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Regulation
With a US FDA determination that sotagliflozin cannot be approved for type 1 diabetes at this time, Lexicon is shutting down its commercial organization to focus on its R&D pipeline.
When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include Hympavzi, Pfizer's treatment for adults and adolescents with severe hemophilia A or B without inhibitors.
As mandated by the recent Pharmacare Act in Canada, a new committee will make recommendations on how Canada can provide universal drug coverage to it citizens.
As China faces the potential loss of a big customer base, the US off-patent industry starts to look for new relationships elsewhere. While building domestic manufacturing capabilities would be the ultimate American dream, the government has yet to offer the carrot, not just the stick.
The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.
Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?
“The first time we have a contact with them, if and when someone complains, is not because you're in trouble, but you already have a pre-existing relationship,” says former Maryland state AG Doug Gansler.
A short consultation has been launched by the UK MHRA on elements of devices regulation for Great Britain that have evolved since the first consultation on UKCA marking in 2021.
The European Medicines Agency has recommended against EU marketing approval for two drugs targeting children.