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Orion Corporation has signed a European wide marketing and distribution agreement with Marinus Pharmaceuticals for ganaxolone, a GABAA receptor modulator being investigated in multiple rare seizure disorders. Under the terms of the agreement, Orion will have the right to sell and market ganaxoAlready a subscriber Login You have read all your free articles,…
AstraZeneca announces that on 25 January 2017 the US Food and Drug Administration (FDA) granted six months of paediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol. The FDA’s decision was based on the evaluation of trials conducted in children with asthma aged six up tAlready a subscriber Login You have read…
Oncopeptides has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the phase 2 HORIZON study in relapsed refractory multiple myeloma. Pending a positive validation from the EMA, melflufeAlready a subscriber Login You have read all your…
The European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-2 diabetes (T2D). The approval is based on data from five Phase III trials which evaluated combinations of ForxigaAlready a subscriber Login You have read all your free articles, to…
