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1,106 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 will…
    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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Endpoints · 1mo ago
↗ source
  • Pharma is betting big on PD-1/VEGF bispecifics. But are companies chasing the wrong target?
    While many drugmakers are focused on lung cancer, evidence shows the liver may be a better bet.
    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 announcemen…
    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 different…
    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 Fr…
    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 and…
    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 $216…
    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 Germa…
    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. T…
    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 Scal…
    Endpoints · 1mo ago↗ source
  • Alnylam, Inceptive ink AI deal potentially worth $2B
    The RNA-focused drugmaker says Inceptive's tools will help prioritize the best development options as well as speed up the research process.
    BioPharma Dive · 1mo ago↗ source
  • An ADC specialist sinks on safety concerns for blood cancer drug
    Shares for ADC Therapeutics fell more than 50% after a Phase 3 trial observed a death rate that at least one analyst believes “may be difficult to accept for physicians, patients and regulators.”
    BioPharma Dive · 1mo ago↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 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 through with it…
    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 cash…
    Endpoints · 1mo ago↗ source
  • A Spanish biotech banks $87M to make differentiated ADCs
    Ona Therapeutics, a Barcelona-based drugmaker, is developing next-generation drugs it says could help patients with advanced forms of breast and colorectal cancers.
    BioPharma Dive · 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 a coll…
    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 applica…
    Endpoints · 1mo ago↗ source