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.
The US Food and Drug Administration has turned down a proposed new indication for the anti-depressant Brintellix (vortioxetine) saying that more clinical data is required. Discovered by H. Lundbeck A/S, the drug was being assessed for cognitive dysfunction.
In keeping with the trend toward global drug development, regulatory consultancies from Sweden and the US have merged, creating a network of more than 1,000 experts with knowledge of medical technology, science and US and European regulatory procedures.
The US Food and Drug Administration is recommending that people who have been diagnosed with Zika virus infection be ineligible as donors of cell and tissue-based products for any medical or surgically based procedures.
The European Medicines Agency is to extend its scientific advisory services to more companies in a more targeted fashion, under a new policy directed at experimental medicines that promise to meet a major public health need.
Briviact (brivaracetam), a new medicine for patients with epilepsy, has been approved by the US Food and Drug Administration. The drug was developed by UCB SA of Belgium.
The European Medicines Agency has set up a committee of experts with specialised knowledge of vaccines and infectious disease to contribute to the global response to Zika virus infection. Although not new, the virus has spread to Brazil where cases of neurological disorders have been reported.