The European Medicines Agency is recommending a tightening of its guideline on first-in-human clinical trials to provide better protections for volunteers and a new approach to evaluating protocols that cover a number of different study parts.
The Food and Drug Administration has approved a field trial of a mosquito that has been genetically modified in order to reduce the population of Aedes aegypti mosquitoes in the environment that carry the Zika virus.
An established antiviral medicine that has been on the market in Europe since 2005 to treat people with HIV-1 is being recommended for disease prevention as well. Truvada, which contains the active substances emtricitabine and tenofovir disoproxil, has received a positive opinion from the European Medicines Agency for use as pre-exposure prophylaxis, together with safer sex practices.
A new drug for glaucoma developed by Nicox SA of France and licensed to a unit of Valeant Pharmaceuticals has been rejected by the US Food and Drug Administration because of deficiencies at the company’s Florida manufacturing plant.
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.