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  • Revolution Medicines’ pancreatic cancer drug Rasonque priced at $39,800 a month, analysts predict blockbuster sales after swift FDA approval
    Revolution Medicines announced that its new pancreatic cancer therapy, Rasonque, received FDA approval in a rapid review process. The drug is priced at $39,800 for a 30-day supply, which translate…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Moderna raises $2 billion after Phase 3 success of its algorithm-driven personalized cancer vaccine with Merck
    Moderna announced a $2 billion convertible debt financing, a move that follows the Phase 3 success of its personalized cancer vaccine developed with Merck. The vaccine relies on software that scan…
    STAT · 2mo agoPositive readoutPositive
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  • FDA approves Revolution Medicines' first genetic-targeted therapy for advanced pancreatic cancer
    The U.S. Food and Drug Administration has granted approval for a new treatment developed by Revolution Medicines aimed at patients with advanced pancreatic cancer. The therapy is designed to extend…
    STAT · 2mo agoApprovalPositive↗ source
  • Moderna and Merck report late-stage success for personalized mRNA cancer vaccine
    Moderna and Merck announced that their personalized cancer vaccine achieved its primary goals in a late-stage clinical trial, sparking enthusiasm across the biotech community. The experimental the…
    STAT · 2mo agoPositive readoutPositive↗ source
  • AstraZeneca and Amgen report positive Phase 3 results for Tezspire in eosinophilic esophagitis
    AstraZeneca and Amgen announced that their joint drug Tezspire met primary and secondary endpoints in a late-stage Phase 3 trial for eosinophilic esophagitis. The antibody targets TSLP and had pre…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Hospitals Mobilize to Challenge $1 Trillion Medicaid Funding Cuts
    Hospital leaders are reacting to a law that will cut nearly $1 trillion in Medicaid funding over the next ten years, prompting a rapid re‑evaluation of their financial models. Lobbyists and execut…
    STAT · 2mo agoRegulatoryNegative↗ source
  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 2mo agoApprovalPositive↗ source
  • Senator Cassidy's report blames FDA for lax oversight of abortion pill manufacturers
    Senator Bill Cassidy released a report accusing the Food and Drug Administration of failing to tighten restrictions on the abortion pill mifepristone and of lacking transparency in its oversight.…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Alnylam’s heart drug outlook dimmed as rival eplontersen fails at ESC Congress
    The European Society of Cardiology Congress in Munich is a focal point for Alnylam Pharmaceuticals as it seeks clarity on the future of its two ATTR-CM programs. Data presented by AstraZeneca and…
    STAT · 2mo agoNegative readoutNegative↗ source
  • FDA approves Roivant's brepocitinib for rare autoimmune disease dermatomyositis
    On Thursday the U.S. Food and Drug Administration gave its nod to a new therapy from Roivant Sciences and its subsidiary Priovant. The oral medication, brepocitinib, will be sold under the brand na…
    STAT · 2mo agoApprovalPositive↗ source
  • FDA grants emergency use authorization for generic Bimectin injection to prevent screwworm in cattle
    The U.S. Food and Drug Administration announced an Emergency Use Authorization for the generic ivermectin product Bimectin injection, allowing its use to prevent New World screwworm infestations in…
    fda press · 2mo agoRegulatoryPositive↗ source
  • Outer Bio unveils skin‑tissue platform that keeps samples alive for a month, creating terabytes of data for skincare research
    Outer Bio, a new biotech founded by Michael Polansky, has emerged from stealth to offer a skin‑focused platform that maintains harvested human skin tissue alive for about a month. The company says…
    BioPharma Dive · 2mo agoPositive↗ source
  • Hospitals Prepare Lobbying Effort to Counter $1 Trillion Health Care Funding Cuts
    Hospitals are gearing up to lobby Congress after a projected $1 trillion reduction in health‑care spending, which was part of recent tax‑cut legislation. Hospital leaders say they will seek higher…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Proposed Biotech Investment National Security Act may protect US firms but contains loophole aiding Chinese competition
    A bipartisan bill called the Biotech Investment National Security Act (BINSA) has been introduced in Congress to expand federal oversight of biotechnology activities, from drug development to biolo…
    STAT · 2mo agoRegulatoryNegative↗ source
  • DEA moves on kratom substances as FDA greenlights new pancreatic drug
    The Drug Enforcement Administration is taking new steps concerning substances associated with kratom, signaling a shift in how the agency handles the plant-derived compounds. In a separate develop…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • CMS to host launch event for ACCESS, its new Medicare chronic care pilot
    CMS announced it will hold a launch event for ACCESS, a pilot program aimed at chronic care management for Medicare beneficiaries. The pilot is intended to test new care coordination models and pa…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • FDA review highlights expanding role of manufacturing process models in drug applications
    The FDA released a review outlining how manufacturers can incorporate process modeling into their regulatory submissions. Process models are described as a growing scientific area and are being us…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Reddit reveals menopause symptoms often misdiagnosed, urging researchers to listen
    A University of Maryland researcher examined discussions on Reddit where women described perimenopause and menopause experiences that were frequently dismissed or misdiagnosed by clinicians. The on…
    STAT · 2mo agoNeutral↗ source
  • Louisiana directs 20% of opioid settlement funds to sheriffs, who spend millions on police equipment
    KFF Health News investigated how Louisiana sheriffs used their share of opioid settlement money. The state allocated 20% of the settlement payouts to the 64 elected sheriffs, the largest law‑enfor…
    STAT · 2mo agoNegative↗ source
  • MHRA revises guidance on periodic safety update reports for UK products
    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update to its pharmacovigilance procedures guidance. The revision focuses on the preparation and submission of periodic…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Former Stanford president posts emails to counter fraud claims in new book
    Former Stanford president Marc Tessier-Lavigne has posted a more than 3,000-word response on his lab website, including emails with former colleagues, to dispute claims that he fabricated research…
    STAT · 2mo agoNegative↗ source
  • FDA considers new deputy commissioner roles as Trump prepares to announce additional MFN drug pricing agreements
    The Food and Drug Administration is evaluating the establishment of new deputy commissioner positions to support its expanding portfolio of responsibilities. The proposal reflects ongoing efforts…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Documents show RFK Jr. sought to study Samoa’s MMR vaccines despite claiming his 2019 visit was unrelated to vaccines
    Health secretary Robert F. Kennedy Jr. told lawmakers that his 2019 trip to Samoa had nothing to do with vaccines. New documents obtained by the Associated Press and The Guardian include a letter…
    STAT · 2mo agoRegulatoryNegative↗ source
  • FDA grants rapid approval to Revolution Medicines' pancreatic cancer drug Rasonque
    FDA approved Revolution Medicines' pancreatic cancer therapy Rasonque, just over a month after submission using a priority review voucher. The drug, formerly known as daraxonrasib, is for patients…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • FDA approves Rasonque, first therapy targeting genetic cause of advanced pancreatic cancer
    The U.S. Food and Drug Administration has granted approval to Rasonque, a drug from Revolution Medicines, for patients with advanced pancreatic cancer. The medicine, whose generic name is daraxonra…
    STAT · 2mo agoApprovalPositive↗ source