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  • Senator Todd Young urges White House to appoint biotech leader amid rising Chinese innovation
    Senator Todd Young, chair of the National Security Commission on Emerging Biotechnology, told Fierce he is concerned about China’s expanding role in biopharma. The commission notes that Chinese co…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • Novartis pays $125 million to acquire Sironax’s brain-delivery platform
    Novartis has exercised an option to buy Sironax’s platform for delivering large molecules across the blood‑brain barrier, with a $125 million payment due at closing. The technology is intended to…
    Fierce Biotech · 1mo agoDealPositive↗ source
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  • Dementia should be a campaign issue, not a political insult, says expert
    Jason Karlawish, a professor at Penn and co‑director of the Penn Memory Center, argues that dementia deserves serious policy focus during the upcoming election. He notes that about 7.1 million Ame…
    STAT · 1mo agoNeutral↗ source
  • Experts urge more representative enrollment in clinical trials
    A panel of regulators and industry leaders gathered to discuss how clinical trials can better reflect the diversity of patient populations. The discussion included officials from the U.S. Food and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • GOP Bill Seeks to Tilt Medicare Advantage Study Toward Insurers
    Republicans on the House Ways and Means Committee advanced a bill that would direct the Medicare Payment Advisory Commission, MedPAC, to study Medicare Advantage spending in a way that favors insur…
    STAT · 1mo agoRegulatoryNegative↗ source
  • WHO sees declining Ebola transmission in DRC but warns months of work remain
    The World Health Organization’s director‑general said on Wednesday that transmission rates of Ebola are falling in most provinces of the Democratic Republic of the Congo, offering a reason for caut…
    STAT · 1mo agoPositive↗ source
  • Sen. Warren calls for release of Trump-era pharma pricing contracts amid accusations against RFK Jr.
    Sen. Warren has publicly demanded that the contracts governing drug pricing under the Trump administration be disclosed. She alleges that RFK Jr. is concealing these agreements, raising concerns ab…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA opens applications for pilot program to speed up first-in-human testing
    The U.S. Food and Drug Administration announced that it is now accepting applications for a pilot program designed to shorten the time required for drug developers to begin first‑in‑human clinical…
    STAT · 1mo agoRegulatoryPositive↗ source
  • 'Still a bull': Novo's CEO on honoring heritage and planning for the future amid corporate rebrand
    Novo CEO Mike Doustdar—tapped to breathe new life into the Danish drugmaker last year after losing GLP-1 marketing ground to chief rival Eli Lilly—isn’t one to make changes for the sake of change.
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • Senators probe nominee Chris Klomp’s influence on HHS health-policy and drug pricing
    Senators on the Finance and Energy committees held two days of hearings to examine the authority that Chris Klomp would have if confirmed as deputy secretary of HHS. Klomp, a senior adviser who se…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Democrats pledge to use oversight powers to push health-care reforms if they win Congress
    House Democrats say they will employ congressional oversight to advance a health-care overhaul should they gain control of the House or Senate. They intend to focus on health-care topics, includin…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Experts assess EU medical device and diagnostic regulations at RAPS Convergence 2026
    A panel of experts representing the European Commission, industry groups and notified bodies gathered in Charlotte, North Carolina during RAPS Convergence 2026. The group reviewed the current stat…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Professor uses his own thymic cancer journey to teach medical students about real-world oncology
    David Elkowitz, a professor of pathology and laboratory medicine at Hofstra/Northwell, writes about how his personal battle with thymic cancer shapes his teaching. He now brings his own case into…
    STAT · 1mo agoPositive↗ source
  • Saratoga Potato Chips recalls J. HIGGS Loaded Bacon & Cheddar chips over undeclared soy allergen
    Saratoga Potato Chips of Fort Wayne, Indiana announced a recall of two best‑if‑used‑by codes of its 7.75‑ounce J. HIGGS Loaded Bacon and Cheddar potato chips because the product may contain undecla…
    fda recalls · 1mo agoCRLNeutral↗ source
  • Vera Therapeutics' Trutakna shows kidney function stabilization and lower death risk in Phase 3 IgAN trial
    Vera Therapeutics reported that its drug Trutakna met its primary goals in a two‑year Phase 3 study of patients with IgA nephropathy. The therapy stabilized kidney function and lowered the risk of…
    STAT · 1mo agoPositive readoutPositive↗ source
  • GSK licenses Chimagen trispecific T-cell engager for up to $750 million, targeting phase-1 multiple myeloma study
    GSK has entered a licensing agreement with China’s Chimagen Biosciences that could be worth as much as $750 million. The deal will allow GSK to begin phase‑1 testing of a trispecific T‑cell engager…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Fourth measles death reported in Pennsylvania, all victims unvaccinated
    Pennsylvania health officials reported a fourth measles-associated death in the state, involving an 18-year-old from Mifflin County. The death was caused by acute disseminated encephalomyelitis, a…
    STAT · 1mo agoNegative↗ source
  • Medicare AI prior-authorization pilot plagued by rollout glitches, causing care delays
    Documents obtained through a Freedom of Information Act lawsuit reveal that the Medicare program using artificial intelligence for prior authorization was launched hastily and suffered numerous tec…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA approves Telix's Pixclara, first FET-PET imaging drug for glioma in the U.S.
    The U.S. Food and Drug Administration has granted approval to Telix Pharmaceuticals' Pixclara, a fluorine‑18 labeled amino acid PET tracer designed for imaging gliomas. This marks the first FDA‑cle…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Johnson & Johnson’s depression drug JNJ-5120 fails primary endpoint in phase 2 trial
    A phase 2 study of JNJ-5120, an M1 receptor antagonist developed by Johnson & Johnson with Contineum Therapeutics, did not meet its primary efficacy endpoint in patients with major depressive disor…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Sling Therapeutics raises $123M Series C to advance oral thyroid eye disease drug into Phase 3
    Sling Therapeutics announced a $123 million Series C financing round aimed at moving its oral therapy for thyroid eye disease into a late‑stage trial and eventual market launch. The company has be…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Medicare expands ACCESS pilot to cover more chronic conditions with outcome-based payments
    Medicare's ACCESS model, a pilot that pays technology providers for managing chronic diseases, is being broadened. Initially covering diabetes, hypertension, chronic musculoskeletal pain, depressi…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA opens pilot program to speed human testing of new drugs
    The Food and Drug Administration announced it is accepting applications for a pilot under Operation TrialBlazer aimed at reducing the time before drug candidates can start human trials. The initia…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA opens pilot to accelerate phase 1 trials with fast IND reviews
    The Food and Drug Administration announced a new pilot program aimed at speeding up early-stage clinical trials in the United States. The initiative pairs drug sponsors with qualified research inst…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • New documents expose flaws in Medicare’s rushed AI prior-authorization pilot
    New internal documents have highlighted serious shortcomings in Medicare’s recently launched AI-driven prior‑authorization pilot, which was rolled out faster than anticipated. The pilot, designed…
    STAT · 1mo agoRegulatoryNegative↗ source