Clinical Trial News

Nicolas Girard discusses Teliso-V's promising efficacy and manageable safety profile in c-Met–overexpressing, EGFR wild-type, nonsquamous NSCLC, with improved QOL and cancer-related symptoms like cough and chest pain, as reported in the LUMINOSITY trial. Patient-reported outcomes (PROs) show Teliso-V's benefits align with clinical data, though peripheral neuropathy requires monitoring.

Regeneron Pharmaceuticals and Sanofi receive FDA approval for Dupixent as add-on treatment for adolescents with CRSwNP, based on Phase 3 trials showing improvements in nasal congestion, polyp size, and sense of smell, and reduced need for corticosteroids or surgery.

Loyal's phase two trial of Loy-002 aims to extend dogs' lives; Robin Jackson's 11-year-old dog Reilly shows significant improvements, leading her to believe he received the actual drug. Dr. Alison Barulich notes unexplained improvements in blood lipids. The drug targets metabolic health regulation to potentially extend life quality and length.

FDA approves Biotronik's stylet-driven lead and delivery catheter system for left bundle branch area pacing, based on BIO-CONDUCT trial results showing high implant success and low complications.

ICMR signs agreements for first-in-human clinical trials of four new molecules.

FIBRONEER™-IPF trial met primary endpoint: absolute change in Forced Vital Capacity at week 52. Boehringer Ingelheim to submit nerandomilast for IPF treatment to FDA and other Health Authorities worldwide.

InspireMD submits FDA premarket approval for CGuard Prime carotid stent system, based on C-GUARDIANS trial data showing 1.95% major adverse event rate at 12 months, aiming for U.S. approval for stroke prevention.

The FDA approved Apple's sleep apnea detection feature, announced at the iPhone 16 launch. The feature, using a 'breathing disturbances' metric, will be available on Apple Watch Series 9, Series 10, and Ultra 2. Developed with clinical-grade data, it aims to offer an affordable alternative to traditional tests, tracking nightly metrics and providing comprehensive reports for users to share with healthcare providers.

Novo Nordisk's liraglutide Phase III trial in children under 12 showed a 13-point increase in Likelihood of Approval (LoA) to 50% for obesity. Pfizer's maplirpacept saw its Phase Transition Success Rate (PTSR) drop after a Phase I trial termination. Vaxcyte's VAX-31 pneumonia vaccine and Atsena Therapeutics' ATSN-101 for Leber Congenital Amaurosis (LCA) both reported positive Phase I/II trial results, increasing their PTSR. Les Laboratoires Servier's oncology Phase I trial termination led to a decline in PTSR for S-64315 and S-65487 in non-Hodgkin lymphoma (NHL), acute myeloid leukaemia (AML), and multiple myeloma (MM).

Apple Watch receives FDA approval for sleep apnea detection.