The US Food and Drug Administration has said it will review its regulatory guidelines and consult experts on clinical trial design in a renewed push to stimulate the development of new antibiotic drugs – a public health priority.
The European Medicines Agency’s CHMP is recommending that Avastin (bevacizumab) be given approval for use in combination with chemotherapy to treat women with recurrent, platinum-sensitive ovarian cancer.
In what is being described as the largest initiative of its kind, 10 large pharmaceutical companies have announced the setting up a non-profit organisation through which they will collaborate to accelerate and improve clinical research.
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.
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.
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.
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.