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349 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 · 1h 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 · 3h agoNegative readoutNegative↗ source
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Psychiatry & CNS862
Ophthalmology494
Pain473
Endocrinology & Metabolism466
Infectious Disease444
  • Novartis shares tumble after late-stage failure of Avidity-acquired drug
    Novartis announced that its late-stage trial of a drug it acquired from Avidity did not meet its primary endpoints. The setback follows a recent disappointment in a heart disease study, adding pres…
    Endpoints · 2h agoNegative readoutNegative↗ source
  • Novartis reports Phase 3 pelacarsen trial fails to improve cardiovascular outcomes
    Novartis said its late-stage Phase 3 trial of the antisense drug pelacarsen did not show a benefit in reducing major cardiovascular events compared with placebo. The result adds to a recent string…
    Endpoints · 20h 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
  • Novo Nordisk halts two late-stage ziltivekimab heart trials after futility finding
    Novo Nordisk announced it has stopped work early on two additional late-stage clinical studies of its IL-6 inhibitor ziltivekimab, which was being evaluated for heart disease. The decision followe…
    Endpoints · 1d agoNegative readoutNegative↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 12h agoLayoffsNegative↗ 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
  • 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 approves Ionis’ Zanvastro as first disease-modifying therapy for Alexander disease
    The U.S. Food and Drug Administration has granted approval to Ionis Pharmaceuticals' antisense oligonucleotide Zanvastro, the first therapy that modifies disease progression for Alexander disease.…
    BioSpace · 4d agoApprovalPositive↗ 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
  • Novartis and BMS pause CAR‑T trials after patient deaths while Revolution Medicines gains early FDA approval for pancreatic cancer drug
    Novartis has placed several trials of its CAR‑T therapy rapcabtagene autoleucel on hold after three patients receiving the treatment died. Bristol Myers Squibb also voluntarily froze its autoimmun…
    BioSpace · 6d agoRegulatoryNeutral↗ source
  • BMS faces steep risk if milvexian trial fails, could spark mega-cap merger frenzy
    BMS is heading toward a readout for its oral FXIa inhibitor milvexian, a trial that analysts say could be pivotal for the company's future growth. The recent collapse of merger talks with AstraZen…
    BioSpace · 6d agoNegative readoutNegative↗ source
  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 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 · 5d agoNeutral↗ source
  • Roche partners with China's Simcere Zaiming on $1.5 billion T-cell engager for B-cell diseases
    Roche announced a licensing agreement with Simcere Zaiming, a subsidiary of China's Simcere Pharmaceutical Group, to develop a trispecific T-cell engager called SIM0660. The deal includes an upfro…
    BioSpace · 6d agoDealPositive↗ source