Biotech Business - May 13, 2022
Hansa Biopharma announces temporary marketing authorization in Switzerland
Hansa Biopharma has announces that the Swiss Agency for Therapeutic Products (Swissmedic) has granted temporary marketing authorization for Idefirix in adult patients with a positive crossmatch against an available organ from a diseased donor. The use of Idefirix in Switzerland is reserved for patients with a low probability of being transplanted within the framework of […]
New Market - April 4, 2022
Novo Nordisk’s Ozempic 2.0 mg approved in the US
Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved a 2.0 mg dose of Ozempic (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analogue for the treatment of adults with type 2 diabetes. Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the […]
New Market - April 1, 2022
InDex Pharmaceuticals prepares for commercialization of cobitolimod
InDex Pharmaceuticals Holding is planning for self-commercialization of the drug candidate cobitolimod in the US with strategic collaborations in other regions. Launch is expected in 2027, with the potential for annual sales to reach more than USD 1 billion, in moderate to severe left-sided ulcerative colitis, states the company. Read more: Hey there Peter Zerhouni, […]
New Market - March 29, 2022
AstraZeneca’s Ondexxya approved in Japan
Ondexxya has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ANNEXA-4 Phase III clinical trial showing […]
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 […]
