AstraZeneca

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.

The global Biotechnology Market is projected to reach USD 6.24 trillion by 2032, driven by R&D investments, healthcare demand, and advancements in pharmaceuticals, agriculture, and environmental management.

AstraZeneca (LSE:AZN) reported 18% revenue growth in H1, upgraded full-year guidance, but faces rising costs and net debt. Strengths include strong revenue growth, diverse business model, and pipeline momentum. Weaknesses are high costs, modest operating profit growth, and increased net debt. Opportunities lie in expanding innovative pipeline and emerging markets growth. Threats include intense competition, regulatory challenges, and economic factors.

Cutaneous lupus erythematosus (CLE), idiopathic inflammatory myopathies (IIM), systemic sclerosis (SSc), and lupus nephritis (LN) are autoimmune diseases with significant morbidity and unmet medical needs. Phase III trials LAVENDER, JASMINE, IRIS, and DAISY evaluate the efficacy and safety of anifrolumab (Saphnelo), a type I IFN receptor blocker, in treating these conditions. AstraZeneca's Respiratory & Immunology division aims to address chronic, debilitating diseases through innovative medicines.

AstraZeneca to launch Palivizumab (Synagis) in India in October 2024, approved by DCGI in September 2023 for RSV prevention in high-risk children: preterm infants, BPD patients, and those with CHD.

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.

DelveInsight's 'Adrenoleukodystrophy Pipeline Insight, 2024' report details 11+ treatment therapies by 10+ companies, including Autobahn Therapeutics, Viking Therapeutics, and SwanBio Therapeutics. Emerging therapies like ABX-002, VK0214, and SBT101 are expected to impact the market. Minoryx Therapeutics plans to re-examine Nezglyal's approval after CHMP's refusal.

FluMist, a needle-free nasal spray, is now approved for self-administration in the US by adults up to 49 years and by caregivers for individuals 2-17 years. This approval aims to increase influenza vaccination accessibility and reduce disparities, addressing the significant annual burden of influenza.

Higher fucosylation and sialylation of serum proteins linked to worse outcomes in advanced RCC with nivolumab plus cabozantinib and sunitinib, according to CheckMate-9ER study. Serum glycoproteins involved in complement cascade and lipid metabolism may predict response to nivolumab plus cabozantinib vs sunitinib. Early exploratory work suggests glycosylation could be a focus for further biomarker development in RCC.