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  • 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
  • Yale and Harvard faculty question benefits of FDA's 'America First' user fee provisions
    Yale and Harvard medical school faculty have voiced concerns about the latest FDA user fee agreement, which includes a set of "America First" provisions. The provisions are designed to prioritize…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
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  • 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
  • Novartis stops ALS TREM2 stabilizer after Phase 2 miss, marking fourth trial setback in a month
    Novartis has halted development of its TREM2 stabilizer VHB937, also known as lifonebart, for amyotrophic lateral sclerosis after the drug failed to meet either the primary or secondary endpoints i…
    BioSpace · 1mo agoNegative readoutNegative↗ 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
  • Biopharma workers increasingly postpone retirement, poll shows 52% plan to stay longer
    Biopharma professionals are rethinking retirement, with a BioSpace LinkedIn poll indicating that 52% expect to retire later than originally planned. Overall, 63% of respondents said they have chang…
    BioSpace · 1mo agoNeutral↗ 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
  • 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
  • GSK to acquire Chimagen’s trispecific T-cell engager program in deal up to $750 million
    GSK announced it will acquire a preclinical trispecific T cell engager program from Chinese biotech Chimagen Biosciences in a transaction that could total up to $750 million. The agreement provide…
    BioSpace · 1mo agoDealPositive↗ source
  • Vera Therapeutics reports two-year data showing Trutakna stabilizes kidney function in IgA nephropathy, paving way for full FDA approval
    Vera Therapeutics announced that its recently approved drug Trutakna has produced encouraging two-year results in patients with IgA nephropathy, a chronic autoimmune kidney disease. The data indic…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • RegCell secures multi-million dollar Series A to advance Nobel-winning regulatory T-cell therapy
    RegCell, a biotech founded by Nobel laureate Shimon Sakaguchi, announced a new financing round to move its regulatory T-cell (Treg) program toward clinical testing. The company’s CEO Michael McCul…
    Endpoints · 1mo agoDealPositive↗ 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
  • FDA launches Operation TrialBlazer to accelerate early-stage drug trials and bring research back to the U.S.
    The FDA announced it is now accepting applications for Operation TrialBlazer, an expedited IND pilot program. The program pairs drug sponsors with qualified U.S. research institutions to cut the r…
    BioSpace · 1mo agoRegulatoryPositive↗ 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 launches expedited IND pilot program, integrating public feedback into qualification criteria
    The FDA announced that its long-awaited expedited investigational new drug (IND) pilot program has started accepting applications as of Tuesday. Agency leaders Karim Mikhail and Michael Davis, new…
    Endpoints · 1mo agoRegulatoryNeutral↗ source