AstraZeneca Plc is a holding company, which engages in the research, development, manufacture, and commercialization of prescription medicines. The company was founded on June 17, 1992 and is headquartered in Cambridge, the United Kingdom.
FDA approves Sanofi and AstraZeneca's new filling line for Beyfortus, enabling expanded manufacturing capacity and supply in the U.S. for the 2024/2025 RSV season. Beyfortus, a long-acting antibody, was FDA-approved in July 2023 for infants and children up to 24 months old at severe risk of RSV infection. CDC analysis in March 2024 showed Beyfortus 90% effective at preventing RSV hospitalization.
Solid tumors market projected to reach $375.4B by 2034 with 7.45% CAGR. Aethlon Medical activates Hemopurifier trial at Royal Adelaide Hospital for solid tumor patients resistant to anti-PD-1 therapies. Immuneering reports positive initial data for IMM-1-104 in pancreatic cancer. FDA approves new immunotherapy combinations for endometrial cancer from AstraZeneca, Merck, and GlaxoSmithKline. Roche's trastuzumab deruxtecan receives accelerated approval for HER2-positive solid tumors.
The NIAGARA study showed AstraZeneca's Imfinzi improved event-free survival in muscle-invasive bladder cancer, with a 25% reduction in death risk. This contrasts with Bristol Myers Squibb's Opdivo, which was previously approved for adjuvant use. The FDA's cautious stance on perioperative studies may delay Imfinzi's approval, despite its potential impact. Other ongoing trials, like KEYNOTE-866 and VOLGA, aim to further evaluate immunotherapies in this setting.
AstraZeneca's Phase III HIMALAYA trial of Imfinzi (durvalumab) plus Imjudo (tremelimumab) showed a 24% reduction in death risk in advanced liver cancer patients, with 19.6% surviving five years, compared to 7% historically.
AstraZeneca's Phase III NIAGARA study shows perioperative Imfinzi regimen significantly reduces risk of disease progression, recurrence, and death by 32% and 25% respectively in muscle-invasive bladder cancer patients, with no new safety signals.
The HIMALAYA study's 5-year survival analysis shows 19.6% survival with STRIDE (durvalumab plus tremelimumab) vs 9.4% with sorafenib in unresectable hepatocellular carcinoma, with no new safety concerns.