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  • Senate introduces BINSA bill to tighten review of China biotech and pharma transactions
    The U.S. Senate has introduced the Biotech Innovation and National Security Act (BINSA), a bill that would tighten oversight of biotech and pharmaceutical transactions involving China. The proposa…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • FDA schedules September advisory panel to review Grail's cancer test after trial miss
    The FDA announced it will hold an advisory committee meeting in September to examine Grail's multi‑cancer early detection test. The test recently failed to meet its primary endpoint in a large, ra…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
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  • Latigo Biotherapeutics raises $345.6M in IPO to fund non-opioid pain drug pipeline
    Latigo Biotherapeutics, a Los Angeles-based biotech focused on non-opioid ion-channel-blocking pain therapies, completed an initial public offering on Thursday. The company sold 19.2 million share…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • BlossomHill and Latigo close IPO week with $496 million raised
    BlossomHill Therapeutics, a cancer‑focused biotech, completed its initial public offering this week. Latigo, a company developing non‑opioid pain treatments, also went public at the same time. To…
    Endpoints · 3mo agoDealPositive↗ source
  • Johnson & Johnson’s Global Chair of Innovative Medicine Jennifer Taubert Announces Retirement
    Jennifer Taubert, who leads Johnson & Johnson Innovative Medicine worldwide, has said she will step down from her role later this year. The company indicated that Tom (last name not disclosed) wil…
    Endpoints · 3mo agoNeutral↗ source
  • Lexunder’s Food to Live green powder recalled over possible Salmonella contamination
    Lexunder Inc., operating as Food to Live, announced a recall of its green powder products due to potential Salmonella contamination. The recall covers products sold nationwide in resealable pouche…
    fda recalls · 3mo agoCRLNegative↗ source
  • BioMarin halts development of BMN401 enzyme therapy after mixed Phase 3 results
    BioMarin announced it will stop work on BMN401, an enzyme replacement therapy aimed at treating ENPP1 deficiency, a rare genetic disorder. The decision follows a Phase 3 trial that produced mixed…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Pfizer exec says China's biotech growth will decelerate as firms hit R&D frontier
    Andrew Baum of Pfizer told Endpoints News that China's rapid biotech progress is expected to slow as companies move into more advanced research and development. He explained that as Chinese firms…
    Endpoints · 3mo agoNeutral↗ source
  • FDA grants emergency use authorization for CLiK Extra wound spray to prevent New World screwworm in livestock and wildlife
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for CLiK Extra, a dicyclanil topical suspension designed to be applied around wounds. The authorization allows the pr…
    fda press · 3mo agoRegulatoryPositive↗ source
  • Replimune secures FDA accelerated approval for melanoma therapy after two prior rejections
    Replimune, a biotech based in Massachusetts, has received accelerated approval from the U.S. Food and Drug Administration for its melanoma drug. The approval comes after the therapy was rejected tw…
    Endpoints · 3mo agoApprovalPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 3mo agoApprovalPositive↗ source
  • FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1
    The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class. Orzeyful works by amplifyi…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • FDA approves Moderna's first mRNA flu vaccine for adults 50 and older
    The Food and Drug Administration has granted approval to Moderna's mRNA flu vaccine, called mFlusiva and previously known as mRNA-1010, making it the first preventive flu shot built on messenger RN…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Replimune's oncolytic virus therapy Tudriqev receives FDA accelerated approval for advanced melanoma
    The U.S. Food and Drug Administration has granted approval to Replimune's melanoma treatment, ending a series of earlier rejections after an advisory panel advocated for the drug. The therapy, pre…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Tarsus to acquire eye-drug startup Alkeus in up to $800 million deal
    Tarsus Pharmaceuticals announced Thursday that it will buy Alkeus Pharmaceuticals for up to $800 million, consisting of $270 million in cash and $180 million in stock. The agreement also provides…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Erica Schwartz confirmed as CDC director after year-long leadership void
    Senate confirmed Erica Schwartz, a public-health veteran and vaccine supporter, as the new head of the CDC. She takes over an agency that has operated without a permanent director for almost a yea…
    BioPharma Dive · 3mo agoNeutral↗ source
  • LifeMine secures $263M to advance fungal-derived organ transplant drug
    LifeMine Therapeutics announced it has closed two venture financings that together raised $263 million. The capital will be used to push its experimental therapy, LIFE-001, further along the develo…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Tarsus Pharma to spend $450M upfront acquiring Alkeus to expand its ophthalmology pipeline
    Tarsus Pharmaceuticals announced it will acquire Alkeus Pharmaceuticals, a Phase 3 biotech focused on a Stargardt disease drug, for an upfront payment of $450 million. The deal is intended to broad…
    Endpoints · 3mo agoDealPositive↗ source
  • FDA outlines pilot to speed IND submissions for up to 10 drug programs
    The Food and Drug Administration has released details of a new pilot program designed to accelerate the Investigational New Drug (IND) filing process for selected candidates. The agency plans to w…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Teva agrees to $35 million settlement over delayed generic asthma inhalers
    A Massachusetts federal judge approved a settlement involving Teva Pharmaceuticals and several healthcare funds. The agreement sets the payment at $35 million to resolve the dispute. The funds al…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Intellia finds genetic marker linked to liver enzyme spikes in CRISPR ATTR amyloidosis trial
    Intellia Therapeutics announced that analysis of its ongoing CRISPR gene-editing trial for transthyretin (ATTR) amyloidosis has identified a common genetic variant among participants who experience…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Vedanta Biosciences secures $60 million to complete Phase 3 trial of C. difficile microbiome therapy
    Vedanta Biosciences, a Cambridge, MA biotech focused on microbiome therapeutics, announced it has raised $60 million in new financing. The capital will be used to advance its lead candidate target…
    Endpoints · 3mo agoDealPositive↗ source
  • LifeMine Therapeutics secures $263 million to develop safer transplant immunosuppressant
    LifeMine Therapeutics announced it has raised a total of $263 million through two venture financing rounds. The capital, which includes a newly disclosed $75 million Series D round, will be used t…
    Endpoints · 3mo agoDealPositive↗ source
  • FDA approves Moderna flu vaccine
    The U.S. Food and Drug Administration granted approval to Moderna's seasonal flu vaccine, adding another product to the company's portfolio. The approval was announced late Wednesday, after a repo…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Revolution Medicines readies launch of experimental pancreatic cancer drug daraxonrasib as approval decision pending
    Revolution Medicines executives say they are preparing to launch daraxonrasib, an experimental therapy for metastatic pancreatic cancer. The drug is currently awaiting regulatory decisions in the…
    Endpoints · 3mo agoNeutral↗ source