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1,784 stories matching this filter · ← front page

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  • 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…
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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
  • Opinion: If Americans risk their lives fighting Ebola overseas, they deserve the right to come home
    Outbreak response is difficult enough without asking responders to wonder whether they will have access to the best available care if they become ill.
    STAT · 1mo ago↗ source
  • STAT+: Will Makary’s FDA voucher program survive?
    RevMed's cancer drug feels out of reach for some, SCOTUS preserves key generic drug pathway, and more biotech news
    STAT · 1mo ago↗ source
  • STAT+: Up and down the ladder: The latest comings and goings
    From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
    STAT · 1mo ago↗ source
  • Texas AG investigating energy drinks
    The limitations of private health insurance, the quiet collapse of America's research ethics watchdog and other Morning Rounds news
    STAT · 1mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about Roche accusing U.S. of ‘blackmail,’ a ruling on skinny labels, and more
    Drugmakers and patient groups asked the FDA to pause former commissioner Marty Markary's National Priority Voucher drug review program
    STAT · 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
  • Opinion: How living and practicing medicine abroad complicated my beliefs about universal health care systems
    “I believe deeply in universal health care. But universal care must also mean universal safety and accountability, not merely universal access.”
    STAT · 1mo ago↗ source
  • Tiny HHS office tasked with protecting research participants’ safety is running on fumes
    OHRP has experienced an unprecedented exodus of ethics expertise, raising concerns about its ability to effectively protect volunteers.
    STAT · 1mo ago↗ source
  • HHS confirms Americans with high-risk Ebola exposures will have access to experimental therapy
    Americans who have high-risk exposures to Ebola in the current outbreak in Central Africa will have access to an experimental antibody treatment.
    STAT · 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
  • 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 · 1mo ago↗ source
  • 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