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4,377 stories matching this filter · ← front page

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  • 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 · 2mo 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 · 2mo agoNegative readoutNeutral↗ source
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Psychiatry & CNS1204
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Pain775
Nephrology759
  • NeuShen Therapeutics raises over $80 million to advance three brain-health drug candidates
    NeuShen Therapeutics, a biotech with operations in Shanghai and Boston, announced it has closed a Series B financing round of more than $80 million. The capital will be used to move three clinical…
    Endpoints · 2mo agoDealPositive↗ 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 · 2mo agoRegulatoryNegative↗ source
  • Menarini secures European rights to Chinese GLP-1 obesity drug
    Menarini Group, a large family‑owned pharmaceutical company in Italy, has obtained the European commercial rights to a GLP‑1 agonist developed by China’s Gan & Lee. The agreement gives Menarini a…
    Endpoints · 2mo agoDealPositive↗ source
  • Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies
    Industry stakeholders have asked the U.S. Food and Drug Administration to expand the scope of its recent draft guidance on scientifically valid prior knowledge for gene therapies that involve genom…
    raps · 2mo agoRegulatoryNeutral↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoNegative↗ source
  • Thiel-backed Lindus Therapeutics sells CRO division and shifts focus to acquiring drug assets
    Lindus Therapeutics, a transatlantic startup backed by Peter Thiel, announced the sale of its contract research organization (CRO) arm. The company, previously positioning itself as an “anti‑CRO,”…
    Endpoints · 2mo agoDealNeutral↗ 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 · 2mo 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 · 2mo agoRegulatoryNegative↗ source
  • Foods Alive recalls organic moringa leaf powder over possible Salmonella contamination
    Foods Alive Inc. of Angola, Indiana announced a recall of its 8‑ounce organic moringa leaf powder because of a potential Salmonella contamination. The product was shipped nationwide between Jan 27…
    fda recalls · 2mo agoCRLNeutral↗ source
  • Akeso and Summit report ivonescimab meets overall survival endpoint in Phase 3 lung cancer trial
    Akeso and its partner Summit said the Phase 3 trial of ivonescimab, a PD-1xVEGF bispecific antibody, has met its overall survival endpoint in a selected group of lung cancer patients. The announcem…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • AbbVie reports 60% reduction in progression risk for myeloma drug etentamig in Phase 3 trial
    AbbVie announced results from a Phase 3 study of its T cell engager etentamig in patients with multiple myeloma. The trial demonstrated a 60% relative reduction in the risk of disease progression…
    Endpoints · 2mo agoPositive readoutPositive↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoDealPositive↗ source
  • GSK licenses Hutchmed's KRAS-EGFR antibody-drug conjugate for $110 million upfront
    GSK announced it will pay $110 million upfront to obtain a license for a KRAS-EGFR antibody-drug conjugate developed by Chinese biopharma Hutchmed. The agreement also includes potential milestone p…
    Endpoints · 2mo 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 · 2mo 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 · 2mo agoNegative readoutNegative↗ source
  • Merck's dealmaker warns of increased M&A activity as Keytruda patent expires
    Merck's chief M&A officer says the company expects a surge in deal flow as the patent for its flagship immunotherapy, Keytruda, approaches expiration. The leadership has been pursuing acquisitions…
    Endpoints · 2mo agoDealNeutral↗ 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 · 2mo agoDealNeutral↗ source