The management of Amsterdam Molecular Therapeutics NV is proposing to de-list the company and transfer its gene therapy assets to a new private concern following a regulatory rejection of its lead product Glybera. Shareholders will vote on the proposal on 30 March.
The European Medicines agency has issued contraindications and warnings for aliskiren medicines which include the Novartis drug Rasilez. The drug shouldn’t be used in patients with diabetes or renal impairment who take ACE inhibitors.
The US Food and Drug Administration has approved the synthetic steroid, mifepristone (Korlym), as a treatment for adults with endogenous Cushing’s syndrome, a rare disease caused by the overproduction of cortisol. It is the first approved treatment for this condition.
GlaxoSmithKline Plc has withdrawn an application from the European Medicines Agency to expand the use of its breast cancer drug, Tyverb (lapatinib), in combination with paclitaxel.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.