A new radiopharmaceutical developed by Algeta ASA of Norway to treat men with prostate cancer that has spread to the bones has been approved by the US Food and Drug Administration. The product (radium-223) is an alpha-emitting nuclide.
The European Medicines Agency has announced plans to change its structure from August in order to respond to public demands for more pharmaceutical data and to give stronger support to industry in the research and development of new drugs.
The European Medicines Agency has been ordered not to release documents relating to marketing authorisation applications from AbbVie Inc and InterMune Inc pending a final judgement. This follows a legal challenge by the two US companies to the agency’s transparency policy.
The US Food and Drug Administration has approved a new drug from CSL Behring in Germany to reverse anticoagulation in adults with acute major bleeding. To date, plasma has been the only other approved treatment in the US for this condition.
The European Medicines Agency is recommending approval of a new advanced therapy medicinal product which is intended for the repair of cartilage defects. The product had been available in some EU countries, but now it will be widely traded.
The workload of the European Medicines Agency increased in many areas during 2012 but notable was an increase in services to small and medium-sized enterprises (SMEs).
The European Medicines Agency has announced an investigation into academic findings that suggest an increased risk of pancreatitis and pancreatic duct metaplasia in patients with Type 2 diabetes who take GLP-1 agonists and DPP-4 inhibitors.
GlaxoSmithKline Plc has had its application for a new influenza treatment turned back by the US Food and Drug Administration owing to an administrative matter. Announcing receipt of a ‘complete response letter,’ GSK said the matter has recently been resolved.
The Type-2 diabetes drug Trajenta (linagliptin) won’t be launched in Germany following a decision by the county’s reimbursement authority that it doesn’t provide any additional benefit compared with medicines already on the market.
The US Food and Drug Administration has approved the Roche group’s antibody-drug conjugate, trastuzumab emtansine, for HER2-positive metastatic breast cancer, ushering in a new drug class linking an antibody with a cytotoxic drug.