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  • GSK completes $10.6 billion acquisition of Nuvalent, the largest in its history
    GSK announced it has completed a $10.6 billion purchase of Nuvalent, marking the biggest deal the company has ever undertaken. The transaction was disclosed on Tuesday and values Nuvalent at $124…
    Endpoints · 5mo agoDealNeutral↗ source
  • FDA clears Dexcom's Stelo as first OTC continuous glucose monitor for children
    The U.S. Food and Drug Administration cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in children two years of age and older who do not use insulin. This is the first OTC…
    fda press · 5mo agoApprovalPositive↗ source
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  • Enliven Therapeutics raises $400M as Jazz's Zepzelca misses confirmatory trial
    Enliven Therapeutics, a biotech based in Burlingame, California, announced that it priced a public offering of its common stock that raised about $400 million. The capital raise follows the compan…
    Endpoints · 5mo agoDealNeutral↗ source
  • Novo's M&A head joins Forbion as Perrigo CEO steps down over conduct concerns
    Novo's senior M&A executive has left the company to take a role at Dutch investment firm Forbion. Forbion, which manages a portfolio of biotech companies, has been active in M&A and aims to increa…
    Endpoints · 5mo agoNeutral↗ source
  • Amgen seeks FDA review of Tavneos to determine continued market availability
    Amgen has formally asked the U.S. Food and Drug Administration to re-examine the data supporting its drug Tavneos (avacopan). Tavneos is indicated for a rare form of vasculitis and the request sig…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • Eli Lilly backs health-tech startup Abridge to expand clinical trial recruitment
    Eli Lilly’s venture arm has made an investment in Abridge, a health‑technology company that is moving into the clinical trial recruitment space. The funding is intended to help Abridge broaden its…
    Endpoints · 5mo agoDealPositive↗ source
  • Rapport Therapeutics says it is ready to launch its seizure drug independently
    In a recent interview, CEO Abe Ceesay explained that Rapport Therapeutics has assembled an investor syndicate and feels fully prepared to bring its seizure drug to market on its own. Founded in 20…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • Sciwind Biosciences seeks additional partners for obesity drug ecnoglutide after deals with Pfizer and Verdiva Bio
    Sciwind Biosciences, a Chinese biotech, has licensed its GLP-1 obesity candidate ecnoglutide to two Western companies. The first agreement grants Pfizer rights to develop and commercialize the dru…
    Endpoints · 5mo agoDealPositive↗ source
  • WuXi AppTec Files Lawsuit Against Pentagon Over Chinese Military Designation
    WuXi AppTec, a major contract manufacturing organization in China, has filed a lawsuit in U.S. federal court. The suit challenges the U.S. Department of Defense's decision to place the company on…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • Biopharma exec pay reveals quirky perks like private jets and wildfire relief grants
    A recent review of thousands of biopharma C‑suite compensation packages found that most line items blend into the massive totals, but a few stand out for their unusual nature. Among the highlighte…
    Endpoints · 5mo agoNeutral↗ source
  • J&J reports positive Phase 2/3 results for Imaavy in rare autoimmune anemia, paving way for label expansion
    Johnson & Johnson announced that its drug Imaavy, already approved for myasthenia gravis, produced durable hemoglobin improvements in a Phase 2/3 trial for warm autoimmune hemolytic anemia, a rare…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • Takeda’s experimental TYK2 inhibitor zasocitinib outperforms Bristol Myers’ Sotyktu in psoriasis trial
    Takeda announced that its experimental TYK2 inhibitor zasocitinib showed statistical superiority over Bristol Myers Squibb’s approved psoriasis drug Sotyktu in a head‑to‑head study. The 16‑week tr…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • Actuaries predict continued rise in healthcare costs for next year
    A recent survey of actuaries from 27 health plans that serve both employer groups and individual exchange markets shows early signs of where health-care spending is headed. The respondents expect…
    Endpoints · 5mo agoNegative↗ source
  • Summit Therapeutics cancels $500 million secondary share offering citing market conditions
    Summit Therapeutics announced it would pull a planned $500 million secondary share sale just one day after the announcement, saying market conditions were unfavorable. The offering had been slated…
    BioPharma Dive · 5mo agoDealNegative↗ source
  • DHL in talks with major pharma firms to manage sites amid ongoing trade disruptions
    DHL's healthcare logistics division is currently in discussions with several leading pharmaceutical manufacturers. The drugmakers are exploring options for DHL to either assume control of their ma…
    Endpoints · 5mo agoDealNeutral↗ source
  • Summit Therapeutics cancels $500 million public offering amid weak market conditions
    Summit Therapeutics announced it is no longer pursuing a $500 million public offering, citing unfavorable market conditions. The biotech sector has recently seen record‑setting initial public offe…
    Endpoints · 5mo agoDealNegative↗ source
  • Novartis' RNA drug del-brax hits primary endpoint in early-stage FSHD trial
    Novartis reported that its antisense oligonucleotide conjugate, del-brax, achieved the primary biomarker endpoint in a Phase 1/2 study of patients with facioscapulohumeral muscular dystrophy (FSHD)…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • Kardigan targets $320 million IPO to fund three late-stage heart drugs
    Kardigan, a biotech focused on cardiovascular therapies, announced plans for an initial public offering that aims to raise about $320 million. The proceeds are intended to support the development…
    Endpoints · 5mo agoDealNeutral↗ source
  • FDA grants emergency use authorization for generic Nitenpyram tablets to treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for generic Nitenpyram tablets to treat New World screwworm infestations in dogs, puppies, cats and kittens that weig…
    fda press · 5mo agoRegulatoryPositive↗ source
  • Takeda’s oral psoriasis drug outperforms Bristol Myers’ Sotyktu in Phase 3 trial
    Takeda announced that its experimental oral medication for plaque psoriasis achieved superior results compared with Bristol Myers Squibb’s Sotyktu in a head-to-head Phase 3 study. The trial measur…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Genentech shuts infectious disease research unit and lays off senior scientists in latest R&D cuts
    Genentech announced another round of layoffs affecting its early research and development group. The cuts included the closure of its infectious disease research unit and the departure of several…
    Endpoints · 5mo agoLayoffsNegative↗ source
  • Camurus receives second complete response letter for acromegaly drug CAM2029; Teva announces workforce reductions
    Camurus reported that the FDA issued a second complete response letter for its investigational acromegaly therapy CAM2029, citing issues related to a third‑party manufacturer. The agency’s concern…
    Endpoints · 5mo agoCRLNegative↗ source
  • Neion Bio secures $23M Series A to develop egg-based protein platform for biologics
    Neion Bio announced it closed a $23 million Series A round that was oversubscribed. The funding will be used to advance its platform that leverages chicken eggs, extracting primordial germ cells f…
    Endpoints · 5mo agoDealPositive↗ source
  • Sensorion drops OTOF gene therapy to focus on GJB2-targeted hearing loss candidate after Regeneron approval
    Sensorion said it is ending development of its gene therapy SENS-501 for OTOF related hearing loss after a strategic review. The review concluded that the competitive landscape had changed signific…
    BioPharma Dive · 5mo agoNeutral↗ source
  • Sensorion halts development of SENS-501 for OTOF-related hearing loss after strategic review
    Sensorion announced it is ending the development of its SENS-501 candidate, which was aimed at treating OTOF-related hearing loss, following a strategic review of its pipeline. The biotech said it…
    Endpoints · 5mo agoNeutral↗ source