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909 stories matching this filter · ← front page

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  • Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal
    An arbitration panel ruled Prime didn’t breach a deal with Beam by developing a rare disease treatment. Elsewhere, European regulators are using a pancreatic cancer drug to test a new framework for…
    BioPharma Dive · 20d ago↗ source
  • Sino Biopharm hooks AstraZeneca, GSK for separate respiratory partnerships
    Sino Biopharmaceutical announced drug development and sales pacts with two UK pharma companies on Wednesday. One will see the Hong Kong biotech license an investigational PDE3/4 inhibitor to AstraZ…
    Endpoints · 20d ago↗ source
  • Satellos gives early look at Duchenne pill in adults ahead of key data in children
    Satellos Bioscience is building its case for a Duchenne muscular dystrophy pill with data in adult patients ahead of a potentially pivotal readout in children later this year. The Canadian biotech’…
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Endpoints · 20d ago↗ source
  • Vertex's Crinetics deal points to big ambitions for cystic fibrosis leader
    Vertex Pharmaceuticals' $10 billion acquisition of an endocrinology startup represents the company’s clearest and boldest step toward the upper echelon of the biopharma industry. Long a biotech suc…
    Endpoints · 21d ago↗ source
  • 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 · 21d 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 · 21d ago↗ source
  • Oberland pours up to $400M into MeiraGTx eye gene therapies
    The funding deal is a vote of confidence in the sales potential of multiple prospects in late-stage development — one of which MeiraGTx recently reacquired from J&J.
    BioPharma Dive · 21d ago↗ source
  • Kailera says obesity pill succeeds in late-stage trial in China
    The drug spurred about 10% weight loss over 10 months, though that finding came alongside high rates of gastrointestinal side effects that “alarmed” one analyst.
    BioPharma Dive · 21d 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 · 21d 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 · 21d 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 · 21d 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 · 21d 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 · 21d ago↗ source
  • Vertex to acquire Crinetics in $10B foray into endocrine disease drugs
    Vertex claimed the two drugs in the deal could eventually bring in more than $5 billion annually. Still, the high price it paid stirred debate among analysts and investors.
    BioPharma Dive · 21d 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 · 21d ago↗ source
  • Vera Therapeutics wins FDA nod for closely watched kidney disease drug
    The clearance marks another step forward in treatment for IgA nephropathy and sets up a commercial battle with Otsuka, which brought a similar medication to market last year.
    BioPharma Dive · 21d 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 · 21d 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 · 22d 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 · 22d 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 · 22d 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 · 22d 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 · 22d 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 · 22d 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 · 22d ago↗ source
  • Gene editing developer Scribe plots an IPO
    The California drugmaker, which has collaborations in place with Biogen, Sanofi and Eli Lilly, could be the 14th biotech to go public in 2026.
    BioPharma Dive · 22d ago↗ source