The Food and Drug Administration has approved a new device for closing small holes in the heart called patent foramen ovales (PFO), which in some patients can be a cause of recurrent strokes. The non-surgical device can be inserted through a catheter in a vein in the leg.
A new medicine that is expected to protect against a rare liver disease known as primary biliary cholangitis, has been recommended for approval in the European Union following a Phase 3 study in which the treatment showed a clear benefit over placebo.
The European Medicines Agency has appealed against a court order preventing it from releasing documents relating to two marketed medicines, arguing that the disclosures are consistent with its policy on transparency.
The Food and Drug Administration has approved a new device for people with Type 1 diabetes – the first to automatically monitor blood glucose levels and release insulin at the appropriate dose. The so-called ‘artificial pancreas’ is intended to adjust insulin levels in the blood with little or no input from the user.
Rejecting the advice of its advisory committee, the Food and Drug Administration has approved the first drug for Duchenne muscular dystrophy, a rare disorder that causes a progressive deterioration in the muscles of people with a specific gene mutation.
The European Medicines Agency has recommended two new cancer drugs for marketing authorisation in the European Union, one of which is for the treatment of breast cancer and the other for soft tissue sarcoma.
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.