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  • Nurix to work with Roche on BTK degrader in pact worth up to $2.3B
    Roche is set to pay Nurix Therapeutics $700 million upfront to collaborate on a BTK degrader for B cell malignancies, with broader plans in immunology and neurology. The deal could be ...
    Endpoints · 1mo ago↗ source
  • Innovation alone is no longer enough in biopharma
    <p>In biopharma, the next edge may come from the systems that turn discovery into scale.</p>
    BioPharma Dive · 1mo ago↗ source
  • Precision under pressure: Logistic solutions for nuclear medicine scalability
    <p>Racing the clock: How precision logistics deliver life-saving nuclear medicine.</p>
    BioPharma Dive · 1mo ago↗ source
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  • #ADA26: 19% of Phase 3 patients quit Boehringer obesity shot over side effects
    Boehringer Ingelheim’s obesity asset survodutide, which it licensed from Zealand Pharma, has shown high rates of discontinuations in its Phase 3 obesity study. In April, data from the SYNCHRONIZE…
    Endpoints · 1mo ago↗ source
  • #ADA26: Pfizer's monthly shot shows effect on obesity, diabetes
    The long-acting GLP-1 shot that was the centerpiece of Pfizer’s acquisition of Metsera last year looks effective in patients with both obesity and diabetes, according to data presented Saturday.…
    Endpoints · 1mo ago↗ source
  • #ADA26: Roche to start Phase 2 petrelintide, enicepatide combo trial this year
    Roche says it has one obesity drug with a potential best-in-class safety profile, and another with a similar shot at leading in efficacy. Combining them could produce a highly successful product if…
    Endpoints · 1mo ago↗ source
  • Lawmakers propose China restrictions; #ASCO26 recap; and more
    Welcome back to Endpoints Weekly! We had a small team in Chicago last weekend at this year’s ASCO conference. You’ll find a recap of their coverage below, including more details on Revolution Medic…
    Endpoints · 1mo ago↗ source
  • #ADA26: Roche's incretin shot works in mid-stage trial in type 1 diabetes
    A daily incretin shot being developed by Roche has shown promise in type 1 diabetes — the form that is not generally believed to be directly treatable by GLP-1-based drugs. According to Phase 2 d…
    Endpoints · 1mo ago↗ source
  • In Washington, biotech's China hawks are winning the conversation
    Biopharma industry lobby groups working to keep the pipeline open for plentiful, lower-cost drugs coming from China have awakened to the fact that they face a vocal opposition and a growing set of…
    Endpoints · 1mo ago↗ source
  • Industry seeks more clarity on commissioner's voucher program
    The pharma industry and rare disease advocates voiced concerns about the transparency and fairness of the Commissioner's National Priority Voucher pilot program. The program faces an uncertain fu…
    Endpoints · 1mo ago↗ source
  • House committee directs FDA to speed up IND sign-off process
    The House Appropriations Committee told the FDA to reform the way it signs off on new clinical trials, reflecting a broader effort to ensure the US keeps pace with China and other nations in develo…
    Endpoints · 1mo ago↗ source
  • Study data convince Lundbeck to push new migraine drug forward
    <figure><div><img src="https://imgproxy.divecdn.com/ceSX_zK_xrNDSLemnaIYCXioPqyDYQ7AtvyGxwG6poo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xOTE5NjIzOTQ2XzEua…
    BioPharma Dive · 1mo ago↗ source
  • Generic drugmakers gain key victory in ‘skinny label’ patent case
    <figure><div><img src="https://imgproxy.divecdn.com/ziTZorQlSmji768zIR1l1ktFtiVk9NxBSdR62q8K0IA/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMjA4NzE3Njg0LmpwZ…
    BioPharma Dive · 1mo ago↗ source
  • Innovent declares Phase 3 success for ADC that attracted huge Takeda deal
    Innovent Biologics' ADC candidate has passed a Phase 3 trial in advanced stomach cancer and is under priority review in China, but details of the success are still under wraps. The Phase 3 win wi…
    Endpoints · 1mo ago↗ source
  • Fulcrum lays off majority of staff; Seres extends runway into 2027
    👥 Fulcrum Therapeutics reduced to a shell: The biotech is letting go 48 of its 57 full-time employees, according to an SEC filing. The step comes after Fulcrum said
    Endpoints · 1mo ago↗ source
  • Novo vet Uli Stilz settles in at Flagship; Revolution Medicines welcomes commercial exec
    Uli Stilz has been trotting the globe this year to talk about the future of biotech and bridge an increasingly international industry. He was in Japan this week,
    Endpoints · 1mo ago↗ source
  • Pharma is betting big on PD-1/VEGF bispecifics. But are companies chasing the wrong target?
    <figure><div><img src="https://imgproxy.divecdn.com/xbHcBuJpB2jn4XdBnacn9EL1qH4IPhhgp3V92WERlvI/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9TY3JlZW5zaG90XzIwMjYtMDYtMDNfYXRfM…
    BioPharma Dive · 1mo ago↗ source
  • Otsuka touts new IgAN evidence as it seeks full approval for Voyxact
    Otsuka Pharmaceutical reported new evidence on Thursday that it thinks will help support a full approval for its monoclonal antibody Voyxact in a chronic autoimmune disease that affects the kidneys…
    Endpoints · 1mo ago↗ source
  • Acting FDA chief isn't interested in permanent role
    Acting FDA Commissioner Kyle Diamantas isn't interested in keeping the job and the search for a permanent replacement is progressing, according to a source familiar with the process. An announcem…
    Endpoints · 1mo ago↗ source
  • Acting FDA commissioner pledges to prevent political interference in rare disease meeting
    Executives from 15 rare disease-focused nonprofits met on Wednesday with acting FDA Commissioner Kyle Diamantas and senior staff. In the meeting, Diamantas made it clear he's headed in a differen…
    Endpoints · 1mo ago↗ source
  • Dimension seeks up to $750M for third life sciences fund after string of success
    Dimension Capital, an investment firm focused on the convergence of machine learning and life sciences, is raising its third batch of capital and seeking up to $750 million. The New York and San…
    Endpoints · 1mo ago↗ source
  • Elevance talks 'practical' AI
    In the spirit of keeping up with how health insurers are using AI, I chatted with Elevance Health’s Ratnakar Lavu this week. The chief digital information officer has held roles at Kohl’s, Nike a…
    Endpoints · 1mo ago↗ source
  • Mammalian hair, roof leaks: Novo Nordisk's site in Indiana under FDA scrutiny once again
    Novo Nordisk’s troubled factory in Indiana continues to face contamination issues, with a re-inspection in April finding mammalian hair in finished drugs and water leaks that risk product sterility…
    Endpoints · 1mo ago↗ source
  • Mammalian hair, roof leaks: Novo Nordisk's site in Indiana under FDA scrutiny once again
    Novo Nordisk’s troubled factory in Indiana that it got from Catalent continues to face contamination issues, with a re-inspection in April finding mammalian hair in finished drugs and water leaks t…
    Endpoints · 1mo ago↗ source
  • Hikma to funnel $267M to Ohio; Cingulate gets CRL for ADHD drug
    Plus, news about West Pharmaceutical, Stallergenes Greer and Curium: 🏭 Hikma’s US expansion: The generic drugmaker is investing $267 million in Ohio. Its existing factory in Columbus will get $2…
    Endpoints · 1mo ago↗ source