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September 21, 2020
The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.
September 18, 2020
The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.
The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.
The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.
The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.
September 17, 2020
The Russian Direct Investment Fund has announced three deals with India, Brazil, and Mexico, for the supply of doses of Sputnik V, a potential COVID-19 vaccine.
September 16, 2020
Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.
The funding will help advance the vaccine’s clinical evaluation, potential marketing authorization, development and manufacturing in Germany, and the number of participants in late-stage clinical trials.
September 15, 2020
GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.
September 14, 2020
The White House issued an executive order Sunday, Sept. 13, 2020 implementing a policy to link payments for medicines provided through Medicare to prices charged in other industrial countries.