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  • 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 immunoglobu…
    Endpoints · 17d 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…
    Endpoints · 17d 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 pro…
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Endpoints · 17d 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 $1…
    Endpoints · 17d 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 · 17d 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! Bu…
    Endpoints · 17d 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 · 17d 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 The…
    Endpoints · 17d 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 fo…
    Endpoints · 18d 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 Thurs…
    Endpoints · 18d 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 · 18d 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 revie…
    Endpoints · 18d 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 dru…
    Endpoints · 18d 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 · 18d 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 he…
    Endpoints · 18d 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…
    Endpoints · 18d 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…
    Endpoints · 18d 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 · 20d 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 mak…
    Endpoints · 21d 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 · 22d 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 · 22d 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…
    Endpoints · 22d 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 · 22d 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 · 22d 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 stabil…
    Endpoints · 22d ago↗ source