Nektar Digs Into Mid-Stage Data To Establish Alopecia Efficacy of Rezpeg

Nektar Therapeutics; rezpegaldesleukin; Rezpeg; REZOLVE-AA; Phase 2b; alopecia areata; hair loss; SALT score; mid-stage trial; efficacy signal; Eli Lilly; IL-2 pathway; autoimmune disease; Phase 3 planning

CDC highlights strong effectiveness of 2024–2025 COVID-19 shots in kids while FDA reviews reports of alleged post-vaccination deaths

CDC; FDA; COVID-19 vaccine; children; pediatrics; vaccine effectiveness; emergency department visits; urgent care visits; safety review; alleged deaths; VAERS

CMS Unveils Negotiated Prices for Ozempic, Wegovy, and Other Drugs in Second Round of IRA Talks

CMS; Ozempic; Wegovy; Inflation Reduction Act; drug price negotiation; Medicare Part D; semaglutide; negotiated prices; 2027 effective date

Cogent Hits Unprecedented Efficacy in Rare Stomach Cancer, Clearing Path to FDA

Cogent Biosciences; bezuclastinib; unprecedented efficacy; rare stomach cancer; gastrointestinal stromal tumor (GIST); FDA submission; second-line treatment; objective response rate; progression-free survival

Dyne Therapeutics’ z-rostudirsen Shows Durable Efficacy, Supporting Positive Regulatory Outlook

Dyne Therapeutics; z-rostudirsen; DELIVER trial; Duchenne muscular dystrophy (DMD); durable efficacy; regulatory approval; biomarkers; functional improvement; accelerated approval

Lilly’s Oral GLP-1, Orforglipron, Achieves Two New Clinical Wins in Type 2 Diabetes

Lilly; Orforglipron; oral GLP-1; type 2 diabetes; clinical trial; weight loss; regulatory submission; ACHIEVE-1; ATTAIN-2; semaglutide; Farxiga; efficacy; safety

Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy

Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy