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799 stories matching this filter · ← front page

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  • 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,
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Hematology6
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Infectious Disease4
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Dermatology2
Endpoints · 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
  • Lilly, Boehringer retrench in Germany on proposed health spending cuts
    Backlash is brewing against a sweeping overhaul of Germany’s health insurance system as Eli Lilly and Boehringer Ingelheim slash investment in the country. The drugmakers' cuts come after the Ger…
    Endpoints · 1mo ago↗ source
  • Supreme Court sides with Hikma in 'skinny label' case
    The Supreme Court unanimously sided with Hikma Pharmaceuticals and its “skinny label” version of a prescription-strength fish oil pill in a case that was closely watched by the generics industry.…
    Endpoints · 1mo ago↗ source
  • Novo Holdings backs European fund; Alnylam sends second obesity drug into clinic
    Plus news about IMU Biosciences, Autobahn and Jade Biosciences. 💸 Novo Holdings invests in Europe-focused fund: The investment manager of the Novo Nordisk Foundation's fortunes is backing the Sc…
    Endpoints · 1mo ago↗ source
  • Parabilis Medicines charts $413M IPO to back peptide pipeline
    Parabilis Medicines, the peptide biotech led by former Johnson & Johnson R&D head Mathai Mammen, is seeking more than $400 million in its Nasdaq debut. If the drug developer follows throu…
    Endpoints · 1mo ago↗ source
  • ADC Therapeutics' confirmatory data for Zynlonta muddied by death rates
    ADC Therapeutics’ bid to secure full approval for Zynlonta in relapsed or refractory diffuse large B-cell lymphoma has been complicated by death rates in its confirmatory trial. The company said ...
    Endpoints · 1mo ago↗ source
  • ADC biotech Ona Therapeutics secures $86.6M in Series B raise
    Barcelona-based Ona Therapeutics has raised $86.6 million in a Series B round to advance two ADC candidates into the clinic. CEO Valerie Vanhooren told Endpoints News in an interview that the cas…
    Endpoints · 1mo ago↗ source
  • Alnylam to pay $30M upfront to AI startup Inceptive in RNA R&D deal
    Alnylam Pharmaceuticals announced its first discovery-focused AI deal Wednesday, tapping a Silicon Valley biotech startup to see if AI can boost its R&D efforts. Alnylam and Inceptive signed…
    Endpoints · 1mo ago↗ source
  • Bristol Myers turns focus to AI costs after broad rollout to workers
    PALO ALTO, CA — After giving artificial intelligence tools to thousands of employees, Bristol Myers Squibb is now working to get a handle on the costs of the technology and where it’s actually crea…
    Endpoints · 1mo ago↗ source
  • Axsome pushes back generic entry for narcolepsy drug until 2040
    Axsome Therapeutics has successfully delayed generic competition for its narcolepsy drug Sunosi until 2040. The company announced on Wednesday that it has reached a settlement with the last appli…
    Endpoints · 1mo ago↗ source
  • FDA guides pharma on explaining unapproved drugs to payors
    Biopharma companies preparing to launch the next practice-changing blockbusters want payors to know what's coming before they ultimately land an FDA approval. The trick is to do that without stretc…
    Endpoints · 1mo ago↗ source
  • What it will take for more employer GLP-1 coverage
    Last week, Eli Lilly proclaimed that its weight loss shot and pill are now “covered for millions of Americans,” now that all three major pharmacy benefit managers have put the ...
    Endpoints · 1mo ago↗ source
  • Regeneron doubles down on CytomX after other pharmas walked away
    After losing a couple of pharma alliances in recent quarters, CytomX Therapeutics is getting a major lift from a key collaborator. Regeneron is doubling down on its partnership with the Bay Area…
    Endpoints · 1mo ago↗ source
  • Mineralys makes money moves before looming hypertension approval
    Mineralys Therapeutics first drew attention in 2021 with a bold bet on a new type of hypertension drug called lorundrostat. It came with a tiny $1 million upfront fee to the medicine's originator,…
    Endpoints · 1mo ago↗ source
  • Lilly strikes Ascidian deal worth up to $1.9B for RNA editing in kidney diseases
    Last month, Ascidian Therapeutics presented the first data suggesting a new way to fix broken genes may be safe in people. Now Eli Lilly has struck a deal with the startup. Ascidian’s ...
    Endpoints · 1mo ago↗ source