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671 stories matching this filter · ← front page

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  • 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 · 23d 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…
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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 · 27d 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 · 27d 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 · 27d 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 · 27d 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 · 28d 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 · 28d ago↗ source
  • IPF biotech Celea gets $180M to follow paths of PureTech's Karuna, Seaport
    With major backing from new investors, Celea Therapeutics hopes to follow in the footsteps of its siblings Seaport Therapeutics and Karuna Therapeutics. Celea has corralled $180 million to see if
    Endpoints · 28d ago↗ source
  • Vertex's sickle cell therapy approved for kids; United Therapeutics buys startup
    🧬 Vertex’s sickle cell gene therapy approved for kids: Casgevy may now be used to treat either sickle cell disease with recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia patie…
    Endpoints · 28d ago↗ source
  • Galderma gets CRL for anti-wrinkle drug; Kimball buys CDMO for $103M
    Plus more from Lonza, Icosagen and others. 🟥 Galderma’s CRL: Galderma has received a complete response letter from the FDA for its relabotulinumtoxinA, a drug being reviewed as a neuromodulator to…
    Endpoints · 28d ago↗ source
  • How Butterfly, once known for its handheld ultrasound device, is growing its chip-making business
    Nvidia got its start as a gaming chip maker before meteoric success selling its chips to nearly every industry. One health tech company is hoping to go down a similar route. Last month, ultrasound…
    Endpoints · 28d ago↗ source
  • Roche’s KRAS G12C inhibitor beats rivals in head-to-head Phase 3 study
    Roche’s lung cancer drug candidate divarasib has beaten marketed drugs from Amgen and Bristol Myers Squibb in a head-to-head trial. Full data haven't yet emerged, but if the drug's survival benefit…
    Endpoints · 28d ago↗ source
  • Ex-iTeos CEO starts fresh at GSK neuro partner; Genentech loses yet another key scientist
    → Michel Detheux has succeeded Rita Balice-Gordon as CEO of Danish neuro biotech Muna Therapeutics, which is partnering with GSK on Alzheimer’s treatments. Balice-Gordon will slide over to ...
    Endpoints · 28d ago↗ source
  • BrightGene looks to the West as obesity shot nears China approval
    Armed with impressive Phase 3 data, BrightGene is taking its obesity shot to Chinese regulators. It expects trial data in the West to be even stronger, but its search for a partner for ex-China ter…
    Endpoints · 28d ago↗ source
  • Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
    Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
    fda medwatch · 28d ago↗ source
  • Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
    The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
    fda medwatch · 28d ago↗ source
  • Merck scraps a Phase 2 Alzheimer's asset from partner Neuphoria
    Merck has axed a Phase 2 trial testing an experimental Alzheimer’s medicine, Endpoints News has learned. The company terminated a mid-stage test of the oral drug candidate MK-1167, a Merck spokespe…
    Endpoints · 28d ago↗ source