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  • 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
  • STAT+: Drug companies, patient groups urge FDA to pause commissioner’s voucher program
    The White House has used the program to reward companies that help its political goals.
    STAT · 1mo ago↗ source
  • What RevMed’s pancreatic cancer drug meant for one patient
    Why did a presentation on Revolution Medicines' pancreatic cancer drug get a standing ovation? Why did biotech stocks perform so badly this week? Find out on "The Readout LOUD."
    STAT
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· 1mo ago
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  • STAT+: Otsuka kidney drug slowed loss of function, but less than expected, in late-stage trial
    Otsuka’s Voyxact slowed the loss of kidney function after one year in patients with a chronic autoimmune kidney disease, but the benefit was less than expected.
    STAT · 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
  • STAT+: Supreme Court backs generic drugmaker in ‘skinny labeling’ case
    The Supreme Court unanimously ruled that Hikma Pharmaceutical did not infringe patents held by Amarin in a decision with implications for lawsuits over so-called skinny labels.
    STAT · 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
  • STAT+: For pancreatic cancer patients, an exciting drug can feel out of reach
    For pancreatic cancer patients, the surge in interest for an exciting new drug is leaving them fearful about when they might get the treatment or if there will be enough…
    STAT · 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
  • STAT+: RFK Jr.’s second year: Vacancies, not vaccines
    Assessing the health secretary's biggest challenges, and a look at new rules that inject politics into the NIH.
    STAT · 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
  • STAT+: AI titans push Congress for DNA safeguards
    Inceptive Nucleics and Alnylam's partnership, why Grail's "failed" trial still matters, and other biotech news from The Readout
    STAT · 1mo ago↗ source
  • STAT+: Utah Medical Board scolded for going rogue with AI criticism
    In this edition of STAT Health Tech: An update on the Utah pilot that uses a chatbot to renew drug prescriptions, AI scribes for patients, and more.
    STAT · 1mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about fewer pharma investments in Germany, growing U.S. layoffs, and more
    Eli Lilly is halving its originally planned investment in the production of weight loss syringes in Germany in response to a cost-cutting law
    STAT · 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
  • Scientists uncover a new hiding spot for HIV
    An Ebola update, Trump to strip job protections of NIH officials, and more health news from Morning Rounds
    STAT · 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
  • STAT+: Does Revolution Medicines’ pancreatic cancer drug have even greater potential?
    Revolution Medicines' pancreatic cancer drug has not yet been approved — and already talk has shifted to how (and when) its use might be expanded.
    STAT · 1mo ago↗ source
  • Male puberty is understudied — but when it starts may predict long-term health risks
    Due to a significant gender gap, far less is known about the health risks of early or late puberty onset among boys than girls.
    STAT · 1mo ago↗ source