Regulation & Policy

At the request of the FDA, Pfizer Inc has suspended its clinical programme for tanezumab in chronic lower back pain and diabetic peripheral neuropathy. But studies will continue in areas of unmet medical need such as cancer pain.

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A majority of members of a joint US Food and Drug Administration advisory panel voted on 14 July 2010 to recommend that GlaxoSmithKline’s diabetes drug, Avandia (rosiglitazone), be kept on the market but they expressed concerns about cardiovascular risk.

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Merck Serono’s new small molecule drug for relapsing-remitting multiple sclerosis, which is an oral formulation of cladribine, has been approved for marketing in Russia, the first government agency to approve the oral disease-modifying therapy.

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The European Medicines Agency has announced a review of rosiglitazone-containing medicines for diabetes following new safety data. The review will decide whether or not the marketing authorisations of the drugs should be revoked, suspended or changed.

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Evotec starts Phase 2 depression study

The European Medicines Agency has issued a second warning about supply problems for the Genzyme Corp drug, Fabrazyme (agalsidase beta), for Fabry disease. It is recommending that, where possible, an alternative treatment be used.

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The European Medicines Agency is proposing a new method for calculating the fees  that it charges to industry for its services. The fee structure would be simplified, with fewer fees charged for applications for a marketing authorisation.

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The Pharming Group NV said that its recombinant human C1 inhibitor for hereditary angioedema, Rhucin, has received a positive opinion from the European Medicines Agency. This ends a three-year effort to gain regulatory approval for the drug.

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SkyePharma Plc said it is reviewing all of its options following a meeting with the US Food and Drug Administration during which the agency outlined the work that would be required to meet its approval criteria for Flutiform, an asthma drug.

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At the request of the US Food and Drug Administration, Pfizer Inc has suspended the clinical development programme for its investigational compound for osteoarthritis, tanezumab. The clinical hold follows reports of adverse events.