US government to own doses of Regeneron's investigational cocktail antibody REGN-COV2 manufactured under a $450m contract and 100 million doses of Novavax's investigational vaccine under a $1.6bn agreement.
The US government's Operation Warp Speed is providing $450m to Regeneron Pharmaceuticals, Inc. to support large-scale manufacturing of its investigational COVID-19 therapeutic and $1.6bn to Novavax, Inc. for late-stage clinical development and large-scale manufacturing of its COVID-19 vaccine candidate.
The awards are a boon for the companies, as ramping up production for worldwide supply of COVID-19 products is a...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
