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.
A novel immune mechanism that could play a role in the treatment of a wide variety of diseases has been described in the journal Science. The finding was made by a team led by Eric Vivier, scientific co-founder of Innate Pharma SA of France.
James Murdoch has decided to stand down from the board of directors of GlaxoSmithKline Plc at the company’s annual general meeting on 3 May 2012, GSK announced. Mr Murdoch is one of 12 non-executive directors of company.
Two papers in the Journal of Medicinal Chemistry have highlighted technology developed by scientists at Heptares Therapeutics Ltd aimed at generating new leads for drugs that target the G protein-coupled receptor (GPCR) family of proteins.