An advisory committee of the US Food and Drug Administration has backed a new ophthamic medicine, ocriplasmin, from ThromboGenics NV of Belgium saying it should be granted approval to treat an eye disease known as symptomatic vitreomacular adhesion.
After more than two years of deliberations, the European Medicines Agency has decided to recommend approval of the first ever gene therapy. The treatment, Glybera, is indicated for the treatment of patients with a rare inherited enzyme disorder.
The European Commission has released its long-awaited revisions to the EU Clinical Trials Directive recommending that the procedures for getting approval for multi-state clinical trials be simplified and the supervision of trials strengthened.
The US Food and Drug Administration has approved a new use for the Gilead Sciences, Inc antiretroviral drug, Truvada (emtricitabine and tenofovir disoproxil fumarate), for use in individuals who are at high risk of HIV infection.
Some 300 clinical trials are underway in Europe testing prospective cell, gene and tissue-engineered therapies. Known as advanced therapy medicinal products (ATMPs), these medicines are being investigated for a broad range of diseases- from macular degeneration to Parkinson’s disease.
GlaxoSmithKline Plc announced that it has withdrawn an application from the US Food and Drug Administration for a new indication for its marketed cancer drug, Tykerb (lapatinib), a kinase inhibitor.
The US Food and Drug Administration has approved the first genetic test that will detect whether patients with colorectal cancer are eligible for treatment with the antibody drug, Erbitux (cetuximab). The test was developed by Qiagen NV.
The US Food and Drug Administration has approved the first DNA test to help healthcare professionals evaluate the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.
The US Food and Drug Administration has approved the first over-the-counter, self-administered test to detect the presence of antibodies to the human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2).
GlaxoSmithKline Plc said that it will pay $3 billion to settle several criminal and civil cases brought against it by the US government, several states and the District of Columbia relating to past sales and marketing practices, including sales of Avandia.