Revising the two companies’ 2017 epilepsy collaboration, Takeda will take over Phase III development and commercialization of soticlestat. Ovid gets $196m up front, and it can shift focus.

The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.

Sedgwick reported US OTC drug recalls in 2020 doubled to 61 driven by methanol contamination and GMP deviations in hand sanitizers. Once FDA resumes full inspection schedule, enforcement will be “more frequent, penalties will be harsher and cross-agency collaboration” will be welcome.