CHMP recommends against Puma's Nerlynx

EMA's CHMP recommended against approval of oral neratinib from Puma Biotechnology Inc. (NASDAQ:PBYI) for the extended adjuvant treatment of early stage HER2-positive breast cancer. Puma intends to request a re-examination of the MAA. In January, Puma said CHMP communicated a "negative trend vote" for the neratinib MAA (see BioCentury, Jan. 26)...