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3,106 stories matching this filter · ← front page

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  • FDA says it will maintain Makary’s focus on clinical trials, rare diseases and China despite leadership exits
    The Food and Drug Administration announced that, even after the recent resignations of Commissioner Marty Makary and the heads of its drug and biologics centers, it will keep pursuing the policy ag…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • FDA greenlights Colorado's plan to import prescription drugs from Canada to lower costs
    The FDA announced Monday that Colorado will be allowed to bring in certain prescription medicines from Canada, aiming to reduce drug prices for state residents. This decision makes Colorado the se…
    STAT · 2mo agoApprovalPositive↗ source
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  • FDA greenlights Colorado plan to import prescription drugs from Canada to lower prices
    FDA announced Monday that Colorado will be allowed to import certain prescription medicines from Canada, making it the second state to receive such authorization after Florida. The move is intende…
    STAT · 2mo agoApprovalPositive↗ source
  • Takeda releases additional Phase 3 data to bolster its orexin program amid new competition
    Takeda announced new results from its two Phase 3 trials of an orexin‑targeting therapy. The data are intended to demonstrate the drug’s efficacy and safety, reinforcing Takeda’s claim of market‑l…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Elicio Therapeutics’ KRAS pancreatic cancer vaccine fails in Phase 2, stock drops sharply
    Elicio Therapeutics reported that its KRAS‑targeted vaccine for pancreatic cancer did not improve patient outcomes in a mid‑stage (Phase 2) trial. The study results were released in a company state…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Gan & Lee reports positive Phase 3 obesity trial results; J&J shares multiple myeloma data
    Gan & Lee Pharmaceuticals, a China‑based insulin specialist, announced topline results from its Phase 3 obesity trial, indicating a successful outcome. The company said the study met its primary e…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • European trial registry shows under half of studies missing timely results, analysis says
    A new analysis of a major European clinical trial database found that fewer than half of the studies reported results within the legally required timeframe, and only 42% provided complete data. Th…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Covid vaccine linked to 24% drop in overall cardiac events, study of 1 million veterans shows
    A new analysis of more than one million U.S. veterans indicates that receiving a Covid‑19 vaccine is associated with a substantial reduction in heart‑related problems. Researchers observed a roughl…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Neumora Therapeutics halts lead depression drug after two more Phase 3 failures, plans 35% staff cuts
    Neumora Therapeutics announced that its lead depression candidate will be discontinued after it did not meet primary endpoints in two additional Phase 3 trials. The company said the data were consi…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Lilly reports early positive results for new JAK2 inhibitor in hard-to-treat myelofibrosis
    Lilly has incorporated a JAK2‑targeting drug originally discovered by Ajax Therapeutics after its recent acquisition. The experimental pill is intended for patients with myelofibrosis, a difficult‑…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Sanofi’s Tzield approved amid review dispute as Bicillin shortage hampers syphilis treatment
    An Arizona woman pregnant with syphilis could not receive timely treatment because of a worsening shortage of Bicillin, the injectable penicillin made by Pfizer. The shortage has raised concerns ab…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • US sees 800% rise in congenital syphilis births amid penicillin shortage, officials warn of preventable "never event"
    The article notes a dramatic surge in congenital syphilis cases in the United States, with births affected rising about 800% between 2012 and 2024. This increase is described as a "never event" bec…
    STAT · 2mo agoNegative↗ source
  • Celiac disease faces new therapeutic possibilities as companies target underlying inflammation
    Celiac disease affects roughly one in every hundred people worldwide, imposing a daily burden that goes far beyond dietary restrictions. Currently, patients have no approved medicines and must rel…
    BioPharma Dive · 2mo agoPositive↗ source
  • HMNC Brain Health raises $50M Series B to advance two depression drugs
    HMNC Brain Health announced it has closed a $50 million Series B financing round. The capital will be used to move two depression drug candidates into mid-stage clinical trials. The round was led…
    Endpoints · 2mo agoDealNeutral↗ source
  • Pfizer fails to provide emergency penicillin donations as Trump administration seeks policy change to curb drugmaker price avoidance
    Pfizer has not complied with a request from state health agencies to donate emergency penicillin, a measure intended to act as a backstop against congenital syphilis. The shortfall underscores ong…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Lilly showcases Jaypirca combination data in CLL at EHA26, debuting results from Ajax acquisition
    Eli Lilly highlighted new blood‑cancer data at the European Hematology Association meeting in Stockholm. The company presented early clinical results for its Jaypirca therapy combined with the stan…
    Endpoints · 2mo agoNeutral↗ source
  • Medicaid fraud crackdown threatens home care for disabled, risking loss of essential services
    States are adopting a Medicaid fraud enforcement strategy modeled on the Trump administration, tightening regulations and cutting funding that many disability advocates say will strain the home‑car…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Strategic steps for moving sterile injectables from lab to clinical trials
    The article, sponsored by Vetter, discusses how drug owners of sterile injectable candidates face a key question when a molecule is ready for first‑in‑human studies: how fast can a clinical batch b…
    BioPharma Dive · 2mo agoPositive↗ source
  • South Asian American families often keep autism diagnoses hidden, delaying care
    Child and adolescent psychiatrist Ritu Goel points out that the CDC now estimates autism affects about one in 31 U.S. children, a rise from earlier figures. She observes that many South Asian Ameri…
    STAT · 2mo agoNegative↗ source
  • Six Biopharma Leaders Drive LGBTQ+ Inclusion Amid Rising Anti-LGBTQ Legislation
    Six executives are spearheading initiatives to improve LGBTQ+ inclusion across the biopharmaceutical sector. Their work focuses on creating supportive policies, training programs, and community out…
    Endpoints · 2mo agoNeutral↗ source
  • Pediatrician urges rigorous trials for AI tools used with children
    Dr. Dua Hassan, a pediatrician at Boston Children’s Hospital, writes an opinion piece about the growing use of artificial-intelligence applications in child care. She describes a typical office vi…
    STAT · 2mo agoNeutral↗ source
  • California law bans four harmful food additives, part of legislator Jesse Gabriel's push against ultra-processed foods
    California Assemblymember Jesse Gabriel has become a prominent figure in state food policy, championing measures aimed at reducing the health risks of ultra-processed foods. In 2023 he introduced…
    STAT · 2mo agoRegulatoryPositive↗ source
  • FDA approves Sanofi's teplizumab for children with stage 3 type 1 diabetes
    The FDA announced approval of teplizumab, a Sanofi developed therapy, for children aged 8 and older who have stage 3 type 1 diabetes. The decision came through the agency’s accelerated review path…
    STAT · 2mo agoApprovalPositive↗ source
  • WHO chief warns of worsening Ebola outbreak in DRC and Uganda after on-site visit
    The World Health Organization's director‑general said he is "really worried" after returning from a second trip to the Ebola‑affected regions of the Democratic Republic of the Congo and Uganda. He…
    STAT · 2mo agoNegative↗ source
  • Biopharma launches nominations for 2025 pay report and highlights Parabilis record IPO
    Endpoints Weekly announced the start of nominations for its eighth annual Women in Biopharma report, aiming to feature 20 distinguished women across science, leadership, and entrepreneurship. The…
    Endpoints · 2mo agoDealNeutral↗ source