with Bristol Myers on neuroscience
    Pathos AI, an AI-focused biotech based in New York, announced it has closed a Series E financing round raising $237 million. The round values the company at $3 billion, reflecting investor confide…
    Endpoints · 17d agoDealPositive↗ source
  • Warp Sciences raises $215 million Series A to apply AI in drug building-block design
    Former OpenAI head of science Kevin Weil announced the launch of Warp Sciences, a new startup aimed at accelerating the creation of molecular building blocks for drug discovery. The company secure…
    Endpoints · 17d agoDealPositive↗ source
  • Gilead agrees to pay $1.28 billion upfront to China's PepStar for oral IL-23 inflammation drug candidate
    Gilead Sciences announced a deal with Chinese biotech PepStar Therapeutics to acquire an early-stage oral IL-23 inhibitor. The agreement includes an upfront payment of roughly $1.28 billion for Pe…
    Endpoints · 17d agoDealNeutral↗ source
  • Roche signs up to $813M deal with Zymeworks for preclinical trispecific T cell engager
    Roche announced a partnership with Zymeworks that includes an upfront payment of $55 million for worldwide rights to a trispecific T cell engager currently in preclinical development. The agreemen…
    Endpoints · 17d agoDealPositive↗ source
  • Bristol Myers reports patient death in autoimmune CAR-T trial and explains summer pause
    Bristol Myers Squibb disclosed that a participant in its autoimmune CAR-T cell therapy study has died. The company said the death occurred during the trial and is under investigation, with details…
    Endpoints · 17d agoNegative↗ source
  • Star Therapeutics raises $200 million to build new drug pipeline after Vega and Electra wins
    Star Therapeutics announced it has secured $200 million in financing. The capital will be used to develop its own pipeline of medicines, aiming to replicate the success of its earlier Vega and Ele…
    Endpoints · 17d agoDealPositive↗ source
  • Alnylam to launch larger study of RNA therapy for Huntington’s disease
    Alnylam Therapeutics announced it will expand its clinical program for an RNA‑based drug aimed at treating Huntington’s disease. The decision comes amid a challenging landscape for neurodegenerati…
    Endpoints · 17d agoNeutral↗ source
  • Bristol Myers Squibb identifies cause of safety signal in lupus CAR‑T trial
    Bristol Myers Squibb's cell therapy division is confronting ongoing safety challenges with its autoimmune CAR‑T program. The company says it has pinpointed the underlying cause of the safety signa…
    Endpoints · 17d agoRegulatoryNeutral↗ source
  • Biotech M&A slows sharply in Q3 as deal activity cools
    The third quarter saw a noticeable slowdown in biotech mergers and acquisitions after a busy first half of the year. Large upfront licensing agreements were fewer, and venture capital firms reduce…
    Endpoints · 17d agoDealNegative↗ source
  • Swiss biotech Windward Bio files for Nasdaq IPO to raise funds for China-derived assets and R&D
    Windward Bio, a Basel-based European biotech founded two years ago, announced it has filed its registration statements to list on Nasdaq. The company plans to use the proceeds to support two clini…
    Endpoints · 16d agoDealPositive↗ source
  • Tango combo clears Rasonque bar and Takeda's Innovent sees early returns as ESMO data leaks dampen hype
    The first day of the European Society for Medical Oncology (ESMO) congress opened in Madrid with several notable updates from the oncology field. Tango's combination therapy cleared the Rasonque r…
    Endpoints · 17d agoRegulatoryNeutral↗ source
  • Voyager Therapeutics CEO Al Sandrock to resign next year, remains on board; Insmed appoints Paul Hudson as director
    Voyager Therapeutics announced that its chief executive, Al Sandrock, will step down in the first quarter of next year. Sandrock will continue to serve on Voyager's board after his resignation, pr…
    Endpoints · 17d agoNeutral↗ source
  • Drug safety group petitions FDA to block marketing of unapproved compounded peptides; bipartisan bill seeks clinical trial reforms
    A drug safety advocacy group has filed a citizen petition with the FDA, asking the agency to stop the marketing of compounded peptide products that lack approval. A bipartisan group of lawmakers h…
    raps · 17d agoRegulatoryNeutral↗ source
  • Experts urge cultural shift and standards to unlock real-world evidence potential in medtech
    At The MedTech Conference in Boston, experts highlighted the need for a cultural shift to build trust between regulators and medtech firms when using real-world evidence (RWE) for device marketing.…
    raps · 17d agoNeutral↗ source