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  • Genentech pours $750M into new drug‑delivery device plant in Oregon; Bavarian Nordic pushes back Lyme vaccine trial
    Roche’s Genentech announced a $750 million investment to build a new drug‑delivery device manufacturing facility at its Hillsboro, Oregon campus. The plant is intended to expand the company’s capac…
    Endpoints · 1h agoDealNeutral↗ source
  • New study warns that Trump-era cuts to federal research could jeopardize cancer drug development
    A recent study examines how recent political moves to curtail federally funded research could affect cancer drug development. The analysis notes that over the past decade biopharma companies have…
    Endpoints · 2h agoRegulatoryNegative↗ source
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  • Replimune appoints former Genentech exec Michelle DiNapoli as chief commercial officer after accelerated melanoma approval
    Replimune announced that Michelle DiNapoli will become its chief commercial officer, starting August 18. DiNapoli previously held senior roles at Genentech, where she led commercial operations. Th…
    Endpoints · 4h agoPositive↗ source
  • GOP lawmakers urge FDA to reject Chinese trial data unless sites undergo recent agency audit
    Two Republican members of the U.S. House have asked the Food and Drug Administration to tighten its oversight of clinical data that originates from China. Their proposal would require the FDA to r…
    Endpoints · 4h agoRegulatoryNegative↗ source
  • California chronic pain biotech co‑founded by Vivek Ramaswamy to go public via reverse merger
    A California biotech company that has developed a chronic pain medication already approved for use in Italy is preparing to list on a U.S. exchange. The firm, co‑founded by entrepreneur Vivek Rama…
    Endpoints · 32m agoDealNeutral↗ source
  • Werewolf transforms into Ambros via reverse merger to support phase 3 push for rare disease drug
    Werewolf Therapeutics’ hunt for strategic alternatives has ended. Ambros Therapeutics has agreed to merge with Werewolf in an all-stock deal and raised $150 million, positioning the biotech to take…
    Fierce Biotech · 6h ago↗ source
  • Moderna's cancer vaccine boost lifts stock, sparks talk of Keytruda-like reach
    Moderna’s shares surged 177% after a phase 3 topline win for its Merck‑partnered cancer vaccine, intismeran autogene, was disclosed. The data, released on Wednesday, added roughly $45 billion to Mo…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 1d agoApprovalPositive↗ source
  • Gray‑market copies of Lilly’s obesity drug retatrutide show weaker weight‑loss results, study finds
    A recent study examined the effectiveness of gray‑market versions of Eli Lilly’s triple‑agonist obesity drug retatrutide. The analysis found that patients using these unapproved copies experienced…
    Endpoints · 1d agoNegative readoutNegative↗ source
  • FDA grants approval to Ultragenyx's Genglycos gene therapy for ultra-rare glycogen storage disorder
    Ultragenyx announced that the U.S. Food and Drug Administration has approved its gene therapy called Genglycos. The therapy targets an ultra-rare glycogen storage disorder that can lead to severe…
    Endpoints · 1d agoApprovalPositive↗ source
  • Three deaths in China’s investigator-initiated trials raise concerns over fast, low-cost clinical testing
    Three participants died while taking part in investigator-initiated trials in China, prompting renewed scrutiny of the country’s clinical testing practices. China’s system is prized for its low co…
    Endpoints · 21h agoRegulatoryNegative↗ source
  • Eli Lilly teams with Amplitude on taRNA vaccine platform as Otsuka ends psychedelic trial
    Eli Lilly announced a collaboration with Amplitude Therapeutics to co‑develop vaccine candidates using a trans‑amplifying RNA (taRNA) platform. The taRNA approach aims to boost antigen expression…
    Endpoints · 1d agoDealNeutral↗ source
  • Chai Discovery partners with Bristol Myers Squibb to use AI for antibody discovery
