Regulation & Policy

The European Medicines Agency is to extend its scientific advisory services to more companies in a more targeted fashion, under a new policy directed at experimental medicines that promise to meet a major public health need.

Briviact (brivaracetam), a new medicine for patients with epilepsy, has been approved by the US Food and Drug Administration. The drug was developed by UCB SA of Belgium.

The European Medicines Agency has set up a committee of experts with specialised knowledge of vaccines and infectious disease to contribute to the global response to Zika virus infection. Although not new, the virus has spread to Brazil where cases of neurological disorders have been reported.

The European Medicines Agency has given a positive opinion to a new immune-stimulating therapy for multiple myeloma using an accelerated procedure that is reserved for medicines addressing a major public health need.

The US Food and Drug Administration has approved the first drug to show a survival benefit in liposarcoma, a type of soft tissue sarcoma that is difficult to diagnose and treat. The drug, Halaven (eribulin mesylate), is a chemotherapy developed by Eisai Inc.

A volunteer in a Phase 1 trial of a novel neurological therapy, who had been declared brain dead three days ago, died on Sunday, according to the drug’s developer Bial-Portela & Ca. SA of Portugal. Five other patients who took part in the trial remained hospitalised.

A candidate drug for Duchenne muscular dystrophy, a genetic disorder that progressively weakens muscles in the body, has been turned down by the US Food and Drug Administration because of insufficient efficacy, according to the sponsor BioMarin Pharmaceutical Inc.

A product that is currently used to treat burns has now been approved in the US for certain diabetic foot ulcers. It is a matrix which consists of silicone, cow collagen and shark cartilage and is placed over the ulcer providing an environment for new skin and tissue to regenerate and heal the wound.

 A new lung cancer treatment for patients who have a specific tumour mutation has received a positive opinion in Europe. The drug, Tagrisso (osimertinib), was developed by AstraZeneca Plc.

It is not often that regulators, companies and investors meet in the same room, let alone discuss topics of mutual interest. But this was the setting for the fourth annual meeting of the industry group, European Biopharmaceutical Enterprises (EBE), and the European Medicines Agency (EMA) in London on 14 December.