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Tysabri’s PML Risk Quantified In Revised Label; Can Added Certainty Add Scripts?

 
• By Martin Berman-Gorvine

Multiple sclerosis and Crohn’s disease patients with anti-JC virus antibodies who have previously taken other immunosuppressants have a 1.1% risk of developing the deadly neurological condition after taking Biogen Idec /Elan’s Tysabri for more than two years.

A first-ever quantification of the risks to multiple sclerosis and Crohn’s disease patients who take Biogen Inc. and Elan Corp. PLC’s Tysabri (natalizumab) of developing the deadly, incurable infection progressive multifocal leukoencephalopathy may, along with a newly approved diagnostic, help alleviate anxiety among patients and health care providers.

“We see the inclusion in the Tysabri label of the exact risk of developing PML while on Tysabri as a strong positive as it could even drive Tysabri use in...

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• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

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