Biotech & Medicine
185 articles RSS
China's NMPA Approves Satri-Cel, the World's First CAR-T Therapy for a Solid Tumor, in Advanced Gastric Cancer
CARsgen's Claudin18.2-directed CAR-T satri-cel won Chinese approval for pretreated gastric cancer, becoming the first CAR-T cleared for any solid tumor.
Pfizer's Sigvotatug Vedotin Misses Overall Survival Goal in Phase 3 Lung Cancer Trial, Salvaging a Signal in Second-Line Patients
Pfizer's integrin beta-6 ADC failed to beat docetaxel on overall survival across the full SigVie-002 population, but showed a stronger trend in the two-thirds of patients with one prior line of therapy.
Merck's Tulisokibart Becomes First Anti-TL1A Antibody to Hit Phase 3 Remission Endpoint in Ulcerative Colitis
Merck says its TL1A antibody tulisokibart met the primary and key secondary endpoints in the Phase 3 ATLAS-UC induction study, a first for the drug class.
Humacyte's Bioengineered Blood Vessel Beats the Standard AV Fistula in Phase 3 Dialysis Trial, Adding 91 Catheter-Free Days for Women
An interim analysis of Humacyte's V012 Phase 3 trial found its acellular tissue engineered vessel gave women on dialysis 220 catheter-free days versus 129 for an AV fistula.
Dual-Target Parkinson's Gene Therapy BBM-P002 Clears Phase 1 Safety Bar With 12-Month Motor Gains in Nature Medicine
A Shanghai-built AAV gene therapy delivering two dopamine-synthesis genes to the putamen was safe in 10 patients, with motor improvements at one year.
Bepirovirsen Delivers a Functional Cure in About One in Five Chronic Hepatitis B Patients in Phase 3 Trials
GSK's antisense drug bepirovirsen cleared chronic HBV in 20% and 19% of patients across two Phase 3 trials, versus none on placebo, the NEJM reports.
Cogent's Bezuclastinib-Sunitinib Combo Nearly Doubles Progression-Free Survival in Second-Line GIST, the First Positive Phase 3 in Two Decades
Cogent's bezuclastinib plus sunitinib reached 16.5-month median PFS versus 9.2 months in second-line GIST, with FDA Priority Review and a November 30 PDUFA date.
Selinexor Plus Ruxolitinib Shrinks Spleens but Misses Its Symptom Goal in Phase 3 SENTRY, With an Early Survival Signal in Myelofibrosis
The SENTRY trial of selinexor plus ruxolitinib met its spleen-volume endpoint and missed its symptom endpoint, with an immature overall survival signal favoring the combination.
MoonLake's Sonelokimab Holds 67% Response at Week 52 in Phase 3 Hidradenitis Suppurativa Trials, Setting Up a September FDA Filing
Full Week 52 data from MoonLake's VELA program show sustained response rates for the IL-17 Nanobody, nine months after one of its two pivotal trials missed its primary endpoint.
Relacorilant Becomes the First Glucocorticoid Receptor Antagonist Approved for Ovarian Cancer as Full ROSELLA Data Land in The Lancet
Corcept's relacorilant plus nab-paclitaxel cut the risk of death 35% in platinum-resistant ovarian cancer, raising median survival to 16 months from 11.9, with the phase 3 ROSELLA results published in The Lancet.
FDA Approves Utebzi, the First Oral Carbapenem Antibiotic, for Complicated Urinary Tract Infections
GSK and Spero's tebipenem pivoxil becomes the first oral carbapenem cleared in the US, four years after an FDA rejection.
Intellia's In Vivo CRISPR Therapy Cuts Hereditary Angioedema Attacks 87% in Phase 3 HAELO Trial Published in NEJM
Lonvoguran ziclumeran met its primary endpoint with an 87% reduction in monthly attacks, the first Phase 3 win for an in vivo CRISPR therapy.