Nov. 22 Company Quick Takes: AZ’s Btk inhibitor gains expanded approval; plus WuXi Vaccines, SK Bio, ViiV, Horizon and Neon

Label expansion for AZ’s Calquence under Project ORBIS
FDA approved an sNDA for Calquence acalabrutinib from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat chronic lymphocytic leukemia and small lymphocytic leukemia under the agency’s Real-Time Oncology Review and the Project ORBIS program. Project ORBIS, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, allows for concurrent submission and review of cancer drugs in multiple countries with the aim of speeding patient access to new therapies. The Btk inhibitor received accelerated approval to treat mantle cell lymphoma in 2017 (see “FDA’s International Drug Review Pilot”).

WuXi Biologics’ vaccine JV building $240M Ireland site
WuXi Vaccines said it will invest $240 million to build a new vaccine manufacturing facility in Ireland. The company, which is a JV between WuXi Biologics Inc. (HKEX:2269) and Shanghai Hile Bio-Technology Co. Ltd. (Shanghai:603718), in May entered into a 20-year deal worth more than $3 billion to supply an undisclosed company with commercial vaccine product...