Regulation & Policy

The US Food and Drug Administration has approved a third tablet therapy to treat a respiratory allergy in less than a month – Ragwitek developed by ALK-Abelló A/S of Denmark and partnered with Merck & Co Inc.

The US Food and Drug Administration has approved the second tablet therapy to treat hay fever in less than a month – this time an immunotherapy developed by ALK-Abelló A/S of Denmark, in partnership with Merck & Co Inc.

The US Food and Drug Administration has approved Tanzeum (albiglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist from GlaxoSmithKline Plc for Type 2 diabetes. The approval comes with a requirement for post-marketing studies.

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GlaxoSmithKline Plc has withdrawn its marketing authorisation application in Europe for the combination melanoma treatment trametinib/dabrafenib.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.