AstraZeneca

FDA grants priority review to durvalumab for muscle-invasive bladder cancer, based on NIAGARA trial results showing significant EFS and OS benefits. If approved, durvalumab would be the first perioperative immunotherapy regimen.

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AstraZeneca's Imfinzi approved in the US for limited-stage small cell lung cancer (LS-SCLC) after chemotherapy and radiation, based on ADRIATIC trial results showing improved survival and reduced risk of death and disease progression.

Eli Lilly's Zepbound showed 47% greater weight loss than Novo Nordisk's Wegovy in SURMOUNT-5 study. FDA granted Breakthrough Therapy designation to Merck's Sac-TMT for lung cancer and approved AstraZeneca's Imfinzi for LS-SCLC. Roche's Columvi sBLA accepted for review. J&J seeks approval of Tremfya for pediatric patients.

The Global AI in Biotechnology Market is projected to grow from US$ 4.5 Billion in 2023 to US$ 26.3 Billion by 2033, driven by precision medicine, drug discovery, and personalized healthcare. North America leads with a 40.8% share, and AI technologies like machine learning and natural language processing are transforming biotechnology. Key applications include drug target identification and agriculture biotechnology, with software leading in product types. Partnerships and collaborations are accelerating AI integration in biotechnology.

AstraZeneca's IMFINZI® (durvalumab) approved in the US for limited-stage small cell lung cancer (LS-SCLC) post concurrent platinum-based chemotherapy and radiation therapy, based on ADRIATIC Phase III trial results showing a 27% reduction in the risk of death versus placebo.

FDA grants Priority Review to AstraZeneca's Imfinzi for muscle-invasive bladder cancer, based on NIAGARA Phase 3 trial data showing a 32% reduction in disease progression risk. Estimated 67.8% event-free survival at two years with Imfinzi versus 59.8% in the comparator arm. Imfinzi also reduced death risk by 25% in overall survival analysis.

The GCC pharmaceutical market, led by Saudi Arabia, is rapidly expanding due to factors like population growth and lifestyle diseases. The market is expected to exceed US$ 12 Billion by 2030, with branded and imported drugs dominating. Clinical trials in the region involve over 250 drugs, and healthcare transformation programs are driving growth. Local manufacturing is increasing, especially in generics and biosimilars, while digital health innovations are enhancing market efficiency.

FDA grants priority review to durvalumab (Imfinzi) sBLA for muscle-invasive bladder cancer (MIBC). Based on NIAGARA study results, durvalumab showed significant EFS and OS benefits, with balanced adverse events. FDA decision expected in Q2 2025.

IMFINZI (durvalumab) granted Priority Review in the US for muscle-invasive bladder cancer, based on NIAGARA Phase III trial results showing significant event-free and overall survival benefits. If approved, it would be the first perioperative immunotherapy in this curative-intent setting.