Clinical Trials - September 13, 2021
New results from AstraZeneca’s POSEIDON trial
Positive results from the Phase III trial showed that AstraZeneca’s Imfinzi and tremelimumab, when added to platinum-based chemotherapy, demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone in the 1st-line treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). “The POSEIDON […]
Pharma Business - September 6, 2021
AstraZeneca’s Ultomiris approved in the EU
Ultomiris (ravulizumab) has been approved in the European Union for expanded use to include children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH), an ultra-rare and severe blood disorder characterized by the destruction of red blood cells that can cause thrombosis (blood clots) and result in organ damage and potentially premature death. The approval by the […]
New Market - September 1, 2021
AstraZeneca’s Forxiga approved in Japan
AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in Japan for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the DAPA-CKD Phase III trial. The decision follows […]
Clinical Trials - August 31, 2021
AstraZeneca’s FoCus Phase III trial met primary endpoint
Positive results from the trial in Wilson disease showed that ALXN1840 met the primary endpoint with a statistically significant improvement in daily mean copper mobilization from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments. The primary endpoint gauged the daily mean Area Under the Effect Curve (AUEC) for directly measured non-ceruloplasmin-bound copper (dNCC) over 48 […]
COVID-19 - August 24, 2021
AstraZeneca’s PROVENT trial met primary endpoint
AZD7442, a combination of two long-acting antibodies (LAAB), reduced the risk of developing symptomatic COVID-19 by 77%, compared to placebo. The Phase III trial accrued 25 cases of symptomatic COVID-19 at the primary analysis. There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. In the placebo arm, there were […]
Clinical Trials - August 23, 2021
AstraZeneca discontinues CHAMPION-ALS trial
Alexion, AstraZeneca Rare Disease, is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS). Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. “We are disappointed by this outcome and what it means […]
