Sandoz/Momenta’s Copaxone Generic Clears FDA, But Court Action May Guide Launch Timing
This article was originally published in The Pink Sheet Daily
Commercialization of the generic, which carries the brand name Glatopa, prior to a Federal Circuit ruling seems highly unlikely because it would be “at risk” and in the face of other rulings favoring Teva.
You may also be interested in...
Deal Watch: Taking Care Of Business Before J.P. Morgan
Under Momenta/CSL autoimmune partnership, Momenta can opt in to co-development or commercialization on recombinant Fc receptor modulator or just earn a revenue stream from CSL’s efforts with the preclinical candidate. Pieris and Servier sign broad-based immuno-oncology collaboration, while Arena hands off the disappointing Belviq to Eisai.
Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely
Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.
Intercept’s OCA In NASH: When Hitting Surrogate Endpoint Is Not Enough For Accelerated Approval
Although US FDA reaffirmed its support of surrogate endpoints described in a 2018 draft guidance on NASH fibrosis, advisory committee members questioned the link to clinical benefit and said obeticholic acid’s serious risks made it difficult to consider the effect on the surrogate in a vacuum.