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.
Merck & Co and Austria’s Intercell AG have announced the end of a Phase 2/3 clinical trial of a vaccine for the prevention of Staphylococcus aureus (S. aureus) infection. Trial enrolment had previously been suspended in April.
4SC AG has announced that a Phase 2b trial of its small molecule inhibitor of pro-inflammatory cytokines, vidofludimus, failed to meet its primary endpoint in a Phase 2b trial of patients with rheumatoid arthritis.
The European Medicines Agency and national regulators in the European Union member states are proposing to relax procedures regarding the protection of pharmaceutical data in order to put more information into the public domain.