Single neutralizing antibody moves to US FDA with data showing reduced hospitalization, while Lilly’s EUA filing for two-antibody combo awaits safety data and more certainty about production capabilities.
Eli Lilly and Company’s next step in its strategy for COVID-19 monoclonal antibodies is about doubles: The timing of when it will seek an emergency use authorization for its two-antibody combo regimen depends on two factors – safety data and manufacturing confidence.
Getting the EUA from the US Food and Drug Administration might also double the number of Lilly’s COVID antibody products....
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.
