GSK withdraws MAA for combination melanoma drug
GlaxoSmithKline Plc has withdrawn its marketing authorisation application in Europe for the combination melanoma treatment trametinib/dabrafenib.
Regulation & Policy
EMA highlights personalised medicine
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.
EMA launches adaptive licensing pilot
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.
Fast track designation for Actelion antibiotic
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.
FDA approves Myalept for rare disease
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.
Positive opinion for GSK’s Anoro
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).
EMA, FDA to collaborate on safety
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.
FDA supports novel design
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.
J&J to share anonymised clinical data
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.
Positive opinion for GSK diabetes drug
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.