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China-based CanSino Biologics is preparing a phase 3 trial of its COVID-19 vaccine in Saudi Arabia, the country’s Ministry of Health has announced. Read More
Gilead Sciences announced yesterday that it has filed a new drug application (NDA) with the FDA, seeking approval for remdesivir for the treatment of COVID-19 patients. Read More
The European Medicines Agency’s suspended the marketing authorizations of generic drugs tested by Panexcell Clinical Laboratories at its site in Mumbai, India. Read More
The European Medicines Agency (EMA) has updated its advice on impurity testing for nitrosamines, expanding it to include some biological medicines. Read More
Bristol Myers Squibb and collaborator Pfizer prevailed in a patent ruling last week when a Delaware federal judge upheld two patents for their blockbuster blood thinner Eliquis (apixaban). Read More
Sponsors of investigational new drug (IND) applications or biologic license applications (BLAs) for a therapeutic protein should take a risk-based approach to assess the need for drug-drug interaction (DDI) studies, the FDA said in a new draft guidance. Read More
The Trump administration has said that the Department of Defense (DOD) will take the lead in distributing the COVID-19 vaccines secured under Operation Warp Speed, but some lawmakers are concerned that the administration has not yet released details of how that will be done. Read More
The Serum Institute of India has partnered with the Bill & Melinda Gates Foundation and Gavi, the Vaccine Alliance to manufacture 100 million doses of COVID-19 vaccines for low- and middle- income countries. Read More
Maryland-based Novavax has teamed up with Takeda Pharmaceutical Co. to commercialize Novavax’s COVID-19 vaccine candidate NVX-CoV2373 in Japan. Read More