REGULATORY

Approvals for Epclusa, Keytruda’s MSI-H Indication and More Could Be Delayed into 2019

December 21, 2018
Official stamps of approval for an array of new drugs that cleared health ministry panels in November-December might be delayed into early next year, including Gilead Sciences’ hepatitis C combo Epclusa (sofosbuvir + velpatasvir), and what would be Japan’s first…

To read the full story

Related Article

REGULATORY

By Shinya Sato

As 2019 rolls in, we expect to see a flurry of approvals in the Japanese regenerative medicine arena, with regulatory decisions anticipated by the end of the year for Novartis Pharma’s CAR-T therapy and many more products, which could bring…

Takeda Pharmaceutical completed the £46 billion acquisition of Shire on January 8, vaulting itself into the top 10 league of…

By Gregory Ng

To many people, Japan has always been one of the world’s most advanced economies and a market of rich opportunities with one of the top healthcare systems worldwide.Add a rapidly changing demographic, a declining workforce, and the constant challenges of…

By Reiji Anasako

While generic drugs post solid growth in volume-based shares in Japan, their makers are pondering ways to retool their business…