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1,349 stories matching this filter · ← front page

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  • MeiraGTx secures $135 million royalty deal with Oberland Capital
    MeiraGTx announced a royalty financing agreement with Oberland Capital. The deal provides the gene-therapy company with an initial $135 million, including a $10 million equity investment from Oberl…
    Endpoints · 1mo agoDealPositive↗ source
  • Fresenius Kabi issues correction for Ivenix infusion pumps over battery health software bug
    The U.S. Food and Drug Administration has classified a correction for Fresenius Kabi’s Ivenix Large Volume infusion pump as the most serious type of recall. The action does not require removal of t…
    fda medwatch · 1mo agoCRLNegative↗ source
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  • Tampa General Hospital sues Eli Lilly over 340B discount halt
    Tampa General Hospital filed a lawsuit against Eli Lilly, alleging the drugmaker stopped providing 340B program discounts to the hospital. The dispute centers on Lilly's new requirement that hospi…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Compass Pathways reports six-month durability of response in pivotal psilocybin depression trial
    Compass Pathways announced that patients in the second of its two pivotal psilocybin trials for depression continued to show a therapeutic response for at least six months. The durability data sugg…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction
    Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become un…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Digital health firms eye CMS ACCESS Medicare pilot despite modest reimbursement
    A new Medicare initiative called CMS ACCESS is being launched to manage chronic diseases among seniors. The program will contract digital health companies to provide remote monitoring and other se…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Cyllene Therapeutics raises €33 million to pursue HSV-based gene therapy after Krystal model
    Cyllene Therapeutics, a French-US biotech, announced it has secured €33 million in financing. The capital will be used to develop HSV-based gene therapy programs, aiming to replicate the approach…
    Endpoints · 1mo agoDealPositive↗ source
  • Vertex to acquire Crinetics in $10 billion deal to expand endocrinology portfolio
    Vertex Pharmaceuticals announced it will acquire Crinetics Pharmaceuticals for $10 billion, the largest purchase in the company's history. The transaction is aimed at broadening Vertex's commercia…
    Endpoints · 1mo agoDealPositive↗ source
  • AbbVie completes $10.9 billion acquisition of Apogee Therapeutics as UK launches drug pricing pilot
    AbbVie, the Chicago-based pharmaceutical company, finalized its purchase of Apogee Therapeutics for $10.9 billion last month, ending a multi-year negotiation process. The transaction brings Apogee…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA approves 23 new drugs in first half, marking best pace in three years despite staff cuts
    The FDA announced that it has approved 23 novel drugs during the first half of 2026, the strongest approval count in three years. The approvals come after the Trump administration reduced FDA staf…
    Endpoints · 1mo agoApprovalPositive↗ source
  • CMS proposes rule to slash Medicare 340B drug payments by over a third
    CMS announced a proposed rule that would reduce the rates Medicare uses to reimburse hospitals for drugs purchased through the 340B program. The reduction would be more than one-third, effectively…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Novartis to spend $1.1 billion upfront acquiring Myricx Bio and its next-gen ADC platform
    Novartis announced Monday it will invest $1.1 billion in an upfront payment to acquire Myricx Bio. Myricx Bio brings an antibody-drug conjugate (ADC) payload platform that the Swiss group believes…
    Endpoints · 1mo agoDealPositive↗ source
  • Bristol Myers reports Krazati confirmatory trial fails in colorectal cancer
    Bristol Myers Squibb disclosed that the confirmatory study of its investigational drug Krazati in combination with an EGFR inhibitor did not achieve its primary efficacy endpoints in patients with…
    Endpoints · 1mo agoCRLNegative↗ source
  • Roche partners with Otsuka's Astex in $25 million deal to strengthen breast cancer pipeline
    Roche's Genentech subsidiary has signed a collaboration with Astex Pharmaceuticals, a unit of Otsuka, that includes a $25 million upfront payment. The partnership is an early‑stage effort aimed at…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA CDER appoints veteran GLP-1 reviewer Lisa Yanoff as acting deputy director
    Acting FDA CDER director Michael Davis promoted Lisa Yanoff to the role of acting deputy director of the Center for Drug Evaluation and Research. Yanoff is a long‑time FDA employee with deep exper…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Salk Institute President Warns of NIH Funding Cuts While Embracing AI and Brain Research Initiatives
    Gerald Joyce, president of the Salk Institute, highlighted recent reductions in NIH funding and their impact on research institutions. He said the institute is fully committing resources to artifi…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
    Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
    fda medwatch · 1mo ago↗ source
  • Anthropic launches Claude Science; House China panel probes trial sites; and more
    Happy Fourth of July! We’ve got a handful of stories worth checking out before the backyard barbecue begins. But first: a reminder to submit your nominations for this year’s Women in Biopharma ...
    Endpoints · 1mo ago↗ source
  • When clinical AI gets real
    We’re heading toward a future in which certain parts of medical care are delivered without any humans involved. Cadence, which raised a $100 million Series C last week, is betting that it can make…
    Endpoints · 1mo ago↗ source
  • Scribe Therapeutics files for IPO in test of appetite for early-stage biotechs
    Scribe Therapeutics filed for a Nasdaq IPO late Thursday. The move marks a pivotal moment for the biotech and the gene editing field. The novel CRISPR enzyme developer was created nine ...
    Endpoints · 1mo ago↗ source
  • Sandoz launches direct-to-consumer platform with growth disorder drug
    Sandoz unveiled a direct-to-consumer platform, starting off with a single medication for now as the generic drugmaker adopts a system that several brand-name manufacturers are using to cut out-of-p…
    Endpoints · 1mo ago↗ source
  • After landmark deal, AstraZeneca goes to CSPC again in up to $1.7B pact
    Less than six months after lining up one of the largest biobucks packages in industry history, AstraZeneca is returning to the same Chinese partner for another drug R&D collaboration. The UK pharma…
    Endpoints · 1mo ago↗ source
  • Court halts Colorado price cap on Amgen's blockbuster Enbrel
    US District Court Judge Daniel Domenico in Colorado granted Amgen's preliminary injunction to stop a 70% price cap on its blockbuster autoimmune drug Enbrel, arguing that the cap could cause "econo…
    Endpoints · 1mo ago↗ source
  • Revolution Medicines shares promising data around KRAS drug combination
    Revolution Medicines on Thursday gave a first look at the early-stage data that led it to plan a Phase 3 trial combining two KRAS drugs in pancreatic cancer. One of the two drugs is a ...
    Endpoints · 1mo ago↗ source
  • Otsuka reports long-term kidney data key to Voyxact's bid for full approval
    Otsuka on Thursday reported new long-term data that it hopes will convert an accelerated approval to a full green light in kidney disease. The company said the Phase 3 study showed Voyxact stabiliz…
    Endpoints · 1mo ago↗ source