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Latest From Apotex Inc.

Deal Watch: Molecular Templates Aligns With Vertex On Optimizing Stem Cell Candidates

Alliance with Molecular Templates may help advance efforts under Vertex’s existing collaboration with CRISPR Therapeutics. Dragonfly’s latest partner for its TriNKET platform is AbbVie.

Deals Business Strategies

Apotex Is Blocked On Canadian Abiraterone

Apotex has failed to convince a Canadian federal court that a patent protecting Janssen’s Zytiga abiraterone brand until August 2027 is invalid and not infringed by its proposed generic version of the prostate-cancer treatment.

Intellectual Property Canada

ANDA Sponsors Urged To Ask DMF Holders About 'Hidden Facilities'

FDA says 16% of ANDAs have an issue with "hidden facilities" that are listed in drug master files but not the ANDAs they are linked with; industry official offers some tips to bridge this communications gap with DMF holders.

Manufacturing Quality

Teva And Cipla Will Have ANDAs Withdrawn

Watson (now Teva) and InvaGen (now Cipla) failed to submit new bioequivalence data following enforcement action against Cetero Research.

Regulation Approvals
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