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  • Novartis announces reduction of 322 jobs at New Jersey facility
    Novartis filed a WARN notice indicating it will eliminate 322 positions at its East Hanover, New Jersey site. The reduction is part of a broader restructuring effort aimed at streamlining operation…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • Sino Biopharm signs separate respiratory partnership deals with AstraZeneca and GSK
    Sino Biopharm announced it has entered into two distinct agreements with UK-based pharmaceutical companies focused on respiratory medicines. One agreement involves licensing its investigational PD…
    Endpoints · 1mo agoDealPositive↗ source
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  • Satellos Bioscience presents early adult data for Duchenne muscular dystrophy pill ahead of child trial
    Satellos Bioscience, a Canadian biotech, has released early results from its Phase 2 study of an oral therapy for Duchenne muscular dystrophy in adult patients. The data are intended to strengthen…
    Endpoints · 1mo agoNeutral↗ source
  • HHS pushes FDA to formalize public release of rejection letters to drug makers
    HHS announced it is preparing a new FDA regulation that would codify the agency's practice of publishing complete response letters (CRLs) that inform pharmaceutical companies of a drug's rejection.…
    Endpoints · 1mo agoCRLNeutral↗ source
  • Biohaven targets muscle-sparing obesity market to compete with Lilly's GLP-1 drugs
    Biohaven is positioning itself to address obesity by developing treatments that preserve lean muscle, a differentiator from existing GLP-1 therapies. The company sees an opportunity to act as a "s…
    Endpoints · 1mo agoNeutral↗ source
  • Sanofi proposes to cease negative statements about CSL's flu vaccine amid EU probe
    Sanofi has offered to stop making disparaging comments about CSL's flu vaccine following an investigation launched by the European Commission. The offer comes two weeks after the Commission began p…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Vertex to acquire endocrinology startup Crinetics for $10 billion, signaling push into new therapeutic areas
    Vertex Pharmaceuticals announced a $10 billion cash purchase of Crinetics, an endocrinology-focused biotech. The deal represents the largest acquisition in Vertex’s history and underscores its pla…
    Endpoints · 1mo agoDealPositive↗ source
  • Vera Therapeutics receives accelerated approval for Trutakna to treat IgA nephropathy
    Vera Therapeutics announced that its fusion protein atacicept, branded as Trutakna, has been granted accelerated approval by the FDA for the treatment of immunoglobulin A nephropathy, a chronic aut…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Hengrui and Kailera's oral GLP-1 pill shows promising efficacy but notable side effects in Chinese obesity and diabetes trials
    Hengrui Pharma and Kailera Therapeutics reported results from two late‑stage trials in China, one targeting obesity and the other diabetes, using their daily oral GLP‑1 pill. The studies demonstrat…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • 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
  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo ago↗ source