With the White House putting a spotlight on US shortages of their new RSV monoclonal antibody, Sanofi and AstraZeneca can take some solace that the negative headlines stem from unexpectedly high demand and easier reimbursement for the immunization than the companies’ predicted.
Sanofi and AstraZeneca PLC are plugging the US shortage of their RSV immunization for infants by providing 230,000 doses originally intended for the Southern Hemisphere RSV season to the US, Sanofi told the Pink Sheet.
Those doses of Beyfortus (nirsevimab-alip), a monoclonal antibody used to prevent lower respiratory syncytial virus infections in infants, are expected...
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.
