The European Medicines Agency is recommending approval of a new hexavalent vaccine developed by Sanofi Pasteur that is designed to protect infants against diphtheria, tetanus, pertussis, Hepatitis B, poliomyelitis and Haemophilus influenzae type B (Hib).
The US regulatory review of Zealand Pharma A/S’s new drug for Type 2 diabetes, lixisenatide, is set to begin following the Food and Drug Administration’s acceptance of a registration file from the company’s partner, Sanofi SA. Lixisenatide is a GLP-1 receptor agonist.
The US Food and Drug Administration has approved a second indication for the Novartis immunosuppressant everolimus: to prevent organ rejection in adult liver transplant patients. The same indication was approved in Europe in late 2012.
The US Food and Drug Administration has granted priority review status to the prospective HIV/AIDS medicine, dolutegravir, which has been developed by ViiV Healthcare, a business venture among GSK, Pfizer Inc and Shionogi & Co.
The US Food and Drug Administration has granted ‘priority review’ status to the Algeta ASA investigational therapy for the treatment of castration-resistant prostate cancer patients with bone metastases. The product (radium-223) is an alpha-emitting nuclide.
The US Food and Drug Administration has turned down Novo Nordisk A/S’s application to market the long-acting insulin drugs, Tresiba and Ryzodeg, pending the supply of more data on cardiovascular risk. It has also cited the Danish company for manufacturing violations.
The US Food and Drug Administration has approved a new indication for the Novartis drug Exjade (deferasirox) to treat patients aged 10 years and older who have chronic iron overload resulting from a genetic blood disorder.
The European Medicines Agency’s main scientific committee has turned down an application from Santhera Pharmaceuticals of Switzerland to market a drug for Leber’s Hereditary Optic Neuropathy (LHON). LHON is an inherited disease involving the progressive loss of sight.
The US Food and Drug Administration has approved a new pooled human plasma product for the treatment of patients with blood clotting disorders. The product is manufactured by Octapharma AG of Vienna, Austria.
The European Medicines Agency is recommending the suspension of Tredaptive (laropiprant and nicotinic acid) from the European market following a study that showed the drug had insufficient clinical benefit and safety problems.