The US Food and Drug Administration has approved a new medical device that gives patients with small arteries the option of less invasive surgery to repair abdominal aortic aneurysms. The device is manufactured by TriVascular Inc of California.
Eli Lilly and Company has announced the withdrawal of its treatment for septic shock, Xigris, from all markets following a new clinical study that failed to show efficacy. The study did not throw up any new safety findings.
The US Food and Drug Administration has approved Onfi (clobazam) from H. Lundbeck A/S as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome. The approval is for adults and children aged two years and older.
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.