The companies unblinded data from CARTITUDE-4, which met its primary endpoint, but analysts citing KOLs said they continue to face issues with limited manufacturing slots and out-of-spec product.

Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.

Mayne Pharma and partner Mithra have announced the launch of their Haloette generic version of NuvaRing in the US, adding further competition to a field that already includes Amneal and Teva as well as Prasco’s authorized generic.

Former employees at the Association for Accessible Medicines detail problems that emerged during Leonard’s tenure, but also say the board of directors must improve its management of the trade organization.