AstraZeneca

The mRNA Therapeutics Market was valued at USD 11.82 billion in 2023 and is projected to reach USD 48.65 billion by 2032, with a CAGR of 17.04%. The market's growth is driven by mRNA-based vaccines against COVID-19, advancements in mRNA-based cancer therapies, and regulatory approvals. North America leads the market, followed by Europe, while Asia Pacific is expected to grow the fastest.

The toxoplasmosis treatment drugs market is projected to grow from $3.16 billion in 2023 to $4.18 billion by 2028, driven by rising prevalence, product innovations, and increased healthcare expenditure.

AstraZeneca's Imfinzi granted Priority Review by FDA for muscle-invasive bladder cancer treatment, based on NIAGARA trial data showing reduced risk of disease progression and death. Imfinzi, an immunotherapy, aims to transform care by delaying recurrence and extending survival.

AstraZeneca's Imfinzi granted Priority Review by FDA for muscle-invasive bladder cancer treatment, supported by NIAGARA Phase III trial results showing 32% reduction in disease progression risk and 25% reduction in death risk when combined with neoadjuvant chemotherapy.

The FDA granted priority review to AstraZeneca's sBLA for durvalumab plus chemotherapy in muscle-invasive bladder cancer, with a Prescription Drug User Fee Act date set for Q2 2025. The decision is based on the NIAGARA trial results, showing a 32% reduction in disease progression risk and a 25% reduction in death risk with durvalumab. The regimen is under review globally.

AstraZeneca and Daiichi Sankyo's cancer drug dato-dxd showed tumor control for 6 months in EGFR-mutated lung cancer patients; Agenus plans 60% spending cut to focus on late-stage colorectal cancer immunotherapy; Amgen invests $1 billion to expand NC manufacturing; USPTO withdraws proposed rule on preventing 'patent thickets'; Bluebird bio to undergo reverse stock split; FDA grants accelerated approval to Merus' zenocutuzumab for NRG1-altered lung and pancreatic cancers.

FDA grants priority review to durvalumab (Imfinzi) for muscle-invasive bladder cancer (MIBC) based on NIAGARA trial data, showing improved event-free survival (EFS) and pathologic complete response (pCR) rates. Durvalumab, combined with neoadjuvant chemotherapy and adjuvant treatment, demonstrated a median EFS not reached compared to 46.1 months in the control arm, and a pCR rate of 37.3% vs 27.5% in the control arm. Safety profiles were similar between arms, with immune-mediated adverse events higher in the durvalumab arm.

The FDA granted Priority Review to AstraZeneca’s Imfinzi for muscle-invasive bladder cancer, based on the NIAGARA trial showing a 32% reduction in disease progression, recurrence, or death with perioperative Imfinzi plus neoadjuvant chemotherapy. Imfinzi demonstrated improved event-free survival and overall survival rates, with no new safety concerns.

FDA updates include draft guidance on accelerated drug approval, a Salmonella outbreak advisory, a report on non-device software health risks, declining youth tobacco use, a video on FDA reorganization, accelerated approval for cancer treatments, a device shortage update, and approval of a diaphragm activation system for ventilator patients.

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.