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  • ADA panel still reviewing expulsions from June conference, further actions possible
    The American Diabetes Association released top‑line findings on Sept. 1 from an internal panel tasked with reviewing the June 5 expulsion of five members at its New Orleans conference. The full re…
    STAT · 6h agoNegative↗ source
  • STAT readers weigh in on MD vs DO training, AI accountability and surrogacy in medicine
    STAT’s First Opinion platform invites letters that respond to its essays, and a recent submission addresses several hot topics in health care. The writer acknowledges the bias that osteopathic gra…
    STAT · 1d agoNeutral↗ source
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Novartis' experimental heart drug pelacarsen fails pivotal Phase 3 trial
Novartis announced that its experimental cardiovascular therapy, pelacarsen, did not meet its primary endpoints in the Phase 3 HORIZON trial. The study compared the drug to placebo and found no red…
STAT · 2d agoNegative readoutNegative↗ source
  • Ionis secures FDA approval for zilganersen, a first treatment for Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its antisense drug zilganersen for the treatment of Alexander disease, an ultra‑rare neurodegenerative disord…
    Fierce Biotech · 2d agoApprovalPositive↗ source
  • Menarini to launch Gan & Lee’s GLP-1 drug bofanglutide across Europe in $771 M partnership
    Italian firm Menarini Group has entered a licensing agreement with Chinese insulin producer Gan & Lee Pharmaceuticals to bring the GLP-1 compound bofanglutide to Europe. The deal includes an upfro…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Novartis' Lp(a) drug pelacarsen fails to cut heart attack or stroke risk in phase 3 trial
    Novartis, in partnership with Ionis, completed the phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide designed to lower lipoprotein(a) levels. The study enrolled more than 8,30…
    Fierce Biotech · 2d agoNegative readoutNegative↗ source
  • Experts say Angelman syndrome drug failure leaves hope for similar antisense therapies
    Ultragenyx announced that its late-stage trial of an experimental Angelman syndrome drug did not meet its primary endpoints, marking a setback for the rare-disease community. Researchers such as M…
    STAT · 2d agoNegative readoutNeutral↗ source
  • Bristol Myers Squibb pauses autoimmune CAR‑T trials after life‑threatening side effects
    Bristol Myers Squibb announced in early June that it is pausing its CAR‑T therapy trials targeting autoimmune diseases after the trials reported life‑threatening side effects. The company informed…
    STAT · 2d agoRegulatoryNegative↗ source
  • Mass General Brigham drops Dana-Farber from its Medicare Advantage network starting Oct 1
    Mass General Brigham announced that its Medicare Advantage plan will no longer include Dana-Farber Cancer Institute in its provider network beginning October 1, following a recent split between the…
    STAT · 2d agoRegulatoryNegative↗ source
  • FDA revisits botanical drug pathway amid ongoing challenges for clozapine and pig kidney research
    The Food and Drug Administration is taking another look at the regulatory pathway for botanical drugs, signaling renewed interest in how plant‑derived therapies can be evaluated and approved. At t…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Disabled workers face higher risk of losing health insurance, report highlights systemic gaps
    The Morning Rounds newsletter reports that disabled employees are more likely to lose their health coverage, underscoring a systemic vulnerability in the U.S. health insurance landscape. The artic…
    STAT · 2d agoNegative↗ source
  • Lindsay Clancy case highlights risks of fragmented US health care system
    In the months leading up to the tragic deaths of her three children, Lindsay Clancy sought help for worsening mental health from multiple clinicians and two hospitals. She received 13 different med…
    STAT · 2d agoNegative↗ source
  • FDA lifts clozapine monitoring requirements, easing use for children with schizophrenia
