NLS New Market

Saphnelo (anifrolumab) has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE), a serious autoimmune disease. The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on efficacy and safety data from the Saphnelo clinical development programme, including the TULIP Phase III trials and the […]

AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in Japan for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the DAPA-CKD Phase III trial. The decision follows […]

Photocure has reached agreement with BioSyent Pharma to reacquire the marketing and distribution rights to Cysview in Canada. The parties entered into a final agreement, stipulating that commercial rights will transfer to Photocure on January 1st, 2022. The reacquisition of marketing and distribution rights enables Photocure’s direct management of the Cysview brand in Canada and […]

Immunovia, Inc has received final approval to begin patient testing for the IMMray PanCan-d test. The IMMray PanCan-d test is the first blood test on the market dedicated to the early detection of pancreatic cancer. “We are extremely pleased to have achieved this important milestone and to be able to launch the first non-invasive, highly […]

Hansa Biopharma has announced that its treatment Idefirix is, as of August 1, reimbursable and available for use in the Netherlands. Idefirix is the first and only treatment approved for use in the European Union for desensitization of highly sensitized patients prior to kidney transplantation, allowing them to be considered for a life-altering kidney transplantation […]

AstraZeneca and HUTCHMED’s Orpathys has been granted conditional approval in China to treat patients with non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. This approval follows a priority review designation by the Center for Drug Evaluation of China’s National […]