The US Food and Drug Administration has approved a new once-daily combination tablet for HIV-1 infection in treatment-naïve adults that contains two previously approved HIV drugs plus two new ones, providing a complete treatment regime.
The US Food and Drug Administration has told Genzyme (Sanofi SA) to re-do its marketing authorization application for Lemtrada (alemtuzumab) for MS to change the presentation of the data. No additional data is being requested, Sanofi said.
The US Food and Drug Administration has approved Lucentis (ranibizumab injection) for the new indication of diabetic macular edema, an eye disease that can occur in people with diabetes. The developer is Genentech (Roche).
The US Food and Drug Administration has approved a new angiogenesis inhibitor, Zaltrap (ziv-aflibercept), for the treatment of metastatic colorectal cancer in combination with chemotherapy. Regeneron Pharmaceuticals Inc and Sanofi SA are co-developers.
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GlaxoSmithKline Plc announced that it has withdrawn an application from the US Food and Drug Administration for a new indication for its marketed cancer drug, Tykerb (lapatinib), a kinase inhibitor.