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  • FDA rejects Hengrui-Elevar liver cancer drug combo for third time
    For the third time in about two years, the FDA has cited manufacturing deficiencies in rejecting a drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics intended to treat th…
    Endpoints · 17d ago↗ source
  • CDER adds 100+ new employees in a quarter for first time since late 2024
    The FDA's drug center hired more new employees than it lost in a quarter for the first time since the Trump administration gutted the agency's ranks in April 2025. The FDA's
    Endpoints · 17d ago↗ source
  • US biotechs turn secretive as they fear competition from rising Chinese industry
    Janine Sengstack believes she may have found the next big breakthrough in diabetes and obesity. Her company, Junevity, has searched through hundreds of genes to discover ones that, when repressed,…
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Hematology6
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Endpoints · 17d ago
↗ source
  • GSK, Hansoh ADC extends survival in lung cancer study
    <figure><div><img src="https://imgproxy.divecdn.com/mDk-h3NLB8udDPFuDlI7IPou1i9tJKJYucQXUnhK9vA/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMTc3MzEzMjc4LmpwZ…
    BioPharma Dive · 17d ago↗ source
  • German lawmakers pass cost-saving bill that drugmakers say will drive them out
    Germany’s federal parliament has voted to pass a bill designed to cut domestic healthcare spending that could negatively impact drugmakers, drawing sharp criticism from the country’s main pharmaceu…
    Endpoints · 17d ago↗ source
  • Hansoh meets Phase 3 SCLC goal; FDA approves Sanofi on-body injector
    Plus, news about Huntington's, Fate Therapeutics and Bausch + Lomb. 🇨🇳 Hansoh touts Phase 3 success for GSK-partnered ADC: The program, called risvutatug rezetecan or Ris-Rez, met its primary e…
    Endpoints · 17d ago↗ source
  • ARPA-H puts $160M into bespoke drug therapies; Biohaven switches up scientific leadership
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 17d ago↗ source
  • The data that led Cellular Intelligence to pick up Novo's Parkinson's stem cell therapy
    MONTREAL — After Novo Nordisk closed its cell therapy unit, Cellular Intelligence contracted neurologist and drug developer Nuno Mendonça to conduct due diligence on the Danish pharma’s Parkinson’s…
    Endpoints · 18d ago↗ source
  • Pfizer appoints obesity discovery head; AI startup Xaira makes leadership adjustments
    → Danna Breen has been promoted to head of obesity discovery at Pfizer, according to a LinkedIn post. Breen succeeds Kendra Bence and gets this opportunity after nearly 14 years with ...
    Endpoints · 18d ago↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    <p>The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal…
    BioPharma Dive · 18d ago↗ source
  • ARPA-H bookmarks $160M for custom gene editing treatments. Is it enough?
    After an infant last year was saved from a deadly disease thanks to a bespoke gene editing therapy that fixed an incredibly rare mutation in his DNA, the US government is hoping ...
    Endpoints · 18d ago↗ source
  • HHS advances plan to pay out Covid-19 vaccine injury claims
    A newly proposed HHS rule would establish a compensation mechanism for people who claim they were injured by Covid-19 vaccines, as a key panel that oversees broader vaccine injury payments remains…
    Endpoints · 18d ago↗ source
  • Roche ends work on tominersen after decade of trials, as well as early-stage Huntington’s asset
    After more than a decade of work and plenty of ups and downs, Roche has dropped its Huntington’s disease drug tominersen. The decision comes after tominersen did no better than placebo in a Phase…
    Endpoints · 18d ago↗ source
  • UK price watchdog recommends against Amgen's Lumakras in lung cancer
    The UK’s drug pricing watchdog said government reimbursement of Amgen’s lung cancer drug Lumakras should be cut off for new patients. In draft guidance released on Thursday, the National Institut…
    Endpoints · 18d ago↗ source
  • FDA criticizes Lundbeck for webpages on migraine treatment Vyepti
    The FDA has chastised Lundbeck Seattle Biopharmaceuticals for two promotional webpages that made allegedly inflated claims regarding the efficacy of its migraine drug. In an untitled letter sent…
    Endpoints · 18d ago↗ source
  • GSK ends brain drug alliance with Alector
    <figure><div><img src="https://imgproxy.divecdn.com/mDk-h3NLB8udDPFuDlI7IPou1i9tJKJYucQXUnhK9vA/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMTc3MzEzMjc4LmpwZ…
    BioPharma Dive · 18d ago↗ source
  • FDA quietly stops releasing CRLs
    The FDA has paused its public release of pharma rejection letters as the agency seeks to avoid litigation around releasing the often sensitive information. The pause follows a law firm in April
    Endpoints · 18d ago↗ source
  • The biggest health tech stories of 2026 — so far
    We’re more than halfway through 2026, and it’s been an eventful year. Here are the five biggest developments we noticed in the first six months. Major AI companies are coming for healthcare.
    Endpoints · 18d ago↗ source
  • Ipsen succeeds in migraine trials; Tarsus buys iRenix for $75M upfront
    Plus news on Alchemab, Scipher and Forte. 💉 Ipsen’s Dysport aces Phase 3 migraine trials: The biotech’s injectable neurotoxin met the primary endpoint of reducing monthly migraine days in two ...
    Endpoints · 18d ago↗ source
  • Eli Lilly dominates first-half biotech acquisitions, with no sign of slowing down
    Riding on its trillion-dollar heft and successes in treating obesity, Eli Lilly has now become a force in one area where it hasn’t historically been the main player: M&A. The Indianapolis-bas…
    Endpoints · 18d ago↗ source
  • Catalent to divest UK site; Rottendorf, Evonik announce manufacturing builds
    Plus, news about RoslinCT, Novo Nordisk and more. 🇬🇧 Catalent to sell UK site to Codis: The CDMO is set to take Catalent’s oral solid dose factory in Nottingham, with ...
    Endpoints · 18d ago↗ source
  • HHS plan to speed drug research won’t remove ‘self-inflicted’ delays
    <figure><div><img src="https://imgproxy.divecdn.com/CBRbv7ysPGDg2gR4-a3jhbQNYceSmw-Eq03sjZFRhY4/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMTk2ODIwNDM5LmpwZ…
    BioPharma Dive · 18d ago↗ source
  • AstraZeneca, Ionis drug fails big heart disease study in major setback
    <figure><div><img src="https://imgproxy.divecdn.com/BEaA7RlZhiBVZ8rfvBq1gV4dfZ4BC5WOow-17uS8d2o/g:nowe:0:100/c:8192:4628/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlc…
    BioPharma Dive · 18d ago↗ source
  • GSK walks away from Alector pact as immuno-neurology bet fizzles
    After two high-profile trial failures over the past year, GSK is breaking off a deal that features $700 million upfront that it signed with Alector for neurodegenerative disease treatments. GSK’s…
    Endpoints · 19d ago↗ source
  • Updated: AstraZeneca sinks on unexpected heart drug trial failure
    AstraZeneca’s shares dropped in early trading Thursday after a heart disease treatment it is developing with Ionis Pharmaceuticals surprisingly failed in a late-stage trial. The companies had aim…
    Endpoints · 19d ago↗ source