Regulation & Policy

The Food and Drug Administration has given an insight into its attitude toward novel trial designs in a commentary written by Commissioner Margaret Hamburg and published online on 6 February.

Janssen Research and Development LLC is to allow healthcare professionals and researchers access to anonymised data from its clinical trials, under an agreement negotiated with the Yale School of Medicine in the US.

The European Medicines Agency’s main scientific committee has given a positive opinion to a new drug developed by GlaxoSmithKline Plc for people with Type 2 diabetes. The drug, albiglutide, is a glucagon-like peptide-1 receptor agonist.

The US Food and Drug Administration has given an accelerated approval for a new treatment for metastatic melanoma that combines two licenced GlaxoSmithKline Plc medicines which block signalling in different sites of the same molecular pathway.

The US Food and Drug Administration has issued a complete response letter (CRL) to Sanofi SA saying it can’t approve the company’s supplemental Biologics License Application for Lemtrada (alemtuzumab) for relapsing multiple sclerosis.

Europe’s political leaders have reached an agreement on a new set of rules for conducting clinical trials in the EU. A key feature of the new legislation will be the introduction of a single authorisation procedure for all trials instead of multiple procedures at present.

The European Medicines Agency is recommending that Sirturo (bedaquiline) be granted a conditional market authorisation for pulmonary multidrug-resistant tuberculosis as part of a combination therapy. The new drug has been developed by Janssen Therapeutics.

The US Food and Drug Administration has approved Anoro Ellipta, a new medicine for chronic obstructive pulmonary disease (COPD) developed by GlaxoSmithKline Plc. It is the second COPD medicine from GSK to receive US approval this year.

The US Food and Drug Administration is tightening the oversight of antibiotics for the treatment of diseases in animals, and is calling on animal pharmaceutical companies to voluntarily stop their use as growth enhancers.

The US Food and Drug Administration has approved a second new drug in two weeks to treat chronic hepatitis C virus infection – Sovaldi (sofosbuvir) from Gilead Sciences Inc. Sovaldi is the first drug for certain HCV genotypes that won’t need co-treatment with interferon.