GSK has announced positive results from its clinical trial of AREXVY, a vaccine for respiratory syncytial virus (RSV) in older adults. The AReSVi-006 phase III trial found that the vaccine provided protection against RSV-lower respiratory tract disease and severe disease over two full RSV seasons, including in participants with underlying medical conditions. Safety and reactogenicity data were c..
Aldeyra Therapeutics has reported that its Phase III trial of Reproxalap, a drug for treating allergic conjunctivitis and dry-eye disease, has produced positive results. The liquid eye drop formulation of the small-molecule modulator of reactive aldehyde species demonstrated statistically significant reductions in eye itchiness across the 11 primary endpoint comparisons for patients treated with..
Clene has announced positive results from the HEALEY ALS Platform Trial, revealing that CNM-Au8 led to significant reductions in plasma neurofilament light chain concentrations in patients with amyotrophic lateral sclerosis (ALS). The company is considering filing a New Drug Application and preparing the complete CNM-Au8 clinical data package for regulatory discussions with the FDA. Developed us..
Merck has announced that its blockbuster drug Keytruda met one of its primary endpoints in a Phase III trial for patients with esophageal cancer. The results are an important step toward full approval of the drug for this indication. Merck is now working with the FDA to update the current indication for Keytruda "to those patients whose tumors are PD-L1 positive" following positive results from ..
FibroGen, a biotech company, experienced a setback as its leading candidate, Pamrevlumab, failed to meet the primary endpoint in a Phase III trial for non-ambulatory patients with Duchenne muscular dystrophy (DMD) on background corticosteroids. The LELANTOS-1 trial tested the candidate against a placebo and found that it missed the primary study endpoint of Performance of the Upper Limb 2.0 at t..