    The Food and Drug Administration on Feb. 24, 2025 eliminated the long‑standing monitoring program that has governed clozapine for more than three decades. The change removes the extensive paperwork…
    STAT · 2d agoRegulatoryNeutral↗ source
  • CDC-Pennsylvania dispute over measles death counts fuels drama amid rising cases
    Former CDC officials warn that a clash with Pennsylvania over how measles deaths are counted is creating unnecessary drama while cases surge. They explain that states normally follow a standardize…
    STAT · 2d agoRegulatoryNegative↗ source
  • AbbVie’s bispecific T‑cell engager etentamig shows positive phase 3 results in relapsed/refractory multiple myeloma
    AbbVie reported that its bispecific T‑cell engager etentamig met its primary goals in the phase 3 Cervino trial for patients with relapsed or refractory multiple myeloma. The trial demonstrated hi…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • Gene-edited pig kidneys enable patients to go months without dialysis before receiving human transplants
    Doctors at eGenesis reported that two patients who received genetically engineered pig kidneys were later able to receive human donor kidneys after a period on dialysis. The transition was not seam…
    STAT · 3d agoPositive↗ source
  • Ionis secures FDA approval for Zanvastro, first disease-modifying therapy for rare Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Zanvastro, marking the first disease-modifying treatment for Alexander disease, a rare and often fatal neurol…
    STAT · 3d agoApprovalPositive↗ source
  • Pfizer sells Seagen-derived ADC to Medicus Pharma for $12 million upfront, potential $1 billion milestones
    Pfizer has transferred rights to an antibody‑drug conjugate it acquired in its Seagen purchase to Medicus Pharma. Medicus will pay $12 million upfront and $15 million a year later, and Pfizer coul…
    Fierce Biotech · 3d agoDealPositive↗ source
  • GSK agrees $1.3 billion deal with Hutchmed for early-stage KRAS-EGFR cancer candidate
    GSK will pay $110 million upfront to Hutchmed as part of a deal that could reach $1.295 billion, giving GSK worldwide rights to develop and commercialize a preclinical oncology asset. The asset, i…
    Fierce Biotech · 4d agoDealPositive↗ source
  • Ultragenyx's Angelman gene therapy fails Phase 3, company to cut expenses
    Ultragenyx reported that its late‑stage Aspire trial of apazunersen in Angelman syndrome did not meet its primary or secondary endpoints. The primary goal of improving the Bayley‑4 cognitive raw sc…
    Fierce Biotech · 4d agoNegative readoutNegative↗ source
  • Seattle researchers unveil $95 million AI biology initiative to map nature’s design rules
    Seattle scientists have announced a new $95 million effort that uses artificial intelligence to decode the design principles of biological molecules. The project, led by Nobel laureate David Baker,…
    STAT · 3d agoDealNeutral↗ source
  • Ultragenyx gene therapy for Angelman syndrome fails Phase 3 trial, company to cut expenses
    An experimental gene therapy targeting Angelman syndrome did not meet its primary endpoint in a Phase 3 study, according to Ultragenyx. The trial showed no difference between the therapy, GTX-102,…
    STAT · 3d agoNegative readoutNegative↗ source
  • Abivax remains independent despite intense acquisition speculation
    Biotech merger activity is at record levels, yet the French company Abivax, which is developing the ulcerative colitis drug obefazimod, has not been bought. Rumors have floated about a potential $…
    STAT · 3d agoDealNegative↗ source
  • Overdose deaths fall sharply in US and abroad, report links decline to naloxone and harm-reduction measures
    A new report highlights a sudden drop in drug overdose deaths after years of consistently high numbers in the United States. The data show that U.S. deaths fell 27% in 2024 and preliminary figures…
    STAT · 4d agoNeutral↗ source
  • FDA’s Biologics Branch Scores Wins Against Unproven Stem Cell Clinics, Says Expert
    Professor Paul Knoepfler, a cell‑biology professor at UC Davis, writes that the FDA’s biologics division has recently taken concrete steps to curb the proliferation of unproven stem‑cell clinics in…
    STAT · 3d agoRegulatoryPositive↗ source