Regulation & Policy

Gleevec given expanded indication for gastrointestinal cancer

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.

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Location

United States

FDA approves personalised therapy for cystic fibrosis

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.

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Location

United States

FDA approves Erivedge for skin cancer

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.

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Location

United States

Glybera marketing authorisation application in limbo

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.

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Location

Netherlands

FDA approves once-weekly drug for diabetes

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.

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Location

United States

FDA approves Inlyta for kidney cancer

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.

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Location

United States

FDA approves Sanofi plant

Sanofi SA has received FDA approval of its plant in Framingham, Massachusetts with the result that it can start restoring supplies of its treatment for Fabry disease. The FDA approval follows earlier approval by the European Medicines Agency.

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Location

France

FDA approves first test for risk of PML

The US Food and Drug Administration has approved the first diagnostic that will enable healthcare professionals to determine whether a patient taking the multiple sclerosis drug, Tysabri (natalizumab), faces a risk of the brain infection, PML.

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Location

United States

New drug for Cushing’s disease gets positive opinion

Novartis’s new treatment for Cushing’s disease, a rare hormonal disorder, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

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Location

United Kingdom

EMA announces safety review of Gilenya

The European Medicines Agency has announced the start of a safety review of the Novartis treatment for multiple sclerosis, Gilenya (fingolimod), less than a year after the drug was authorised for marketing in the European Union.

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Location

United Kingdom

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