Drug Development Pharma - March 7, 2017
Sobi receives FDA approval for Orfadin capsules
Swedish Orphan Biovitrum announces that FDA has approved in-use storage at room temperature (25°C or less) for up to 45 days for all strengths of Orfadin capsules. The FDA approval follows the already existing approval by the European Medicines Agency (EMA) for in-use storage at room temperature. In addition to this, FDA also approved an […]
Drug Development Pharma - March 2, 2017
Sobi receives approval from the EMA
Swedish Orphan Biovitrum has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K Variation for Elocta (efmoroctocog alfa). The variation involves several changes, including the approval of Elocta drug substance manufacturing in 15 000 litre scale bioreactors. Elocta is a recombinant extended half-life factor VIII Fc fusion protein product for […]
Drug Development Pharma - February 28, 2017
FDA approves once-daily Qtern tablets for adults with type-2 diabetes
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. The new medicine is indicated as an adjunct to diet and exercise to improve glycaemic (blood sugar level) control in adults with type-2 diabetes who have inadequate control with […]
Drug Development Pharma - February 17, 2017
AZ’s Siliq approved by the FDA
AstraZeneca’s partner Valeant Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved Siliq (brodalumab) injection for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Siliq is an IL-17 receptor […]
Drug Development Pharma - February 15, 2017
Denmark bids to host EMA headquarters in Copenhagen
Last week, the Danish Government officially announced its candidacy for hosting the European Medicines Agency (EMA) in Denmark. ”The Danish Medicines Agency is excited about the Danish Government’s decision. The EMA is the most important European coordination forum in the pharmaceutical field, and Copenhagen offers a visionary and innovative life science cluster. Major international pharmaceutical […]
Drug development - December 7, 2016
Swedish drug development on the rise
Earlier today, SwedenBIO presented its annual report on the Swedish drug discovery and development pipeline, showing for example that the number of clinical stage drug development projects has increased from 63 to 144 in 5 years. The report provides facts and figures about the current Swedish drug development pipeline for drugs intended for use in […]
