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.
Japan’s Kyowa Kirin Co. Ltd. has stopped development of its adenosine A2a receptor antagonist, KW-6356, in Parkinson’s disease. Discovered internally by Kyowa Kirin, KW-6356 was studied in phase II trials in Japan for Parkinson’s disease, with results showing it was “potentially effective in relieving motor and non-motor symptoms both as a monotherapy and in combination with levodopa-containing therapy,” Kyowa said. However, development is now being discontinued after conducting an evaluation of the global regulatory landscape, development hurdles and potential timelines for market entry.
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