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...
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.
Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.
Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.