FDA says Teva and Apotex’s generic products do not violate the ‘same labeling’ requirement because they were produced by different manufacturers and that braille is not necessary for safe and effective use of tasimelteon products. Vanda's generic labeling suit against the FDA remains pending.

FDA says Teva and Apotex’s generic products do not violate the ‘same labeling’ requirement because they were produced by different manufacturers and that braille is not necessary for safe and effective use of tasimelteon products. Vanda's generic labeling suit against the FDA remains pending.

Arbutus Biopharma alleges Moderna refused to license patents covering its lipid nanoparticle delivery platform in developing Spikevax. Moderna says it created its own proprietary LNP delivery technology.

Among the topics at the European liver meeting was whether reducing HBV surface antigen might be part of a combination approach to curing chronic hepatitis B. One of the leaders in this approach, Arbutus, is working toward its own internal combo therapy for the virus.