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1,029 stories matching this filter · ← front page

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  • FDA's acting director of cell and gene therapies to leave position
    Vijay Kumar is leaving his role as acting director of CBER's Office of Therapeutic Products and will soon consider options both inside and outside the FDA, he told Endpoints News on Tuesday. Kuma…
    Endpoints · 26d ago↗ source
  • Sarepta's FDA decision date; Flare gets Anna Protopapas as CEO
    Plus news about Deerfield, InflaRx, Praxis, Nuvectis, Pyxis Oncology, Vistagen, Arcutis Biotherapeutics and Nxera. 🔎 FDA to decide on future of Sarepta exon-skipping drugs by end of February: Th…
    Endpoints · 26d ago↗ source
  • Beeline ups its Series A round for immune drug work
    <figure><div><img src="https://imgproxy.divecdn.com/4FSYxYVR65mzzE0lNMMPQjdujTL0_B50-03lC1bSrS8/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS8yWEtHQ0JZLmpwZw==.webp"/></div></f…
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BioPharma Dive · 26d ago
↗ source
  • Top FDA gene and cell therapy regulator to step down
    <figure><div><img src="https://imgproxy.divecdn.com/ZralPibwV2FS7gfl92V7anvyG-GCm_2yJ_lZgP4LM4k/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS8yRENKUkI1LmpwZw==.webp"/></div></f…
    BioPharma Dive · 26d ago↗ source
  • Nominations are open for the 2026 Endpoints 11 awards
    There’s never been a higher bar for innovation than right now. Almost any promising molecule quickly has a horde of copycats. Development costs keep rising. Investors are leaning on seemingly saf…
    Endpoints · 26d ago↗ source
  • How mental health chatbots are trained on therapy sessions
    As people increasingly turn to AI for everyday tasks, companionship and emotional assurance, virtual mental health companies once wary of AI are racing to build out their own chatbots to stay compe…
    Endpoints · 26d ago↗ source
  • Unicycive gets second CRL for kidney drug as manufacturing woes continue
    Unicycive Therapeutics’ chronic kidney disease drug was rejected by the FDA for a second time over persistent issues at a third-party contract manufacturer. The company’s phosphate binder drug ox…
    Endpoints · 26d ago↗ source
  • Sanofi’s Lumizyme successor passes Phase 3 test in babies with Pompe disease
    Sanofi said its enzyme replacement therapy succeeded in a registrational trial in a severe form of Pompe disease, paving the way for a key label expansion in the US. The French pharma is looking…
    Endpoints · 27d ago↗ source
  • Beeline adds $126M to Bain-backed immunology pipeline from Bristol Myers
    Bristol Myers Squibb spinout Beeline Medicines is getting extra love from its existing backers and some of its management team. Bain Capital, the Canada Pension Plan Investment Board, and Bristol…
    Endpoints · 27d ago↗ source
  • BeOne’s Brukinsa succeeds in frontline mantle cell lymphoma study
    BeOne Medicines said its BTK inhibitor Brukinsa cut the risk of disease progression or death by 43% compared to chemoimmunotherapy when used as a first option for mantle cell lymphoma patients. T…
    Endpoints · 27d ago↗ source
  • House China panel probes Bristol Myers, Pfizer on use of trial sites
    A congressional committee has opened an inquiry into Bristol Myers Squibb and Pfizer's use of clinical trial sites in China, including facilities that the committee's chairman said are affiliated w…
    Endpoints · 27d ago↗ source
  • NEJM retracts pivotal data for Amgen's Tavneos
    Pivotal data for Amgen’s Tavneos have been retracted from the New England Journal of Medicine, creating another obstacle for the beleaguered autoimmune drug. Two academic authors requested the re…
    Endpoints · 27d ago↗ source
  • John Reed on J&J’s R&D model, oncology deals and pipeline expansion potential
    John Reed has overseen the pipelines of three of the largest drugmakers since leaving Southern California's Sanford Burnham medical research institute 13 years ago, giving him unique insight into h…
    Endpoints · 27d ago↗ source
  • EU lobby urges member states to improve Europe’s life sciences sector
    More than 200 biopharma investors and firms have signed an open letter calling for European governments to improve Europe’s life sciences sector. The Friday letter was addressed to EU member stat…
    Endpoints · 27d ago↗ source
  • Zymeworks CEO on why the Theravance deal is value for money
    On the face of it, nearly $1 billion seems like a lot to spend on a biotech like Theravance. The company was clearly running out of steam, having twice downsized and been hit with repeated ...
    Endpoints · 27d ago↗ source
  • BioCryst ends internal discovery programs, will close Alabama research facility
    BioCryst Pharmaceuticals is winding down its own drug discovery work, saying that it plans to look for future drug programs externally. The company announced a plan to discontinue its internal di…
    Endpoints · 27d ago↗ source
  • Evommune's lead drug fails in chronic hives, stock sinks
    Evommune's shares {$EVMN} fell more than 30% on Monday morning after the biotech reported its first major trial readout since going public last year. In chronic spontaneous urticaria, a skin cond…
    Endpoints · 27d ago↗ source
  • Biotech SPAC deal gets it to Nasdaq; AstraZeneca Phase 3 win in bone disease
    Plus news about Alebund Pharmaceuticals, Regenxbio and Neuphoria Therapeutics. 💸 A SPAC!: Talawar Therapeutics will land on the Nasdaq via a combination with blank-check company JATT II Acquisit…
    Endpoints · 27d ago↗ source
  • Post-Hoc: China deals are pharma’s new tax inversions
    About a decade ago, when I had just started covering pharma, one of the biggest stories was tax inversions. For those who don’t remember, tax inversions were a form of M&A in which a US ...
    Endpoints · 27d ago↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    <figure><div><img src="https://imgproxy.divecdn.com/adiJN9GDP_sdBKAPLoO1u858OLmoo_2c7bk4eved-BY/g:nowe:919:1/c:1869:1055/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlc…
    BioPharma Dive · 27d ago↗ source
  • Ipsen to buy blood cancer company Kartos Therapeutics for $450M upfront
    Ipsen is earmarking up to $1.75 billion to take Kartos Therapeutics and its MDM2 protein-targeting drug candidate that it in-licensed from Amgen back in 2016. Ipsen will pay $450 million upfront ...
    Endpoints · 28d ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    <p>The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to…
    BioPharma Dive · 28d ago↗ source
  • FDA accepts Replimune filing; Merck KGaA drops $11B on life sciences services
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 1mo ago↗ source
  • At BIO, tension over China biotech deal regulation looms
    <figure><div><img src="https://imgproxy.divecdn.com/QMMgdLWmV9_RV75ozi_JOVMqLcnMq3yXkrVCs0nJ7_U/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMTgyOTQ2OTI4LmpwZ…
    BioPharma Dive · 1mo ago↗ source
  • Alkermes’ incoming CEO has a plan to outplay Lilly and Takeda
    <p>Blair Jackson says the next 12 months may be the most important in Alkermes’ history, as the brain drugmaker races to join an “orexin” market that analysts see as a multibillio…
    BioPharma Dive · 1mo ago↗ source