Copaxone Supreme Court Case Could Cut Relitigation Of Patent Claims
Supreme Court to hear oral arguments in case that could restrict the ability of the Federal Circuit to overturn certain rulings on patent claim terms; Google, Intel and other tech companies back Sandoz.
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Teva’s Copaxone Patent Win Delivers Bigger Blow To Sandoz Than Mylan
Sandoz, which has first to file on the generic, may have the most to lose after federal judge finds that Mylan and Sandoz ANDAs for generic Copaxone infringe all the claims in Teva’s patents, the latest of which expires in September 2015. FDA now has more time to review the ANDAs without pressure.
Device Component Of Intarcia’s Diabetes Treatment ITCA 650 Worries FDA
If FDA chief scientist grants Intarcia’s request for advisory committee meeting, CDER wants to provide input on issues to be considered. Director Cavazzoni says the novel drug-device combination product does not notify the user of a critical failure or infusion status.
Paxlovid Gets FDA Panel Backing For Full Approval; Combating Rebound Misperception Urged
Patient advocate is sole committee member to vote against Paxlovid favorable benefit-risk profile, saying doctors do not know how to use the treatment. Members suggest conducting natural history studies on COVID rebound and publishing data that shows no clear association with Paxlovid.