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Regulation & Policy
Sweden to invest $320 million in life sciences
Thursday 13 September 2012
Sweden has announced plans to invest $320 million over four years in the life sciences of which one third will support new infrastructure for projects in translational medicine. The investment will be concentrated in the Stockholm-Uppsala region.
Location
Sweden
FDA approves Bosulif for chronic CML
Wednesday 5 September 2012
The US Food and Drug Administration has approved Bosulif (bosutinib) a new tyrosine kinase inhibitor from Pfizer Inc for the treatment chronic myelogenous leukaemia (CML) in patients who are resistant to other therapies including imatinib.
Location
United States
FDA approves Xtandi for prostate cancer
Sunday 2 September 2012
The US Food and Drug Administration has approved a new androgen receptor inhibitor, Xtandi (enzalutamide), for patients with late-stage castration-resistant prostate cancer who had previously been treated with docetaxel. Xtandi was given a priority review.
Location
United States
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
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Recent Appointments
Steffen Thirstrup joins NDA Group
Monday June 10 2013
Tarquin Bennett-Coles joins Odgers Berndtson
Monday June 10 2013
Sandy Eisen becomes non-executive director at Phosphate Therapeutics
Thursday June 6 2013
Eric-Paul Paques to chair Grünenthal
Thursday June 6 2013
Charles DeCarli joins advisory board at DiaGenic
Thursday June 6 2013