Unrelated US FDA inspection led contract manufacturer to stop filling Wegovy syringes before alternate manufacturing facilities became available.
Novo Nordisk A/S’s US obesity sales force had just gathered in Las Vegas, NV, to prepare for the launch of its Wegovy (semaglutide) weight-loss drug when the company learned on 17 December that it would produce very little new product for at least six months due to manufacturing quality issues.
Initial sales exceeded all expectations. But production sharply declined after the contract manufacturing organization chosen for initial production responded to...
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.
