GlaxoSmithKline

FDA approves AstraZeneca's FluMist nasal spray flu vaccine for self-administration, the first of its kind. The vaccine, available through a third-party online pharmacy, requires a screening and eligibility assessment. Individuals aged 2-17 should still receive it from a caregiver.

FDA approves FluMist nasal spray flu vaccine for self- or caregiver-administration for ages 2-49, the first such vaccine. It contains weakened live influenza virus strains and requires a prescription. Available through third-party online pharmacies with screening for eligibility.

FDA approves AstraZeneca's FluMist nasal spray flu vaccine for self-administration, the first of its kind. The vaccine, initially approved in 2003 for healthcare provider administration, will be available via third-party online pharmacies after a screening and eligibility assessment. Individuals aged 2-17 must still receive the vaccine from a caregiver.

FDA clears Eversense 365, the first 1-year CGM for diabetes. Approves lebrikizumab-lbkz for moderate-to-severe atopic dermatitis, benralizumab for eosinophilic granulomatosis with polyangiitis, and ribociclib plus aromatase inhibitor for HR+/HER2- early breast cancer.

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.