The European Medicines Agency has recommended that a marketing authorisation be given to a cell-based, cartilage-repair treatment under the European Union’s Advanced Therapies Regulation, which came into effect at the end of 2008.
The European Medicines Agency is inviting comments from industry and medical professionals on its proposal to make more regulatory documents public as well as to open up its own decision-making procedures to more outside scrutiny.
The US Food and Drug Administration has asked Genmab A/S for an updated analysis of safety data for the monoclonal antibody, zalutumumab, which is being investigated for head and neck cancer.
The European Medicines Agency has given positive opinions to three new drugs, two of which are intended for patients suffering from cancer. The agency also recommended new uses for three already approved drugs.
Epigenomics AG has announced plans to work with the Munich Technical University and clinicians in Bavaria to test the viability of a blood-based biomarker for detecting precancerous lesions. The German government is helping to fund the project.
GW Pharmaceuticals Plc has applied to regulatory authorities in the UK and Spain to have its cannabinoid pharmaceutical product approved for the treatment of spasticity due to multiple sclerosis. This follows positive results from a recent Phase 3 trial.
Sepracor Pharmaceuticals Ltd, a subsidiary of Sepracor Inc of Marlborough, Mass., has withdrawn its marketing authorisation application for an insomnia drug from the EMEA because the regulator refused to recognise it as a new active substance.
In successfully seeking regulatory approval for its first-in-man study of an embryonic stem cell treatment for spinal cord injury, Geron Corporation took great care to characterise all of its materials and processes.
The US National Institutes of Health is requesting comments on draft guidelines that will inform the use of embryonic stem cells in medical research. Comments are requested by 26 May 2009 to the NIH.
European health authorities have met with vaccine manufacturers to discuss a strategy for making vaccines available to the public should a flu pandemic be declared by the World Health Organisation.