GlaxoSmithKline

AstraZeneca's Fasenra gains FDA approval for EGPA, challenging GSK's Nucala. Both drugs had comparable sales in 2022, with GlobalData predicting similar sales by 2029. Fasenra's Phase III MANDARA trial showed non-inferiority to Nucala in EGPA treatment.

GSK's phase 3 trial shows non-inferior immune responses, reactogenicity, and safety when co-administering Arexvy (RSV vaccine) and Shingrix (shingles vaccine) in adults 50+ compared to separate administration, aiming to simplify vaccination regimens.

GSK's phase 3 trial (n=530) showed co-administration of Arexvy (RSV) and Shingrix (shingles) vaccines in adults aged 50+ elicited noninferior immune responses compared to separate administration, with comparable adverse events. Findings support regulatory submissions for co-administration approval, aiming to reduce healthcare visits and improve vaccination rates.

AstraZeneca’s Fasenra met primary endpoint in MANDARA trial, showing non-inferiority to GSK’s Nucala for EGPA, a rare vasculitis. Both drugs target eosinophils and are under investigation for multiple conditions. GlobalData forecasts comparable sales by 2029.

GSK unveiled Phase III data for co-administering RSV vaccine Arexvy and shingles shot Shingrix, showing non-inferior immune response and acceptable safety profile. The company plans to use these data for regulatory submissions to the FDA and EMA, aiming to boost sales. Arexvy, the first approved RSV vaccine, contributed $859 million in its first commercial quarter, while Shingrix sales exceeded $4.3 billion in 2023 but have slowed due to Medicare rule changes.

Pharmaceutical industry inefficiencies stem from high costs per drug approval, frequent C-level executive changes, and strategic R&D restructuring unrelated to science. AI-drug discovery companies should commit to programs until Phase I completion to avoid waste and maximize patient benefit.

Organon plans to acquire Dermavant for up to $1.2 billion, gaining its commercialized plaque psoriasis drug Vtama, which is under FDA review for atopic dermatitis. Vtama sales grew to $75.1 million in FY2023, but face competition in a crowded market. Organon aims to leverage its global scale to expand Vtama's reach.

Douglas B. Snyder joins IDEAYA Biosciences as SVP, General Counsel, bringing over 25 years of legal experience from GW Pharmaceuticals, Actelion Pharmaceuticals, Eisai, GSK, and the U.S. FDA.

Japan’s Ministry of Health, Labour, and Welfare accepted an NDA for belantamab mafodotin (Blenrep) plus bortezomib and dexamethasone or pomalidomide and dexamethasone in relapsed or refractory multiple myeloma, supported by phase 3 DREAMM-7 and DREAMM-8 studies showing progression-free survival benefits. A trend toward overall survival was observed, though not statistically significant. A Japan expansion cohort will further examine these protocols.

Life-science firms are enhancing clinical trial diversity through partnerships, such as GSK's new leadership role and Trial Equity's collaboration with Miller Tanner Associates, which promotes eLearning and diversity workshops to address infrastructure gaps in recruiting diverse patient populations.