An advisory panel of the US Food and Drug Administration has recommended that Afinitor (everolimus) be approved for patients with advanced neuroendocrine tumours of pancreatic origin, according to Novartis, the drug’s developer.
The US Food and Drug Administration has approved gabapentin enacarbil for the treatment of restless legs syndrome in adults. The drug was developed by XenoPort Inc of the US. GlaxoSmithKline Plc is a commercial partner.
The US Food and Drug Administration has announced the approval of vandetanib from AstraZeneca Plc for the treatment of patients with late-stage medullary thyroid cancer who are ineligible for surgery. The decision was announced on 6 April.
Reliance GeneMedix Plc, which is part of the Reliance Life Sciences Group in India, has withdrawn a marketing authorisation application for erythropoietin from the European Medicines Agency. It cited its inability to supply additional data.
It is something of a truism to say that money follows success. It is less easy to say why some companies are more successful than others, and how their successes can be repeated.
The US Food and Drug Administration has approved a new monoclonal antibody, Yervoy (ipilimumab), to treat patients with late-stage melanoma, the most dangerous type of skin cancer. The antibody is manufactured by Bristol-Myers Squibb Inc.
GlaxoSmithKline Plc said it is withdrawing its regulatory applications for dutasteride (Avodart) which was being investigated to reduce the risk of prostate cancer in men at an increased risk of the disease.
The European Medicines Agency has launched an online registry which, for the first time, gives the public access to information on interventional clinical trials in the European Union that heretofore has only been available to the regulatory authorities in the member states.
The European Medicines Agency’s management board has taken the unusual step of reminding its former executive director, Thomas Lönngren, of restrictions that apply to his professional activities for two years following his departure.
The European Medicine Agency’s main scientific committee has started safety reviews of three marketed medicines following reports of adverse events. The medicines are Revlimid, Vivaglobin and pioglitazone-containing drugs.