Takeda Pharmaceutical Co. Ltd.’s dengue fever vaccine, Qdenga, was approved in Indonesia Aug. 23, making it the first global approval for the tetravalent vaccine. The approval marks Takeda’s first marketed vaccine outside of Japan. Indonesia’s National Agency for Drug and Food Control approved the vaccine for prevention of dengue disease caused by any serotype in individuals 6 years to 45 years of age.
Kringle Pharma Inc.’s phase II trial evaluating its recombinant human hepatocyte growth factor ligand, oremepermin alfa, failed to meet both primary and secondary endpoints in a study of its potential to help people with amyotrophic lateral sclerosis (ALS).
Kringle Pharma Inc.’s phase II trial evaluating its recombinant human hepatocyte growth factor ligand, oremepermin alfa, failed to meet both primary and secondary endpoints in a study of its potential to help people with amyotrophic lateral sclerosis (ALS).
Shionogi & Co. Ltd. has in-licensed Japan rights to Grunenthal GmbH’s intra-articular injectable, resiniferatoxin, for the treatment of pain associated with osteoarthritis of the knee. Currently in phase III trials, RTX is a transient receptor potential vanilloid 1 agonist, which can reversibly desensitize TRPV1-expressing nociceptors. This mechanism may result in long-lasting pain relief.
The U.S. FDA has approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
Shionogi & Co. Ltd. has in-licensed Japan rights to Grunenthal GmbH’s intra-articular injectable, resiniferatoxin, for the treatment of pain associated with osteoarthritis of the knee. Currently in phase III trials, RTX is a transient receptor potential vanilloid 1 agonist, which can reversibly desensitize TRPV1-expressing nociceptors. This mechanism may result in long-lasting pain relief.
Akili Interactive Labs Inc. has kicked off a phase III study of its digital treatment for children with attention-deficit/hyperactivity disorder (ADHD) living in Japan, the first pivotal trial of its video game-based cognitive treatment outside the U.S. Conducted by Osaka-based Shionogi & Co. Ltd., this marks the first pivotal trial of Akili’s video game-based cognitive treatment outside the U.S.
As Democrats in the U.S. Senate rush to pass prescription drug pricing reforms through the reconciliation process this week, the nonpartisan Information Technology & Innovation Foundation (ITIF) is offering Japan’s experience with government price controls as a cautionary tale.
As Democrats in the U.S. Senate rush to pass prescription drug pricing reforms through the reconciliation process this week, the nonpartisan Information Technology & Innovation Foundation (ITIF) is offering Japan’s experience with government price controls as a cautionary tale. “Stringent drug price controls have significantly hampered the competitive and innovative capacity of Japan’s biopharmaceutical industry in recent decades, serving as a warning for U.S. policymakers considering introducing Medicare Part D drug price controls in 2022,” according to the ITIF.
An expert panel of Japan’s Ministry of Health, Labour and Welfare (MHLW) pushed back on recommending conditional approval for a second time for Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral 3CL protease inhibitor, S-217622, also known as ensitrelvir.
RSS
