Nov. 11 Quick Takes: FDA approves Imfinzi for metastatic NSCLC 

AstraZeneca plc (LSE:AZN; NASDAQ:AZN) gained its second approval in a matter of weeks for Imfinzi durvalumab in combination Imjudo tremelimumab, with FDA on Thursday approving the drugs with platinum-based chemotherapy to treat metastatic non-small cell lung cancer (NSCLC). It was approved in late October for unresectable hepatocellular carcinoma, the most common type of liver cancer. The combination is under review for the NSCLC indication in the EU, Japan and other countries.

One year after Livtencity maribavir was approved in the U.S., the European Commission green-lighted the drug from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) for adults who experience post-transplant refractory cytomegalovirus (CMV) infection, one of the most common infections among transplant patients. Livtencity targets CMV with a novel mechanism to inhibit viral replication, differentiating itself from currently available drugs. The drug is also approved in Australia and Canada. Takeda booked Livtencity sales of ¥2 billion ($14.7 million) in 2Q22. The company has estimated Livtencity’s peak sales at more than $700 million per year...