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  • FDA approves new treatments for persistent herpes and schizophrenia; Steris to acquire Xodus Medical for $2.1 billion
    The U.S. Food and Drug Administration has granted approvals for two new drugs, one targeting persistent herpes infections and another for the treatment of schizophrenia. The herpes indication addr…
    raps · 9d agoApprovalPositive↗ source
  • FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standards
    The U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
    raps · 9d agoRegulatoryNeutral↗ source
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  • Japan's PMDA Issues Guidance to Safeguard Participants in Generic Bioequivalence Trials
    The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released new guidance aimed at protecting healthy adult volunteers who take part in generic bioequivalence studies. The document…
    raps · 9d agoRegulatoryNeutral↗ source
  • Europe’s share of clinical trials falls 13.5% as Asia’s research footprint expands
    The latest data show a 13.5% drop in the number of clinical trials authorized in the EU and EEA compared with pre-pandemic levels. At the same time, Asian countries have increased their share of g…
    raps · 9d agoNeutral↗ source
  • Americans show higher trust in science than most countries, survey finds
    A new Wellcome Global Monitor survey of people in 140 countries found that 52% of Americans say they have a lot of trust in science, compared with just 26% globally. Only 40% of Americans reported…
    STAT · 10d agoNeutral↗ source
  • Half-century after IL-2 discovery, its impact on HIV, cancer and blood safety is highlighted
    Robert Gallo marks the 50-year anniversary of the 1976 paper that described interleukin-2, one of the first cytokines identified and essential for T-cell growth. He notes that IL-2 enabled the dis…
    STAT · 11d agoPositive↗ source
  • FDA flags safety concern after four deaths in schizophrenia drug trial
    The U.S. Food and Drug Administration issued a warning after four participants died while receiving an experimental treatment for schizophrenia in a clinical study. The agency described the observ…
    STAT · 11d agoRegulatoryNegative↗ source
  • Hospitals file second lawsuit to block Trump admin's 340B rebate pilot
    The American Hospital Association (AHA) has filed another lawsuit against the federal government, challenging a new version of the 340B drug discount program proposed by the Trump administration.…
    STAT · 11d agoRegulatoryNegative↗ source
  • Pharma gifts and payments to doctors linked to higher inappropriate prescribing, study finds
    A Cochrane review of dozens of prior studies found that gifts and payments from drug makers to physicians lead to more inappropriate prescribing and a higher total number of prescriptions, which li…
    STAT · 11d agoNegative↗ source
  • Proposed Census Overhaul Could Undermine Public Health Data, Experts Warn
    Federal officials are proposing three major revisions to the U.S. Census. The plan would drop questions on race, ethnicity and sexual orientation and would count only U.S. citizens, leaving out non…
    STAT · 11d agoRegulatoryNegative↗ source
  • Proposed US Census rule changes could distort health data, warns epidemiologist
    Nancy Krieger, a professor of social epidemiology at Harvard T.H. Chan School of Public Health, wrote an opinion piece warning that proposed changes to the U.S. decennial census could have severe p…
    STAT · 11d agoRegulatoryNegative↗ source
  • FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten generics
    The Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
    raps · 12d agoRegulatoryNeutral↗ source
  • Study finds rising patent thickets may slow generic drug competition
    A recent special communication in JAMA reports that the number of patents linked to FDA‑approved small‑molecule drugs has risen over the past 15 years. The increase is driven largely by non‑primary…
    raps · 12d agoNeutral↗ source
  • Humana tops 2027 Medicare Advantage star ratings as insurers face $13 billion in bonus payouts and legal challenges
    The Centers for Medicare & Medicaid Services released the 2027 star ratings for Medicare Advantage plans, with Humana emerging as the top‑scoring insurer. Plans that achieve at least four out of f…
    STAT · 11d agoRegulatoryNeutral↗ source
  • FDA issues early alert on Philips Lumify ultrasound system software and connection problems
    The FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a s…
    fda medwatch · 12d agoRegulatoryNegative↗ source
  • Biotech executive Steven Quay dropped from consideration for NIAID director role
    Steven Quay, a biotech executive known for promoting the lab‑leak theory, was reportedly in the running to lead the National Institute for Allergy and Infectious Diseases. A source familiar with t…
    STAT · 11d agoNeutral↗ source
  • Life Biosciences injects experimental cellular reprogramming drug into three glaucoma patients, reports no serious adverse events
    Life Biosciences provided an update on its early‑stage glaucoma study involving its experimental cellular reprogramming therapy. The company said three patients have each received a single intravi…
    STAT · 11d agoPositive readoutPositive↗ source
  • Researcher uses Reddit data to map post-Roe abortion access barriers
    Betsy Pleasants, a postdoctoral researcher at the Center for Women’s Health Research, began studying how the Covid‑19 pandemic affected abortion services while a graduate student at UC Berkeley. W…
    STAT · 11d agoNeutral↗ source
  • Q32 Bio appoints José Trevejo as chief medical officer, coming from Enveda Therapeutics
    STAT+ ran its regular "up and down the ladder" column highlighting recent personnel moves in the pharma sector. The feature invites readers to share hiring, promotion and departure news for broader…
    STAT · 11d agoNeutral↗ source
  • MAHA movement fades as midterms approach, lacking visibility and funding
    Health secretary Robert F. Kennedy Jr.'s Make America Healthy Again (MAHA) movement entered the political arena promising to rally an unlikely coalition of activists and deliver significant gains f…
    STAT · 11d agoNegative↗ source
  • Roche partners with Chinese biotech Defand Therapeutics to co-develop new medicines
    Roche announced a partnership with Chinese biotech startup Defand Therapeutics aimed at joint discovery of new drug candidates. Unlike the typical licensing deals where companies obtain rights to…
    STAT · 12d agoDealPositive↗ source
  • Argenx's Vyvgart fails to beat placebo in Phase 3 Sjögren's disease trial
    Argenx announced that its marketed antibody therapy Vyvgart did not show superiority over placebo in a Phase 3 study involving patients with Sjögren's disease, a chronic autoimmune condition. The…
    STAT · 12d agoNegative readoutNegative↗ source
  • Roche partners with China's Defand Therapeutics to discover molecular glue medicines
    Roche announced a collaboration with Chinese biotech Defand Therapeutics aimed at discovering new molecular glue medicines for oncology and immune‑mediated diseases. Unlike typical licensing deals…
    STAT · 12d agoDealPositive↗ source
  • CMS proposes changes to curb 340B drug discount program’s costly subsidies to safety-net hospitals
    Casey B. Mulligan, chief economist and chief regulatory officer at HHS, wrote an opinion piece outlining a major flaw in the 340B drug discount program. The program, created in 1992, gives steep di…
    STAT · 12d agoRegulatoryNegative↗ source
  • NIH funding uncertainty clouds US research, dampens biotech investor sentiment
    The latest episode of STAT’s “The Readout LOUD” podcast examined how the National Institutes of Health is allocating its budget and the growing uncertainty surrounding future funding. Hosts Elaine…
    STAT · 12d agoNegative↗ source