June 12 Company Quick Takes: Macao approves Zai's Zejula; plus Roche, NIH, CVS and Dassault-Medidata

Zai obtains Zejula's approval in Macao
Zai Lab Ltd. (NASDAQ:ZLAB) said it has received approval in Macao to market PARP inhibitor Zejula niraparib to treat ovarian cancer. Zai holds its local rights from the Tesaro Inc. unit of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). Zai markets Zejula in Hong Kong and is awaiting an approval decision from regulators in mainland China (see "China's NMPA Grants Priority Review to Zai's PARP Inhibitor").

Priority Review for rituximab in pair of rare pediatric indications
Roche (SIX:ROG; OTCQX:RHHBY) said FDA granted Priority Review to Rituxan/MabThera rituximab to treat children with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). The company did not respond to an inquiry about whether it is eligible to receive a Priority Review voucher for the rare pediatric indications. Rituximab is approved to treat adults with GPA or MPA, as well as rheumatoid arthritis...