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  • FDA advisory panel unanimously backs Moderna’s flu vaccine
    The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend Moderna’s seasonal influenza vaccine. The vote overturns earlier hesitations from previous agen…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • U.S. Treasury Considers New Screening Rules for Investments in Chinese Biotech
    Treasury Department officials are reviewing possible measures to screen U.S. capital flowing into Chinese biotechnology firms, according to multiple sources familiar with the discussions. The revi…
    Endpoints · 2mo agoRegulatoryNegative↗ source
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  • Biogen to acquire RayThera in up to $1 billion deal for immunology pipeline
    Biogen announced it will acquire RayThera, a startup founded in 2023, in a deal valued at up to $1 billion. The acquisition gives Biogen access to RayThera’s immunology pipeline, which includes th…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Pfizer CFO Dave Denton to leave; Denali Therapeutics sells $195 million FDA priority review voucher
    Pfizer announced that its chief financial officer Dave Denton will depart on Aug. 15 to take a role outside the pharmaceutical sector. He has been CFO since May 2022. In the interim, finance chief…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • Pfizer CFO to leave in August as GSK secures approval for urinary-tract infection drug
    Pfizer announced that its chief financial officer, Dave Denton, will step down in August, ending his tenure at the company. GSK reported that it has received regulatory approval for a new treatmen…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Novocure's electric field therapy fails Phase 3 glioblastoma trial, not extending patient survival
    Novocure announced on Thursday that its electric fields device, used together with standard chemoradiation, did not improve overall survival for patients with glioblastoma in a Phase 3 trial. The…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Moderna appoints Ester Banque as chief commercial officer and expands Stephen Hoge's responsibilities
    Moderna announced a leadership reshuffle as it readies for upcoming product launches. The company named Ester Banque, who previously led U.S. operations at animal health firm Zoetis, as its new ch…
    Endpoints · 2mo agoNeutral↗ source
  • Eli Lilly's TuneLab AI platform reaches 100 members and integrates Chai's models
    Eli Lilly has built TuneLab, an AI initiative that gives biotech companies free access to a range of artificial‑intelligence tools to support drug discovery and development. The program recently a…
    Endpoints · 2mo agoPositive↗ source
  • RA Capital, Forbion and Sanofi Ventures back Korean eye-drug startup
    RA Capital, Forbion and Sanofi Ventures are reported to be providing financing for a new eye-drug company that is developing its product in Korea. The investment follows a growing pattern where la…
    Endpoints · 2mo agoDealNeutral↗ source
  • Innoviva revives Lyndra's long-acting oral drug platform
    Innoviva, a healthcare asset and royalties holding firm, announced it is bringing back Lyndra's long-acting oral drug delivery platform. The technology, which previously attracted more than $380 mi…
    Endpoints · 2mo agoPositive↗ source
  • Industry eyes revenue potential of next‑generation peptide drugs beyond GLP‑1
    The article notes that just a few years ago analysts were busy estimating the market size for GLP‑1 based weight‑loss medicines. Today the conversation has shifted toward the commercial possibilit…
    Endpoints · 2mo agoNeutral↗ source
  • Antifungal from F2G, Shionogi succeeds in Phase 3 study
    F2G and Shionogi released positive Phase 3 data on Thursday morning, giving the companies a potentially clear path to approval for their antifungal drug. The companies said their treatment called o…
    Endpoints · 2mo ago↗ source
  • Kardigan extends biotech’s streak of big IPOs with $400M haul
    Including the heart drug developer’s offering, four biotechs in 2026 have raised at least $400 million in IPO proceeds — the most in a single year since 2021, according to BioPharma Dive data.
    BioPharma Dive · 2mo ago↗ source
  • Kardigan raises $400M in IPO to back three clinical-stage cardio drugs
    More evidence has arrived that biotech IPOs are alive and well: A cardiology drug developer with three clinical-stage candidates just secured $400 million for its Nasdaq debut slated for Thursday.…
    Endpoints · 2mo ago↗ source
  • Biogen makes up to $1B deal for secretive anti-inflammatory biotech
    Biogen will pay as much as $1 billion — “predominantly” in milestone payments — to acquire a San Diego biotech that has disclosed little about its pipeline. The startup, RayThera, debuted last year…
    Endpoints · 2mo ago↗ source
  • FDA gives rejected drugs another chance in post-Makary era
    Did you receive a complete response letter in the past year? Now may be the time for a resubmission. In the wake of FDA Commissioner Marty Makary's departure last month, the agency has already agre…
    Endpoints · 2mo ago↗ source
  • FDA warns telehealth companies over compounded GLP-1s
    The FDA has issued a new batch of warning letters to 25 telehealth companies, accusing them of making false and misleading claims in their marketing of compounded GLP-1 weight loss drugs. The lette…
    Endpoints · 2mo ago↗ source
  • UniQure to file gene therapy for approval, reflecting major shifts at FDA
    The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.
    BioPharma Dive · 2mo ago↗ source
  • UK waitlist for Novo's Wegovy pill triples in week after approval, major online pharmacy says
    The waiting list at a UK online pharmacy for Novo Nordisk’s Wegovy pill now stands at 30,000 people a week after approval, in a sign of dramatic demand for the weight loss drug among patients ...
    Endpoints · 2mo ago↗ source
  • Hackers claim they stole Novo Nordisk AI models, manufacturing recipes
    Novo Nordisk got robbed and is in the unenviable position of being extorted by the thieves. At stake, according to a group that has claimed responsibility for a cyberattack, are some of Novo's most…
    Endpoints · 2mo ago↗ source
  • In second reversal, FDA gives uniQure a green light to seek accelerated approval
    Regulatory flexibility appears to be back on the FDA’s menu following the departures of Marty Makary and Vinay Prasad. At the center of the debate, once again, is the ...
    Endpoints · 2mo ago↗ source
  • Jazz zeroes in on next-gen T cell engagers with AbCellera deal
    The potentially $4 billion collaboration is the latest example of drugmakers working to broaden the use of T cell engagers, which, so far, have had limited success outside of certain blood cancers.
    BioPharma Dive · 2mo ago↗ source
  • Jazz turns to AbCellera for T cell engagers in up to $4.1B partnership
    For much of its first decade, Canadian antibody developer AbCellera signed partnership after partnership, securing 40 biopharma alliances that led to more than a dozen clinical-stage drug candidate…
    Endpoints · 2mo ago↗ source
  • Update: Spot Bio launches with $40M to study non-viral gene therapy for muscular dystrophy
    A startup with operations in California and China has quietly begun tests of a genetic medicine that could restore dystrophin, the vital muscle protein that is broken or missing in people born with…
    Endpoints · 2mo ago↗ source
  • Triveni Bio raises $65M ahead of upcoming readouts on eczema drugs
    Triveni Bio announced a $65 million Series C after its second asset for eczema entered clinical studies last month. The Series C was co-led by Ascenta Capital and Janus Henderson Investors and incl…
    Endpoints · 2mo ago↗ source