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.
The European Medicines Agency has recommended that a new artemisinin-based combination therapy be approved to treat malaria in adults, children and infants aged six months or older. The agent combines dihydroartemisinin and piperaquine.
Ablynx NV is set to receive a €5 million milestone payment from Boehringer Ingelheim following the German company’s decision to progress an antibody-derived therapeutic protein for Alzheimer’s disease into late preclinical development.
The European Medicines Agency is recommending restrictions on the use of dexrazoxane, currently indicated for certain cancer patients, because of an increased risk of acute myeloid leukaemia and myelodysplastic syndrome.
Evotec AG and the Roche group have announced a three-year collaboration to discover biomarkers that could be used to predict the dosage and efficacy of targeted oncology drugs under development at the Swiss multinational.