New Market - December 20, 2021
AstraZeneca’s Tezspire approved in the US
AstraZeneca and Amgen’s Tezspire has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma. Tezspire was approved following a Priority Reviewby the US Food and Drug Administration (FDA) and based on results from the PATHFINDER clinical trial programme. The application included […]
Biotech Business - December 16, 2021
FDA approves Calliditas’ TARPEYO
Calliditas Therapeutics has announced that the US Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. This indication is approved under accelerated approval. It has not been established […]
New Market - September 28, 2021
AstraZeneca’s Saphnelo approved in Japan for SLE
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 […]
New Market - September 1, 2021
AstraZeneca’s Forxiga approved in Japan
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 […]
MedTech Business - August 31, 2021
Photocure regains rights to Cysview in Canada
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 […]
MedTech Business - August 4, 2021
Immunovia Inc to begin patient testing in the US
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 […]
