Bristol Myers Squibb Co. (BMS) and Eisai Co. Ltd. inked a potential $3.1 billion agreement to co-develop and co-commercialize the antibody-drug conjugate (ADC) MORAb-202 for advanced solid tumors. Eisai’s first ADC, MORAb-202 pairs the company’s anti-folate receptor alpha (FRα) antibody with the Tokyo-based firm’s anticancer agent eribulin using an enzyme cleavable linker. It is characterized as a potential best-in-class candidate and is under investigation for tumors that include endometrial, ovarian, lung and breast cancers in two studies: a phase I effort in Japan and a phase I/II experiment in the U.S. The companies plan to enter the registrational stage of development as early as 2022.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has been stepping up efforts to bring innovative medical devices to market faster and make the regulatory approval process more predictable and further speed up approval processes that have been known for long delays.
Daiichi Sankyo Co. Ltd. has received conditional approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its oncolytic virus Delytact (teserpaturev) to treat malignant glioma.
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.
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