Regulation & Policy

Margrethe Vestager has been nominated for a second term as EU competition commissioner in a re-make of the union’s executive body that will see women take 13 out of the 27 top jobs and a 28-year old Lithuanian assume responsibility for the environment and oceans.

Over the past decade, the European Medicines Agency and the US Food and Drug Administration have stepped up their collaborations with the result that more than 90% of the marketing authorisation decisions made by the two organisations are aligned. This is the conclusion of an analysis conducted by the EMA and FDA, which compared outcomes on 107 new medicine applications between 2014 and 2016. While both agencies evaluate applications independently, they nevertheless are coming to many of the same conclusions.

A new antibiotic which has shown activity against pneumonia was cleared for marketing by the US Food and Drug Administration on 19 August. The safety and efficacy of Xenleta (lefamulin) were demonstrated in two clinical trials of 1,289 patients with community acquired bacterial pneumonia.

A second drug has been approved in the US for myelofibrosis, a rare bone marrow disorder that disrupts the body’s normal production of blood cells. The drug, Inrebic (fedratinib), has been authorised for primary myelofibrosis as well as secondary post-polycythemia vera or post-essential thrombocythemia disease.

The US Food and Drug Administration has approved a third cancer drug that targets a genetic driver of cancer, rather than a specific type of tumour. The drug, Rozlytrek (entrectinib), is directed at cancers with neurotrophic tyrosine receptor kinase (NTRK) gene fusions, a fault that can result in the activation of signalling pathways involved in the proliferation of a number of solid tumours. These fusions are known to occur in breast, colorectal, non-small cell lung, pancreatic and thyroid cancers, among others.

A new combination treatment for drug-resistant tuberculosis (TB) has been approved in the US and is under review at the European Medicines Agency. Developed by the Global Alliance for TB Drug Development Inc, it is only the third new drug approved for TB in more than 40 years, and the first to be produced by a not-for profit organisation.

Novartis has appointed Page Bouchard, an industry veteran, to the role of chief scientific officer at AveXis Inc, a subsidiary at the center of a controversy over data manipulation in relation to the recently approved gene therapy Zolgensma for spinal muscular atrophy (SMA). Dr Bouchard has been with Novartis for 10 years and will take over the roles of CSO and head of research and development at AveXis that were previously held by Brian Kaspar and Allan Kaspar.

Novartis has responded to a statement from the US Food and Drug Administration on 6 August in which the regulator raised the issue of manipulation of product testing data in the production process for Zolgensma, the recently approved gene therapy for spinal muscular atrophy.

The World Health Organization has added several cancer therapies to its Essential Medicines List in recognition of their contribution to extending the lives of patients with cancer. The list, which is updated every two years, is intended to guide health authorities on which medicines represent the best value for money based on their effectiveness.

Slovakia has been added to the group of European countries whose pharma manufacturing inspections systems are on par with those in the US, enabling the Food and Drug Administration to automatically recognise products produced in the country’s factories.