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298 stories matching this filter · ← front page

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  • Roivant's experimental pulmonary hypertension drug meets Phase 2 goals
    Roivant announced that its experimental drug mosliciguat achieved the primary endpoint in a 16‑week Phase 2 trial for pulmonary hypertension, a serious lung condition. The study showed a 56% reduc…
    STAT · 2h agoPositive readoutPositive↗ source
  • Novartis' DM1 drug del-desiran misses primary endpoint in Phase 3 HARBOR trial
    Novartis announced that its experimental therapy del-desiran did not improve muscle function in a pivotal Phase 3 study for myotonic dystrophy type 1 (DM1). The trial, called HARBOR, evaluated the…
    STAT · 4h agoNegative readoutNegative↗ source
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  • Novartis' del-desiran fails primary endpoint in phase 3 Harbor trial for myotonic dystrophy type 1
    Novartis announced that its experimental therapy del-desiran did not meet the primary endpoint in the phase 3 Harbor trial, which evaluated improvement in video hand opening time in patients with m…
    Fierce Biotech · 8h agoNegative readoutNegative↗ source
  • Novo Nordisk abandons two phase 3 trials of ziltivekimab, dimming blockbuster hopes
    Novo Nordisk announced it is terminating two late‑stage phase 3 studies of its IL‑6 ligand antibody ziltivekimab. The Hermes and Athena trials enrolled about 4,900 and 673 patients with heart fail…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Novo Nordisk halts two cardiovascular trials of inflammation-targeting drug ziltivekimab
    Novo Nordisk announced it is halting the HERMES and ATHENA cardiovascular trials of its experimental drug ziltivekimab, which was intended to lower inflammation to improve heart health. A data mon…
    STAT · 1d agoNegative readoutNegative↗ source
  • Roivant’s inhaled pulmonary hypertension drug mosliciguat shows strong Phase 2 results
    Roivant invested $14 million in Bayer's inhaled soluble guanylate cyclase activator mosliciguat after a $294 million biobucks agreement in 2024, and promptly advanced the candidate into a Phase 2 s…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • 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 · 1d agoNegative↗ source
  • 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 · 3d 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 · 4d agoApprovalPositive↗ 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 · 3d agoNegative readoutNegative↗ 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 · 3d agoNegative↗ 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 · 4d agoPositive↗ source
  • FDA alerts hospitals to purge cassette fault in Abiomed Impella controllers
    The FDA issued an Early Alert after identifying a problem with the purge cassette recognition in Abiomed’s Automated Impella Controllers, which could cause prolonged delays in mechanical circulator…
    fda medwatch · 5d agoRegulatoryNegative↗ 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 · 5d agoDealNegative↗ source
  • New cardiovascular guidelines released for tactical athletes such as EMTs, firefighters and police
    The American College of Cardiology and the American Heart Association issued new cardiovascular guidance aimed at clinicians who treat "tactical athletes," a term that includes emergency responders…
    STAT · 4d agoRegulatoryPositive↗ source
  • Fauci warns of public "selective amnesia" on Covid, hints at upcoming book as STAT newsletter covers Trump drug pricing deals
    STAT's twice‑weekly D.C. Diagnosis newsletter continues to blend health policy analysis with behind‑the‑scenes commentary, offering readers insight into current political debates. In a recent inte…
    STAT · 4d agoNeutral↗ source
  • HHS reverses stance on disability lawsuit amid reports of falling overdose deaths and AI device access
    The Department of Health and Human Services has changed its position on a pending disability lawsuit, signaling a shift in its legal strategy. Data released this year show a sharp decline in U.S.…
    STAT · 4d agoRegulatoryNeutral↗ source
  • Former doula turned OB‑GYN calls for better understanding between the two professions
    Debra Eluobaju, a maternal‑fetal medicine fellow who previously worked as a doula, reflects on the gap between doulas and obstetricians. She argues that many conflicts in maternity care stem from s…
    STAT · 5d agoNeutral↗ source
  • Medline expands recall of reprocessed electrophysiology and ultrasound catheters due to contamination risk
    Medline Industries has issued an expanded recall that adds new lots of reprocessed electrophysiology and ultrasound catheters after the FDA identified possible residual particulates in the devices.…
    fda medwatch · 6d agoCRLNegative↗ source
  • ARPA-H grants funding to biotech firms developing custom RNA therapies amid broader biotech updates
    ARPA-H is providing grants to several biotech companies to develop custom RNA therapeutics, aiming to accelerate personalized medicine. Roche has licensed a tri‑specific antibody, adding a new mod…
    STAT · 5d agoNeutral↗ source
  • ADA internal review refutes censorship and police involvement allegations after conference ejections
    The American Diabetes Association (ADA) completed an internal review following the removal of several members from its scientific sessions in New Orleans. The review concluded that there was no cen…
    STAT · 6d agoNeutral↗ source
  • Novartis reports positive multiple sclerosis results with its BTK inhibitor
    Novartis announced that its BTK inhibitor has shown a positive outcome in a multiple sclerosis study, marking a notable advance for the company in this therapeutic area. The result highlights the…
    STAT · 6d agoPositive readoutPositive↗ source
  • Boston Scientific stops sales of Imager II catheters after tip defect linked to two injuries
    Boston Scientific issued a letter on August 24 advising customers to remove all Imager II angiographic catheters from use or sale after discovering a manufacturing problem. The problem involves re…
    Fierce Biotech · 7d agoCRLNegative↗ source
  • Trump administration announces new drug pricing pledges, but details remain undisclosed
    On Monday the Trump administration said a second group of pharmaceutical companies had agreed to cut drug prices to levels similar to those in other countries. The companies involved have pledged t…
    STAT · 6d agoDealNegative↗ source
  • Study finds Paxlovid ineffective for treating long Covid
    A recent study reported that the antiviral Paxlovid did not provide measurable benefit for patients suffering from long Covid symptoms. Researchers observed no significant improvement compared with…
    STAT · 6d agoNegative readoutNegative↗ source