GlaxoSmithKline Plc has withdrawn an application from the European Medicines Agency to expand the use of its breast cancer drug, Tyverb (lapatinib), in combination with paclitaxel. Separately, it has applied to have the drug used with trastuzumab.
The US Food and Drug Administration is expected to raise the fees it charges the pharmaceutical industry and other companies for its services in order to pay for a proposed increase in its budget for the fiscal year starting on 1 October.
The US Food and Drug Administration has refused to approve a new indication for Novartis’s meningococcal vaccine, Menveo, which would have extended its use to infants and toddlers. The vaccine is already approved for older age groups.
The UK National Institute for Health and Clinical Excellence is considering expanding its programme of scientific advice to include medical device companies and possibly venture capitalists, Andrew Dillon, the chief executive, told a meeting in London.
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.
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.
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.