The Japanese regulator has approved a rotavirus vaccine developed by GlaxoSmithKline Plc to prevent gastroenteritis caused by rotavirus in infants. The vaccine contains a live, attenuated form of the human rotavirus, RIX4414 strain.
Amsterdam Molecular Therapeutics Holding NV is to appeal against a negative opinion issued by the European Medicines Agency for its gene therapy to treat a protein deficiency linked to pancreatitis. The opinion was issued on 23 June 2011.
Nexium (esomeprazole magnesium), a treatment for acid-related conditions of the stomach, has received its first regulatory approval in Japan, according to AstraZeneca Plc, the drug’s developer. The approval is for use in adult patients.
A project aimed at developing tools to monitor the neurotoxic effects of environmental pollutants on developmental disorders in children has been funded by the European Commission under its 7th Framework programme for research.
An advisory panel to the US Food and Drug Administration has endorsed the agency’s decision in late 2010 to remove the breast cancer indication for Avastin (bevacizumab) despite strenuous objections from the drug’s manufacturer, Roche.
A new method for deriving induced pluripotent stem cells (iPSCs) from blood samples has been described in the journal, Blood. According to the authors, the approach could provide a new source of patient-specific cells for disease research and drug discovery.
Actelion Ltd, the Swiss specialist in treatments for pulmonary arterial hypertension (PAH), said it is making a provision of $577 million (CHF 485 million) for damages awarded by a jury in California.
A team of scientists has reported using a gene therapy technique known as genome editing to restore haemostasis in mice with haemophilia. The findings were reported online in the journal Nature on 26 June 2011.
The European Medicines Agency has issued a negative opinion to an application from Amsterdam Molecular Therapeutics BV for a gene therapy to treat patients with an enzyme deficiency that is linked with pancreatitis.
Boehringer Ingelheim GmbH’s new Type 2 diabetes drug, Trajenta (linagliptin) has received a positive opinion from the European Medicines Agency’s main scientific committee. This follows US Food and Drug Administration approval on 2 May.