    Chai Discovery, an AI-driven drug discovery company, announced a collaboration with Bristol Myers Squibb to apply its artificial-intelligence models to therapeutic antibody research. The partnershi…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Eli Lilly partners with Amplitude Therapeutics to develop trans-amplifying RNA vaccines for infectious diseases
    Eli Lilly announced a collaboration with Boston-based Amplitude Therapeutics, a company that emerged from Lilly’s Gateway Labs incubator. The partnership will focus on developing trans-amplifying…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Medline recalls convenience kits with B. Braun bupivacaine component, urges correction before use
    Medline has issued a correction for a range of its convenience surgical kits after discovering that they contain components from B. Braun Medical that include bupivacaine hydrochloride in a dextros…
    fda medwatch · 1d agoCRLNegative↗ source
  • FDA rejects Osteal Therapeutics' combo therapy for joint-implant infections
    The U.S. Food and Drug Administration rejected Osteal Therapeutics' lead combination therapy late last month. The agency cited concerns that prevented approval of the product intended to treat infe…
    Endpoints · 22h agoRegulatoryNegative↗ source
  • PhRMA weighs former Republican lawmakers and Trump administration officials for CEO role
    PhRMA, the pharma lobbying group, has been searching for a new chief executive for over four months. The search has focused on candidates with Republican backgrounds, including former members of C…
    Endpoints · 21h agoNeutral↗ source
  • Pheast Therapeutics sticks with open R&D despite competitor Antengene moving ahead with anti‑CD24 trials
    Pheast Therapeutics, a Redwood City biotech founded in 2021, builds on Irv Weissman’s 2019 Nature paper that highlighted the CD24 protein as a promising "don’t eat me" target for cancer immunothera…
    Fierce Biotech · 1d agoNeutral↗ source
  • FDA expands TEMPO pilot with new digital health partners Limbic, Cadence and Dexcom
    The FDA is quietly building a pilot program called TEMPO to test a “try first, evaluate later” approach for digital health devices. The agency has added the behavioral‑health firm Limbic to the ro…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • WuXi Bio sells majority stake in chromatography resin maker Bestchrom; Cabaletta adds new CDMO partner
    WuXi Bio announced it will divest its 51.1% equity interest in Bestchrom, a Shanghai-based supplier of chromatography resins. The sale will transfer control to an unnamed third party, marking WuXi…
    Endpoints · 1d agoDealNeutral↗ source
  • Boehringer Ingelheim pauses phase 1 trial of BI 3031185 in Japan to investigate safety event
    Boehringer Ingelheim has placed a phase 1 study of its investigational oral small‑molecule candidate BI 3031185 on voluntary hold after a safety event was reported. The trial, which began in early…
    Fierce Biotech · 1d agoCRLNeutral↗ source
  • Epic expands AI tools for clinicians and patients, intensifying competition for health-tech startups
    Epic highlighted its growing portfolio of artificial‑intelligence applications for both clinicians and patients at its annual Users Group Meeting in Verona, Wisconsin. The presentation showcased ne…
    Endpoints · 1d agoNeutral↗ source
  • Chutes & Ladders—Neumora shuffles leadership ahead of IND
    Joshua Pinto, Ph.D., has been appointed chief executive officer of Neumora Therapeutics, a clinical-stage biotech with obesity and neuro assets.
    Fierce Biotech · 1d ago↗ source
  • FDA approves Regeneron’s garetosmab for ultra-rare bone-forming disease
    The FDA has granted approval to Regeneron's antibody garetosmab, which targets activin A, for the treatment of fibrodysplasia ossificans progressiva (FOP). FOP is an ultra‑rare disorder that causes…
    Endpoints · 1d agoApprovalPositive↗ source
  • Merck and Moderna report Phase 3 success for personalized mRNA cancer vaccine intismeran autogene
    Merck and Moderna announced on August 19, 2026 that their personalized mRNA cancer vaccine, intismeran autogene, has completed a successful Phase 3 trial. The collaboration aims to create a patient…
    Endpoints · 2d agoPositive readoutPositive↗ source