All articles tagged with #phase 3
The FDA rejected uniQure's plan to file AMT-130 using phase 1/2 data with an external control and demanded a prospective, randomized, sham-controlled phase 3 trial, dampening near-term approval hopes and triggering a strategic review by the company; uniQure will discuss trial designs with the FDA and add a four-year durability analysis to the phase 1/2 data.
Compass Pathways reports positive Phase 3 results for its psilocybin-based treatment COMP360 in two trials for severe depression, suggesting potential FDA approval, though full data are needed to confirm the magnitude of benefit; if approved, it could become the first psilocybin product on the market, following Spravato (ketamine derivative).
Novavax announced that its COVID-19-Influenza combination and stand-alone influenza vaccines elicited strong immune responses and were well tolerated in a Phase 3 trial involving adults aged 65 and older, with results comparable to existing licensed vaccines, supporting further development and potential partnerships.
Novavax announced that its COVID-19-Influenza combination and stand-alone influenza vaccines elicited strong immune responses and were well tolerated in a Phase 3 trial involving adults aged 65 and older, with results comparable to existing licensed vaccines, supporting further development and partnership discussions.
Regeneron Pharmaceuticals' stock dropped 12% after its COPD drug, developed with Sanofi, failed in a Phase 3 trial, with mixed results across two studies, potentially hindering approval efforts.
Roche is advancing its experimental antibiotic zosurabalpin into Phase 3 clinical trials to combat drug-resistant acinetobacter baumannii, a bacteria causing serious hospital infections, using a novel mode of action to which bacteria have not yet developed resistance.
World of Warcraft's Season of Discovery Phase 3 is live, with the development team addressing issues such as unexpected buffs, tuning adjustments, and missing loot in dungeons. The Sunken Temple raid and Nightmare Incursions are proving challenging for players, with the final encounter against the Avatar of Hakkar causing difficulty. Despite some issues, the phase has had a successful start, and players are able to engage in new PvE activities and content.
WoW Classic's Season of Discovery phase 3 is now live, featuring a raised level cap to 50, 54 new runes, and a 20-player raid in the Sunken Temple. The update also introduces Nightmare Incursions, allowing players to venture into the corrupted Emerald Dream. Additionally, an improved Discoverer's Delight provides XP boosts for players. To access the new content, players need an active subscription on a World of Warcraft account.
The U.S. EPA has announced a final rule, "Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles – Phase 3," to reduce greenhouse gas emissions from heavy-duty vehicles starting in model year 2027. The standards will apply to vocational vehicles and tractors, building on the 2016 Heavy-Duty Phase 2 program with a flexible, technology-neutral, and performance-based approach, allowing manufacturers to choose emissions control technologies that best suit their needs and those of their customers.
Prilenia Therapeutics plans to launch a pivotal Phase 3 study of pridopidine, a potential amyotrophic lateral sclerosis (ALS) treatment, following promising Phase 2 trial data showing slower disease progression, improved quality of life, and potential survival prolongation in early-stage ALS patients. Pridopidine, designed to activate the sigma-1 receptor, aims to slow ALS progression by boosting nerve cell function and survival. While the Phase 2/3 trial did not meet its main goal, pridopidine showed significant improvements in speech measures and slowed declines in respiratory function and overall life quality, particularly in early, fast-progressing ALS patients. Pridopidine was well tolerated, and its continued development is supported by an ongoing expanded access program and orphan drug designation in the U.S. and Europe.