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After years of discussions, Japan has revised legislation relating to the use of medicines containing cannabinoids, while also officially criminalizing the non-medical use of marijuana. The move may pave the way for easier use of medicines such as Epidiolex, for which a local Phase III trial started in 2022.
Research targeting botanicals generally, as well as cannabis, as potential APIs is increasing, a factor in CDER’s publication of cannabis trials guidance, the FDA’s Norman Birenbaum says in an interview.
FDA is formally asking Congress to weigh in on the best approach to regulate CBD in consumer products. That provides another target for legislative attention that may mean that FDA’s core drug regulatory activities stay comfortably out of the spotlight.
Verona Pharma’s Phase III ensifentrine, if approved, would be the first new dual-mechanism treatment class for COPD patients in decades. It could propel the UK-based biotech toward profitability, or into the arms of a larger partner.
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