Teva and Corcept have been locked in US Hatch-Waxman proceeding for more than five years over the Israeli firm’s generic version of the originator’s Korlym (mifepristone) 300mg tablets, a process long enough for an initial trial to be vacated and Teva to be awarded US Food and Drug Administration approval for its generic, with the lapse of the agency’s 30-month stay on approval.
US Court Brushes Off Teva’s Early US Korlym Strike, Trial Possible
Motions Filed By Teva And Corcept For Summary Judgment Denied
Two-year-old summary judgments have finally been addressed by a US district court.
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Bringing in sales that translated to nearly $1.5bn last year, Japan’s Towa was feeling upbeat after a challenging few years, both for itself and the broader Japanese generics market. However, its financial guide for the next 12 months has left investors feeling cold.
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Off-patent drug trade groups expressed their concerns that personnel and expertise cuts will affect the agency’s ability to review and approve generics and biosimilars.
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Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
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FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.