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February 04, 2021
The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.
PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.
February 02, 2021
FDA puts applications on hold as the agency limits alternative oversight methods.
February 01, 2021
With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies.
January 29, 2021
The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.
FDA published guidance that includes risk-based recommendations for minimizing the potential transmission of COVID-19.
The vaccine is 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.
The vaccine met the primary endpoint with a vaccine efficacy of 89.3% in its Phase III trial in the United Kingdom and a vaccine efficacy of 49% in HIV-positive participants and 60% in HIV-negative participants in a South African Phase IIb trial.
The company is recalling one lot of Cisatracurium Besylate Injection, USP 10mg per 5mL because of mislabeling.
The dispute between the European Commission (EC) of the European Union and pharmaceutical company AstraZeneca continues.