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  • Tampa General kicks off legal fight over Lilly's 340B restrictions
    Tampa General Hospital sued Eli Lilly for halting its 340B discounts, kicking off a broader fight over whether pharmaceutical companies can condition drug discounts on new claims data requirements.…
    Endpoints · 23d ago↗ source
  • Vera's IgAN approval kicks off competition with Otsuka
    Vera Therapeutics’ fusion protein atacicept got an accelerated approval on Tuesday for a chronic autoimmune disease that damages the kidneys. The drug will be marketed as Trutakna for immunoglobuli…
    Endpoints · 23d ago↗ source
  • Compass Pathways touts durability data for psilocybin drug in depression ahead of year-end filing
    Compass Pathways said Tuesday that patients in the second of its two pivotal psilocybin trials maintained their response to treatment for at least six months, keeping the company on track to comple…
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Endpoints · 23d ago
↗ source
  • Hengrui, Kailera's GLP-1 pill posts encouraging efficacy but high side effect rates in late-stage China trials
    The GLP-1 pill being developed by Hengrui Pharma and Kailera Therapeutics posted decent results in two late-stage China-based trials — one in obesity and the other in diabetes. But the safety profi…
    Endpoints · 23d ago↗ source
  • Novartis, Vertex and Ipsen extend pharma M&A spree from 2026's first half
    Biopharma's M&A engine is revved up and shows no signs of cooling off. Four companies have announced acquisitions in the first six days of July, forging deals that could pay out as much as $12.6 ...
    Endpoints · 23d ago↗ source
  • MeiraGTx strikes royalty deal; Fore's 2023 Series D continues
    Plus, news about Kalohexis, Teva and Agios: 👑 MeiraGTx makes royalty deal with Oberland Capital: The gene therapy maker will get an initial $135 million via a $10 million equity investment ...
    Endpoints · 23d ago↗ source
  • Conquering Medicare's ACCESS program
    There was so much excitement when CMS announced the ACCESS program. Finally, a way for digital health companies to make their mark on Medicare! A program that pays only if patients get better! But…
    Endpoints · 23d ago↗ source
  • How digital health companies are planning to conquer CMS ACCESS
    A new Medicare experiment to manage seniors’ chronic diseases will pay some digital health companies only about as much in a year as they might earn for a couple of patient visits from commercial i…
    Endpoints · 23d ago↗ source
  • French gene therapy biotech gets €33M to follow Krystal's blueprint
    A small French-US biotech has gathered more funds to see if it can follow in the footsteps of Krystal Biotech in the HSV-based gene therapy field, but in a different therapeutic area. Cyllene Thera…
    Endpoints · 23d ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
    A software anomaly may cause a false battery-health value. The pump should remain plugged in at all times.
    fda medwatch · 23d ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
    If dropped, the Ivenix pump touchscreen may become unresponsive and should be removed from use.
    fda medwatch · 23d ago↗ source
  • Vertex makes $10B deal for commercial endocrinology biotech Crinetics
    Vertex Pharmaceuticals is making the largest acquisition in its history, beefing up its commercial portfolio with a $10 billion takeover of Crinetics Pharmaceuticals. The Monday afternoon deal for…
    Endpoints · 24d ago↗ source
  • CMS proposes 340B cuts
    A proposed rule would cut the rates by which Medicare pays hospitals for 340B drugs by more than a third, reviving a similar policy introduced by the first Trump administration. CMS said on Thursda…
    Endpoints · 24d ago↗ source
  • FDA approves 23 new drugs in first half, overcoming staff-cut concerns
    There's an answer emerging on the multibillion-dollar question of whether the Trump administration's gutting of FDA staff in April 2025 would slow down drug approvals: So far, so good. In the
    Endpoints · 24d ago↗ source
  • New CDER appointment elevates longtime GLP-1 reviewer
    Acting FDA CDER director Michael Davis has promoted a longtime FDA staffer as an acting deputy director at the drug center. Lisa Yanoff, an agency veteran with expertise in metabolic drug reviews,…
    Endpoints · 24d ago↗ source
  • Bristol Myers details Krazati confirmatory study failure in colorectal cancer
    While Americans geared up for the July 4 holiday, Bristol Myers Squibb laid out how a confirmatory trial for its drug Krazati failed in colorectal cancer. Patients taking Krazati plus another drug,…
    Endpoints · 24d ago↗ source
  • Roche aims to bolster breast cancer pipeline with early-stage Astex deal
    Monday’s deal between Otsuka’s subsidiary Astex Pharmaceuticals and Roche’s subsidiary Genentech is of interest not because it is big money — the upfront fee is just $25 million — but because of wh…
    Endpoints · 24d ago↗ source
  • Apogee details path to $10.9B AbbVie deal; UK starts drug pricing pilot
    Plus news about Brii Biosciences. 💰 How AbbVie got Apogee: The Chicago-area drug giant snagged Apogee Therapeutics for $10.9 billion last month after years of talking with the biotech. AbbVie held…
    Endpoints · 24d ago↗ source
  • Salk Institute’s president on NIH cuts, ‘all in’ on AI, and the Year of the Brain
    SAN DIEGO — From the president’s office at the Salk Institute, Gerald Joyce has a quintessential California view of hang gliders soaring over the Pacific Ocean. It’s been a little more turbulent fo…
    Endpoints · 24d ago↗ source
  • Novartis commits $1.1B upfront to take Myricx Bio and its next-gen ADC platform
    Novartis said Monday it will be spending $1.1 billion upfront to buy Myricx Bio, which has an antibody-drug conjugate payload platform that could offer an edge over current approaches. The Swiss dr…
    Endpoints · 24d ago↗ 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 · 24d 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 · 26d 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 · 27d 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 · 28d 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 · 28d ago↗ source