Regulation & Policy

Studies suggesting that use of the diabetes treatment, Lantus (insulin glargine), could be linked to cancer have been investigated by the European Medicines Agency which has concluded that the medicine is safe to prescribe.

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The European Commission has opened antitrust investigations against Servier, one of France’s largest pharmaceutical companies, and a number of generic manufacturers for suspected breaches of EU competition law. These are the first proceedings to be brought after its 18-month pharma industry probe.

Five new medicines, including a cell-based treatment for cartilage defects, have received positive opinions from the European Medicines Agency, paving the way for the issuing of marketing authorisations by the European Commission.

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The European Medicines Agency has recommended that a marketing authorisation be given to a cell-based, cartilage-repair treatment under the European Union’s Advanced Therapies Regulation, which came into effect at the end of 2008.

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The European Medicines Agency is inviting comments from industry and medical professionals on its proposal to make more regulatory documents public as well as to open up its own decision-making procedures to more outside scrutiny.

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The US Food and Drug Administration has asked Genmab A/S for an updated analysis of safety data for the monoclonal antibody, zalutumumab, which is being investigated for head and neck cancer.

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The European Medicines Agency has given positive opinions to three new drugs, two of which are intended for patients suffering from cancer. The agency also recommended new uses for three already approved drugs.

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Epigenomics AG has announced plans to work with the Munich Technical University and clinicians in Bavaria to test the viability of a blood-based biomarker for detecting precancerous lesions. The German government is helping to fund the project.

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GW Pharmaceuticals Plc has applied to regulatory authorities in the UK and Spain to have its cannabinoid pharmaceutical product approved for the treatment of spasticity due to multiple sclerosis. This follows positive results from a recent Phase 3 trial.

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Sepracor Pharmaceuticals Ltd, a subsidiary of Sepracor Inc of Marlborough, Mass., has withdrawn its marketing authorisation application for an insomnia drug from the EMEA because the regulator refused to recognise it as a new active substance.

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