The US Food and Drug Administration has given the Novartis vaccine Bexsero, which is designed to protect against infection from meningococcal disease caused by serogroup B, a designation as a ‘breakthrough therapy’. This means it will receive an expedited review.
The US Food and Drug Administration has approved the first sublingual allergen extract for the treatment of hay fever which is induced by certain grass pollens. The product, Oralair, was developed by Stallergenes SA of France.
The US Food and Drug Administration has approved a new medicine for haemophilia B – the first treatment for the disorder to require less frequent injections. The drug, Alprolix, was developed by Biogen Idec Inc and Swedish Orphan Biovitrum AB.
GlaxoSmithKline Plc has withdrawn its marketing authorisation application in Europe for the combination melanoma treatment trametinib/dabrafenib.
A new medicine and two imaging agents have been recommended for marketing in Europe under the European Union’s conditional licensing procedure – a procedure that enables medicines to reach patients on the basis of a limited data package.
The European Medicines Agency is inviting pharmaceutical companies to participate in a pilot project under which it will evaluate ‘adaptive licensing’ as a way of getting new medicines to patients earlier, under certain controlled situations.
Actelion Ltd’s investigational antibiotic for the treatment of Clostridium difficule-associated diarrhoea has been singled out for a ‘fast track’ designation by the US Food and Drug Administration because of its potential to improve public health.
The US Food and Drug Administration has approved a new hormone replacement therapy for the treatment of complications of leptin deficiency, the first approved therapy for the disease. Myalept (metreleptin) was developed by Amylin Pharmaceuticals LLC.
The European Medicines Agency’s main scientific committee has issued a positive opinion for a new GlaxoSmithKline Plc medicine to treat chronic obstructive pulmonary disease (COPD).
The European Medicines Agency and the Food and Drug Administration have stepped up their bilateral discussions about common regulatory issues to include monthly teleconferences on drug safety.