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BRIEF-Puma Biotechnology provides update on review of marketing authorisation application for PB272
March 1, 2017 / 10:26 PM / 9 months ago

BRIEF-Puma Biotechnology provides update on review of marketing authorisation application for PB272

March 1 (Reuters) - Puma Biotechnology Inc:

* Puma Biotechnology provides update on review of marketing authorisation application for PB272

* Puma Biotechnology Inc - company plans to modify summary of product characteristics in its marketing authorisation application

* Puma Biotechnology-plans to modify summary of product characteristics based on meeting with rapporteur, co-rapporteur, review team members, EMA

* Puma Biotechnology - proposed summary of product characteristics will continue to include both hormone receptor positive, hormone receptor negative patients

* Puma-Will be revising proposed smpc for neratinib to restrict intended population to patients within a year after completion of Adjuvant Trastuzumab Therapy

* Puma-Committee for medicinal products for human use continuing to review co’s maa and has not yet made a final decision to recommend approval of drug Source text for Eikon: Further company coverage:

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