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  • 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 · 13d 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 · 14d agoRegulatoryNegative↗ source
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  • Long-term unemployment pushes many biopharma professionals to quit job searches
    A recent BioSpace LinkedIn poll shows that about one-quarter of biopharma workers who have been unemployed for six months or more have stopped looking for new positions, and a similar share are con…
    BioSpace · 14d agoNegative↗ source
  • Scaling delivery is key for CAR T therapies to succeed in autoimmune diseases
    Biopharma companies are exploring CAR T cell therapies as a potential cure for autoimmune disorders, a market that could be twice the size of oncology. While current treatments manage symptoms, the…
    BioSpace · 14d agoNeutral↗ 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 · 14d 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 · 13d agoRegulatoryNeutral↗ source
  • Generate Bio drops as data accidentally leaked ahead of European conference
    Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
    BioSpace · 13d 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 · 14d 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 · 14d 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 · 14d agoNegative↗ source
  • Experts discuss hurdles and prospects for the first approved Fragile X therapy
    In a recent episode of BioSpace's "Denatured" podcast, Hilary Rosselot of the National Fragile X Foundation and Jordi Fàbrega, co‑founder and CEO of CONNECTA Therapeutics, talked about the current…
    BioSpace · 14d agoNeutral↗ source
  • Biopharma hiring gaps: experts cite four key mismatches between companies and candidates
    Recruiting specialists highlighted persistent disconnects between biopharma employers and job seekers, noting that misaligned expectations can slow hiring and discourage talent. One major issue st…
    BioSpace · 14d agoNeutral↗ 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 · 14d 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 · 13d 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 · 14d 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 · 13d 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 · 14d agoApprovalPositive↗ source
  • FDA grants early approval to RevMed's pancreatic cancer drug Rasonque
    FDA granted early approval to Revolution Medicines' daraxonrasib, now named Rasonque, for pancreatic adenocarcinoma, arriving 6.5 months before the FDA deadline. The oral RAS inhibitor demonstrate…
    BioSpace · 14d 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 · 14d agoApprovalPositive↗ source
  • Summit Therapeutics and Akeso report Phase 3 survival benefit for ivonescimab in Chinese biliary tract cancer
    Summit Therapeutics and its Chinese partner Akeso said their bispecific antibody ivonescimab combined with chemotherapy improved overall survival for patients with first-line biliary tract cancer i…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • Jazz's Ziihera receives FDA approval for first-line treatment of HER2-positive gastroesophageal cancer
    The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals' bispecific antibody Ziihera for use as a first‑line therapy in patients with unresectable locally advanced or metastatic gas…
    BioSpace · 15d agoApprovalPositive↗ source
  • Biohaven sells rights to its lead epilepsy drug opakalim to SK Biopharma for up to $795 million
    Biohaven announced it will transfer the rights to its most advanced experimental therapy for focal epilepsy, known as opakalim, to South Korean company SK Biopharma. The agreement could bring as m…
    BioPharma Dive · 14d agoDealNeutral↗ source
  • Experimental drugs to lower Lp(a) move toward market, promising billions in potential sales
    High levels of lipoprotein(a), or Lp(a), are a genetic risk factor for heart disease that affects roughly one in five people and currently has no approved therapy. Several drugmakers are moving ex…
    STAT · 15d agoPositive↗ source
  • Spyre shares plunge as rheumatoid arthritis trial of SPY072 falls short of internal target
    Spyre Therapeutics reported that its antibody SPY072 did not meet the company’s internal criteria in a mid‑stage rheumatoid arthritis trial, despite showing some activity. The placebo‑controlled s…
    BioPharma Dive · 14d agoNegative readoutNegative↗ source
  • Vitruvias Therapeutics shuts down after recalling potentially superpotent thyroid tablets
    Vitruvias Therapeutics announced it is ceasing operations and has voluntarily recalled a batch of its generic thyroid tablets because the product may be superpotent. The recall covers 3,655 units…
    BioSpace · 14d agoCRLNegative↗ source