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  • 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
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  • 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
  • CMS launches ACCESS program to reward Medicare digital health solutions that improve outcomes
    The Centers for Medicare & Medicaid Services introduced the ACCESS program, a new initiative that invites digital health companies to participate in Medicare. The program ties Medicare payments to…
    Endpoints · 1mo agoRegulatoryPositive↗ 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
  • Novartis, Vertex and Ipsen announce new acquisitions as M&A activity surges in early July 2026
    Biopharma’s merger and acquisition engine remains robust, with four companies revealing new deals within the first six days of July. The announcements add to a total of 45 acquisitions reported in…
    Endpoints · 1mo agoDealPositive↗ source
  • 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
  • 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
  • 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
  • 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
  • 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 · 1mo 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 · 1mo 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 · 1mo ago↗ source