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.
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.