BioCentury
ARTICLE | Product Development

June 3 Quick Takes: Double double for BeiGene’s Brukinsa; plus Novartis, Merck-Vaxxas, Antibe, Mirum and more

June 4, 2020 1:51 AM UTC

BeiGene’s BTK inhibitor gets first China approval
BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160) said China’s National Medical Products Administration approved Brukinsa zanubrutinib in two cancer indications: chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. FDA approved the BTK inhibitor to treat MCL in November (see “BeiGene Enters U.S. Market with First Approval for In-House Pipeline”).

Delay for Novartis’ MS therapy
Novartis AG (NYSE:NVS; SIX:NOVN) said FDA has extended its review of a subcutaneous version of ofatumumab to treat relapsing multiple sclerosis, and now expects regulatory action in September. While Novartis had said in February that FDA and EMA were reviewing applications for the anti-CD20 mAb, it did not disclose a PDUFA date. An IV formulation of ofatumumab is approved as Arzerra to treat CLL...