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Phase 3

All articles tagged with #phase 3

New Four-Dose Lyme Vaccine Shows About 70% Protection
health13 days ago

New Four-Dose Lyme Vaccine Shows About 70% Protection

Pfizer and Valneva announced phase 3 results for PF-0730740, a four-dose Lyme disease vaccine that achieved about 70% efficacy in preventing infection among people aged 5+ across the US, Canada, and Europe. The regimen requires four injections (two two months apart, then months five–nine, then one year later) and the vaccine is not yet approved; its impact on disease complications is unknown, but it could offer meaningful protection for those in endemic areas while continued tick-prevention steps remain important.

via Women's Health|
#health#lyme-disease#pfizer
AZ's tozorakimab delivers COPD benefit across populations in Phase 3
healthcare14 days ago

AZ's tozorakimab delivers COPD benefit across populations in Phase 3

AstraZeneca's anti-IL-33 antibody tozorakimab posted positive Phase 3 results in COPD (Oberon and Titania), reducing the annualized rate of moderate-to-severe exacerbations versus placebo in former smokers and showing benefit across the overall population, with a favorable safety profile. The drug’s supposed differentiation comes from complete inhibition of ST2 and RAGE/EGFR signaling, unlike rivals Roche and Sanofi/Regeneron’s IL-33 blockers that produced mixed results. AZ plans to present full data at an upcoming meeting and is pursuing two additional Phase 3 trials (Prospero, Miranda), while maintaining a target of potentially $3–5 billion in peak sales if approved.

via Fierce Biotech|
#astrazeneca#copd#healthcare
Lilly's retatrutide delivers strong A1C drops and meaningful weight loss in first Phase 3 Type 2 diabetes trial
health23 days ago

Lilly's retatrutide delivers strong A1C drops and meaningful weight loss in first Phase 3 Type 2 diabetes trial

Lilly reports positive topline results from TRANSCEND-T2D-1, a Phase 3 trial of retatrutide, a once-weekly triple hormone receptor agonist (GIP, GLP-1, glucagon), showing up to a 2.0% reduction in A1C and about 17% body-weight loss at 40 weeks versus placebo, with dose-dependent effects and continued weight loss through the treatment period. The most common side effects were gastrointestinal (nausea, diarrhea, vomiting) largely during dose escalation, with some dysesthesia but generally manageable. Results met primary and key secondary endpoints and will be detailed at the ADA Scientific Sessions in June; Lilly plans to publish additional data from the retatrutide program over the next year.

via Eli Lilly|
#a1c#health#phase-3
Vertex reports strong Week 36 interim results for povetacicept in IgA nephropathy
health1 month ago

Vertex reports strong Week 36 interim results for povetacicept in IgA nephropathy

Vertex’s povetacicept demonstrated robust Week 36 interim efficacy in the Phase 3 RAINIER trial for IgA nephropathy, including a 52.0% reduction in 24-hour UPCR (49.8% versus placebo, P<0.0001), a 77.4% reduction in serum Gd-IgA1 (79.3% versus placebo; P<0.0001), and 85.1% hematuria resolution versus 23.4% with placebo (61.7-point difference; P<0.0001). The drug was generally safe and well tolerated. Vertex plans full BLA submission by end of March for potential accelerated FDA approval, with final efficacy analysis scheduled at two years through Week 104.

via Vertex Pharmaceuticals Newsroom|
#baff-april#health#iga-nephropathy
FDA orders phase 3 for Huntington's gene therapy, delaying uniQure's path to approval
health1 month ago

FDA orders phase 3 for Huntington's gene therapy, delaying uniQure's path to approval

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.

via Fierce Biotech|
#amt-130#fda#health
Compass’s psilocybin therapy advances toward FDA nod in severe depression
biotech1 month ago

Compass’s psilocybin therapy advances toward FDA nod in severe depression

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).

via statnews.com|
#biotech#comp360#compass-pathways
Novavax's COVID-Influenza Vaccine Candidates Demonstrate Strong Immune Response in Phase 3 Trial
health10 months ago

Novavax's COVID-Influenza Vaccine Candidates Demonstrate Strong Immune Response in Phase 3 Trial

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.

via Novavax Investor Relations|
#covid-19#health#influenza
"Insider Insights: WoW Season of Discovery Phase 3 Highlights and Controversies"
gaming2 years ago

"Insider Insights: WoW Season of Discovery Phase 3 Highlights and Controversies"

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.

via Dexerto|
#game-updates#gaming#phase-3
"Unveiling WoW Classic's Season of Discovery Phase 3: Level Cap Raised, New Runes, Raid, and the Unruly Emerald Dream"
gaming2 years ago

"Unveiling WoW Classic's Season of Discovery Phase 3: Level Cap Raised, New Runes, Raid, and the Unruly Emerald Dream"

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.

via PC Gamer|
#gaming#level-cap#new-content
"Balancing Act: Evaluating the Impact of New EPA Rules on Heavy-Duty Vehicles and Electric Truck Sales"
environmental-policy2 years ago

"Balancing Act: Evaluating the Impact of New EPA Rules on Heavy-Duty Vehicles and Electric Truck Sales"

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.

via U.S. EPA.gov|
#environmental-policy#epa#greenhouse-gas-emissions
"Pridopidine Phase 3 Trial for ALS Patients Expected This Year"
health-medicine2 years ago

"Pridopidine Phase 3 Trial for ALS Patients Expected This Year"

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.

via ALS News Today|
#als#clinical-trial#health-medicine