SAKIGAKE Designation System in Japan (similar to Fast Track/Breakthrough Therapy in the US) As described in the article “先駆け審査指定制度｜AnswersNews Plus (ten-navi.com)” released by AnswersNews on 15/03/2019, the SAKIGAKE designation system is a program that grants preferential treatment to innovative products such as pharmaceuticals, medical devices, regenerative medicine products, and in vitro diagnostic drugs that are applied for […]
VALIDANT GROUP ANNOUNCES NEW LEADERSHIP Tim Dietlin Joins the Company as CEO WASHINGTON, D.C. – The Validant Group, a leading international quality, compliance, and regulatory consulting firm, today announces that Tim Dietlin has joined the company in the role of Chief Executive Officer (CEO). “Tim brings a unique skill set to his role as CEO […]
HAE Product, BERINERT SC, Listed in NHI Pricing List CSL Behring’s BERINERT SC was approved for prevention of acute hereditary angioedema attacks, HAE, in September 2022. Efficacy and safety of the product based on results of COMPACT study, global Ph 3, COMPACT extension study and Japanese Ph 3 study were evaluated by PMDA. The duration […]
The 3rd PD-1 Inhibitor, LIBTAYO, approved in Japan Sanofi’s LIBTAYO, Cemiplimab IV, was approved in December 2022 Based on results of global Ph 3 EMPOWER-Cervical 1 study, of which duration was around 6 years. This is the 3rd approval for PD-1 inhibitor in Japan following Opdivo and Keytruda. It was approved to treat patients with advanced […]
Announcement of 2023 Drug Price Revision in Japan The 2023 revision of drug prices in Japan has been announced With 600 drugs being eligible for the price maintenance premium (PMP) and 1,100 drugs eligible for the unprofitable drug reassessment. The PMP will provide an additional 0.1% to 1.0% premium for the first three years of […]