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.
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.