The US Food and Drug Administration has approved an expansion of the approved use of Gleevec (imatinib) to increase the time during which the drug is effective in patients with CD117-positive gastrointestinal stromal tumours (GIST). The developer of the drug is Novartis.
The US Food and Drug Administration has approved a new personalised medicine, Kalydeco (ivacaftor), for a rare form of cystic fibrosis, the first treatment to target a mutation in the cystic fibrosis transmembrane regulator (CFTR) gene.
Venture-capital backed Domain Therapeutics SA of France has received a grant from the Michael J. Fox Foundation to develop allosteric modulators for Parkinson’s disease. This follows a year-earlier licensing deal with Merck Serono, also for PD.
The US Food and Drug Administration has approved a skin cancer drug from Roche, Erivedge (vismodegib), its first ever approval of a treatment for metastatic basal cell carcinoma. Erivedge works by inhibiting the Hedgehog pathway.
In an apparently unprecedented situation, a committee of the European Union member states which advises the European Commission on the granting or refusal of marketing authorisations, has reached an impasse over the gene therapy, Glybera.
After two earlier rejections, a once-weekly treatment for type 2 diabetes, Bydureon (exenatide extended-release), has received clearance from the US Food and Drug Administration. The sponsors are Amylin Pharmaceuticals Inc and Alkermes Plc.
Transgene SA of France has further advanced its strategy for penetrating the market for biopharmaceuticals in China with the setting up of a wholly-owned subsidiary in Shanghai that will conduct early-stage research and development.
The US Food and Drug Administration has approved Inlyta (axitinib) for the treatment of advanced renal cell carcinoma, the seventh drug to be authorised for this indication since 2005, the agency said. The developer is Pfizer Inc.
The first embryonic stem-cell derived therapy for the eye has been safely transplanted into two patients with no signs of inflammation, rejection or tumourigenicity, according to a report published online in The Lancet on 24 January 2012.
A research consortium, led by investigators at St George’s, University of London, has reported discovering a new gene, the fourth in a series, to be associated with lymphoedema, a swelling that arises from an impaired lymphatic system.