Regulation & Policy

Up to 15% of applications for new medicines to the European Medicines Agency come from companies that employ fewer than 250 people and in 2015, three quarters of these applications were granted a marketing authorisation.

The European Medicines Agency is recommending that the Roche medicine Gazyvaro (obinutuzumab) be used to treat patients with follicular lymphoma, in addition to its approved indication for chronic lymphocytic leukaemia (CLL).

A review of the safety of Zydelig (idelalisib) as a combination cancer agent is ongoing, with a report expected to be made to the Committee for Medicinal Products for Human Use (CHMP) in June, according to the European Medicines Agency.

The first drug to target a specific protein in patients with chronic lymphocytic leukaemia has been approved by the US Food and Drug Administration. Venclexta (venetoclax) is designed to target the B-cell lymphoma 2 protein, which is overexpressed in many CLL patients.

A ruling by the Obama administration to further tighten rules against tax inversions has led to the termination of a pending $160 billion merger between Pfizer Inc and Allergan Plc. Meanwhile Shire Plc has said that its merger with Baxalta will go ahead.

Daratumumab has received a positive opinion from the European Medicines Agency, paving the way towards marketing approval for a treatment that has been shown to work in patients with multiple myeloma, an incurable blood cancer.

A new gene therapy developed by the San Raffaele Telethon Institute for Gene Therapy together with GlaxoSmithKline Plc, has been given a positive review by the European Medicines Agency. If approved by the European Commission, it will only be the second gene-based product to reach the market in the west.

In order to protect the safety of the US blood supply, the Food and Drug Administration has given clearance for the use of an experimental diagnostic developed by Roche to test blood donations for the Zika virus. While the test has not yet been formally approved, it is being allowed for use in screening.

The US Food and Drug Administration has approved a new drug for hepatic veno-occlusive disease, a rare and life-threatening liver condition that can be a complication of high-dose chemotherapy given before a bone marrow transplant.

The US Food and Drug Administration has asked Newron Pharmaceuticals SpA to provide more information on the potential for abuse of its candidate drug for Parkinson’s disease safinamide. The FDA is withholding approval pending further information.