Regulation & Policy

The European Medicines Agency has given positive opinions to two new combination drugs to treat chronic hepatitis C virus (HCV) infection, both of which directly target proteins that cause the virus to replicate in humans.

AstraZeneca Plc has received a complete response letter (CRL) from the US Food and Drug Administration rejecting its application to market a new drug for hyperkalaemia called ZS-9. The CRL relates to an unspecified manufacturing issue.

The US Food and Drug Administration has approved a checkpoint antibody developed by Roche, Tecentriq (atezolizumab), to treat bladder cancer. It is the first product in its class to treat this type of cancer, inhibiting the PD-L1 pathway thereby enabling the body’s immune system to fight cancer cells.

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.