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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should take a risk-based approach to assess the need for drug-drug interaction (DDI) studies, the FDA said in a new draft guidance.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
Gilead Sciences said it should be able to meet international demand for remdesivir in October, thanks to improvements in its own processes and an expanded manufacturing network. Read More
The FDA has approved GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) for the treatment of adults with elapsed or refractory multiple myeloma who have received at least four prior therapies. Read More
Drugmakers successfully completed a majority of postmarketing requirements and commitments in fiscal 2019, the FDA said it its latest annual report. Read More