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Tysabri Long-Term Users Must Provide Additional Consent In Europe

This article was originally published in The Pink Sheet Daily

Executive Summary

A three-month EMEA safety review confirms that two years of treatment with the monoclonal antibody increases the risk for PML.

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Regulatory Updates, In Brief

Labopharm's once-daily trazodone gets regulatory nod: FDA cleared Oleptro, Labopharm's once-daily formulation of the antidepressant trazodone, for treatment of major depressive disorder in adults Feb. 3. Commercialization plans for the extended release tablets appear to rest on when the specialty pharma confirms a marketing partner for the therapy. Labopharm said it is actively exploring alternatives that range from out-licensing to a distribution agreement under which it would retain some degree of co-promotion rights, to a full co-promotion arrangement under which the company would share sales functions with a partner. Labopharm has completed market research with physicians and third-party payers, developed a positioning and marketing campaign and finalized manufacturing and packaging arrangements, so it would appear it is readying Oleptro to be a turn-key opportunity. Oleptro should be available later this year, with a launch to be determined by the final commercialization plan

Regulatory Updates, In Brief

Labopharm's once-daily trazodone gets regulatory nod: FDA cleared Oleptro, Labopharm's once-daily formulation of the antidepressant trazodone, for treatment of major depressive disorder in adults Feb. 3. Commercialization plans for the extended release tablets appear to rest on when the specialty pharma confirms a marketing partner for the therapy. Labopharm said it is actively exploring alternatives that range from out-licensing to a distribution agreement under which it would retain some degree of co-promotion rights, to a full co-promotion arrangement under which the company would share sales functions with a partner. Labopharm has completed market research with physicians and third-party payers, developed a positioning and marketing campaign and finalized manufacturing and packaging arrangements, so it would appear it is readying Oleptro to be a turn-key opportunity. Oleptro should be available later this year, with a launch to be determined by the final commercialization plan

Tysabri Risk Communication Goes Beyond REMS With Monthly Update For Docs

Biogen Idec's decision to start providing doctors with monthly updates on progressive multifocal leukoencephalopathy cases among Tysabri patients shows the firm's confidence that providing additional risk information will not discourage use of the product

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