With 10 cases of serious shock and anaphylaxis, including one death, in the month since Seikagaku Corp.’s osteoarthritis drug, Joyclu (diclofenac etalhyaluronate sodium), launched in Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) issued a blue letter to health care professionals and is adding a warning section to the drug’s Japanese label.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warns about differing complication rates for acellular dermal matrix; CDC and NIH initiate COVID-19 self-testing pilot program; GHIT invests $21M; MHRA updates guidance.
HONG KONG – Seikagaku Corp. and Ono Pharmaceutical Co. Ltd. have cleared the final hurdle for Joyclu (diclofenac etalhyaluronate sodium), with Japan’s Ministry of Health, Labour and Welfare granting manufacturing and marketing approval for the osteoarthritis (OA) therapy, the first agent to be approved in Japan for improving hip joint function in OA. The intra-articular injection was also approved for the treatment of knee joint OA.
HONG KONG – Eisai Co. Ltd. has received not one, but two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW), for its anticancer agent Remitoro (denileukin diftitox) and multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate).
HONG KONG – Chugai Pharmaceutical Co. Ltd. has obtained Ministry of Health, Labor and Welfare (MHLW) approval for a combination regimen containing antimicrotubule binding anti-CD79b monoclonal antibody Polivy (polatuzumab vedotin), bendamustine and Mabthera (rituximab) to treat relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
HONG KONG – Johnson & Johnson Vision (J&J Vision) has received its first global approval from Japan for its Acuvue Theravision with Ketotifen contact lenses. The Japanese Ministry of Health, Labour and Welfare’s green light will help with patients with vision correction, while simultaneously alleviating ocular allergic symptoms for allergic conjunctivitis, while they wear the lenses.
HONG KONG – Eisai Co. Ltd. has received not one, but two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW), for its anticancer agent Remitoro (denileukin diftitox) and multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate). Both approvals, each for a rare disease indication, were granted based on phase II trial results, instead after the usual phase III trials.
HONG KONG – Otsuka Pharmaceutical Co. Ltd. is celebrating its 100th anniversary by inking a collaboration and licensing agreement with Perception Neuroscience LLC to develop and commercialize the latter’s PCN-101 (r-ketamine) in Japan.
HONG KONG – Otsuka Pharmaceutical Co. Ltd. is celebrating its 100th anniversary by inking a collaboration and licensing agreement with Perception Neuroscience LLC to develop and commercialize the latter’s PCN-101 (r-ketamine) in Japan. The treatment targets mood disorders such as major depressive disorder and treatment-resistant depression. Perception is also developing PCN-101 to treat TRD outside Japan.
TORONTO – The University of Toronto (U of T) is collaborating with Kawasaki, Japan’s Fujitsu Laboratories Ltd. to dramatically streamline radiation treatment plans for Gamma Knife brain tumor radiosurgery. Together, they are leveraging Fujitsu's Digital Annealer described as quantum-inspired computing technology to create treatment plans for complex surgical procedures in minutes, while maintaining accuracy and minimizing dosage to surrounding healthy tissue.
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