Drug Development Pharma - March 8, 2016
MedImmune receives fast track designation
AstraZeneca’s global biologics research and development arm, MedImmune, has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalised with Type A strain influenza. The FDA’s Fast Track programme is designed to expedite the development and review of drugs […]
Drug Development Pharma - March 1, 2016
Update on Genmab’s ofatumumab development
Genmab A/S has announced an update on development plans for ofatumumab in autoimmune indications focusing on relapsing multiple sclerosis following the transfer of the rights to ofatumumab in this disease area from GlaxoSmithKline (GSK) to Novartis at the end of 2015. Phase III studies are expected to be initiated by Novartis with the subcutaneous formulation […]
Drug Development Pharma - February 23, 2016
AZ’s Brilique approved in EU for extended treatment of patients with history of heart attack
AstraZeneca has announced that the European Commission has granted marketing authorisation for Brilique (ticagrelor) at a new 60mg dose for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event. Treatment may be started as continuation therapy after an initial […]
Drug Development Pharma - February 13, 2016
AZ’s Zurampic approved in the EU for patients with gout
AstraZeneca has announced that the European Commission has granted marketing authorisation for ZurampicTM (lesinurad) 200mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid (sUA) levels with an adequate dose of an XOI alone. Zurampic […]
Drug Development Pharma - February 5, 2016
Oasmia apply for marketing authorization
Oasmia Pharmaceutical has announced the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its lead cancer product Apealea (also known as Paclical). Apealea is a novel formulation of paclitaxel based on the patented excipient platform XR-17, which forms Cremophor®-free micellar nanoparticles with paclitaxel. The indication sought for Apealea is treatment […]
Drug Development Pharma - February 3, 2016
AZ granted market authorisation for TAGRISSO
The European Commission has granted conditional marketing authorisation for AstraZeneca’s TAGRISSO, 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). Osimertinib is indicated for patients with T790M mutation-positive NSCLC, irrespective of previous treatment with an EGFR tyrosine kinase […]
