The European Medicines Agency has reaffirmed its decision not to recommend the gene therapy, Glybera, for marketing following an appeal from the developer, Amsterdam Molecular Therapeutics BV. This is the second gene therapy to be turned down by the EMA.
The European Medicines Agency has announced the start of a new review of the cardiovascular risks associated with the use of non-selective NSAIDs (non-steroidal anti-inflammatory drugs) which are used to treat pain and inflammation.
An experimental malaria vaccine developed by GlaxoSmithKline Plc has reduced the risk of malaria by half in African children between the ages of five and 17 months. The results have been published in the New England Journal of Medicine.
The European regulatory review of SkyePharma Plc’s asthma treatment, Flutiform, will take longer than originally anticipated due to a lack of complete consensus among the member states about the product, SkyePharma announced on 18 October.
The US Food and Drug Administration has approved Juvisync (sitagliptin and simvastatin) from Merck & Co, the first combination drug for Type 2 diabetes and high cholesterol to be put on the market as a single tablet.
The US Food and Drug Administration has approved the erectile dysfunction drug, Cialis (tadalafil), for benign prostatic hyperplasia (BPH), and for the treatment of both BPH and erectile dysfunction when the conditions occur simultaneously.
The Japanese regulatory authority has approved Faslodex (fulvestrant), an oestrogen receptor antagonist, for metastatic breast cancer which has recurred or progressed following prior endocrine therapy, according to the developer, AstraZeneca Plc.
The US Food and Drug Administration has approved the tumour necrosis factor blocker, Remicade (infliximab), for the treatment of ulcerative colitis in children older than six years who have had inadequate response to conventional therapy.
The US Food and Drug Administration has issued a ‘complete response letter’ to GlaxoSmithKline Plc, effectively rejecting its application to market a new combination vaccine for children against three types of bacteria.
Seven new medicines, including a new diabetes treatment, an antibiotic for C. difficile, two drugs for HIV, and combination treatments for hypertension, have received positive opinions from the European Medicines Agency.