COVID-19 - March 23, 2021
NIAID statement on AZD1222 US Phase III trial data
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the […]
COVID-19 - March 22, 2021
Interim analysis results of AstraZeneca’s AZD1222
The AstraZeneca US Phase III trial of AZD1222 demonstrated vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization. This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19, reports AstraZeneca in a press release. The trial had a 2:1 randomization […]
COVID-19 - March 19, 2021
MHRA & PRAC announce review of the safety of AstraZeneca’s vaccine
The Medicines Health Regulatory Authority (MHRA) and European Medicines Agency (EMA) reaffirmed the benefits of COVID-19 Vaccine AstraZeneca continue to far outweigh the risks. The MHRA announced their review of the thromboembolic events in over 11 million people who received COVID-19 Vaccine AstraZeneca in the UK. The UK regulator confirmed that the benefits of the […]
Intellectual Property - March 4, 2021
US court decision favors Symbicort in patent litigation
The US District Court for the Northern District of West Virginia has decided in favor of AstraZeneca in litigation against Mylan Pharmaceuticals and Kindeva Drug Delivery, determining that asserted claims in three of AstraZeneca’s patents protecting Symbicort (budesonide/formoterol) in the US are not invalid. “AstraZeneca is pleased with the Court’s decision, and we maintain full […]
COVID-19 - March 3, 2021
AstraZeneca and Serum Institute of India will be the biggest initial supplier to COVAX
AstraZeneca advances mass global rollout of COVID-19 vaccine through the multilateral COVAX initiative. Supply to 142 countries is underway as part of the effort to bring broad and equitable access to the vaccine, the company states in a press release. “These first steps towards fulfilling our broad, equitable and no-profit emergency response to the pandemic […]
Pharma Business - February 23, 2021
Voluntary withdrawal of Imfinzi indication in advanced bladder cancer
AstraZeneca has announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer. This decision was made in consultation with the Food and Drug Administration (FDA). Aligned with FDA guidance In May 2017, Imfinzi was granted accelerated approval in the US based on promising […]
