The US Food and Drug Administration has put a clinical hold on a Phase 2 trial of a new immunotherapy developed by Juno Therapeutics Inc after two patients died in early July. A third patient had previously died at the end of May.
Italy-based MolMed SpA has become the seventh company to get a positive recommendation from the European regulator to market an advanced therapy medicinal product, a group that includes cell and gene therapies as well as tissue-engineered products.
The European Medicines Agency has agreed to give an accelerated review of a gene therapy being developed by Kite Pharma Inc that promises to improve the standard of care for patients with diffuse large B-cell lymphoma (DLBCL), a type of blood cancer.
The European Medicines Agency has launched a review of guidelines for the testing of new medicines in volunteers following the death of one person and the hospitalisation of five others in France in January. The case is the most serious incident to come to light since 2006 when an experimental immunotherapy seriously injured six volunteers in a first-in-human study the UK.
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.