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Regulation & Policy
FDA approves new HIV combination treatment
Tuesday 28 August 2012
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.
Location
United States
Lemtrada application turned back by FDA
Monday 27 August 2012
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.
Location
France
FDA approves new indication for Lucentis
Friday 10 August 2012
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).
Location
United States
FDA approves Zaltrap for colorectal cancer
Saturday 4 August 2012
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.
Location
United States
FDA panel recommends ocriplasmin
Friday 27 July 2012
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.
Location
United States
EMA recommends first gene therapy
Friday 20 July 2012
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.
Location
United Kingdom
Revised EU clinical trials legislation published
Tuesday 17 July 2012
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.
Location
Belgium
FDA approves first HIV prevention drug
Tuesday 17 July 2012
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.
Location
United States
Meeting Report: Spotlight on advanced therapies
Friday 13 July 2012
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.
Location
Ireland
GSK withdraws Tykerb application from the FDA
Thursday 12 July 2012
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.
Location
United Kingdom
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Recent Appointments
Pascale Witz to head strategic development at Sanofi
Monday May 6 2013
Srinivas Akkaraju joins Sofinnova Ventures
Monday May 6 2013
Vicente Anido nominated to Nicox board
Monday May 6 2013
Jeremy Farrar named director of the Wellcome Trust
Monday May 6 2013
Harry Kirsch becomes CFO at Novartis
Monday May 6 2013