The US Food and Drug Administration has approved Nulojix (belatacept), a new treatment to prevent organ rejection in adult patients who have had a kidney transplant. The developer is Bristol-Myers Squibb Company.
Immatics Biotechnologies GmbH of Tübingen, Germany has started vaccination of the first patients in a Phase 3 trial of its therapeutic vaccine for renal cell cancer. The primary endpoint is overall survival in combination with sunitinib.
The European Union’s public-private partnership for drug development research, the Innovative Medicines Initiative, is to formally collaborate with the US Critical Path Institute, in a move to share more information from pre-competitive research.
The US Food and Drug Administration has approved a new genetic test that will help physicians to determine if women with human epidermal growth factor Receptor 2-positive (HER2+) breast cancer can benefit from Herceptin (trastuzumab).
The current shortage of new antibiotic medicines is to be the subject of talks between the European pharmaceutical industry federation (Efpia) and the European Commission as concern mounts about a rise in antimicrobial resistance.
The US Food and Drug Administration has approved ezogabine, a potassium channel opener, as an adjunctive treatment for partial-onset seizures in patients 18 years and older. The developers are Valeant Pharmaceuticals and GSK.
The US Food and Drug Administration has approved a new imaging device that enables the simultaneous administration of a positron emission tomography scan (PET) and a magnetic resonance imaging scan (MRI). The device has been developed by Siemens.
The European Medicines Agency’s management board has taken steps to strengthen its conflict-of- interest rules for staff following a controversy involving its former executive director who became a consultant after leaving the agency.
Guido Rasi, head of the Italian Medicines Agency, has been nominated to become the new executive director of the European Medicines Agency, following the departure of Thomas Lönngren who completed two terms on 31 December 2010.
Pfizer Inc has received institutional review board approval to start a virtual clinical trial in the US that uses mobile telephone and web-based technology to collect data from participants rather than requiring them to visit clinics.