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Business And Legal News In Brief

Executive Summary

Positive top-line results for Roche's CellCept: Roche and Vifor Pharma announced June 3 that CellCept (mycophenolate mofetil) demonstrated superiority to azathioprine (AZA) in delaying treatment failure in patients with lupus nephritis during the maintenance phase of the Aspreva Lupus Management Study, one of the largest ever conducted in lupis nephritis. Vifor Pharma will report full results at the International Congress on Systemic Lupus Erythematosus June 24-27. Late last year, positive data from a second Phase III trial of Human Genome Sciences/GlaxoSmithKline's lupus candidate Benlysta generated attention, but FDA has not approved a new treatment for the disease in more than 50 years, leaving stakeholders awaiting the next market entrant (1"The Pink Sheet" DAILY, Nov. 2, 2009)

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Patent Office Would Get Ability To Set Fees Under House Bill; PTO To Allow Applicants To Fast Track One Application By Dropping Another

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Benlysta Back In The Spotlight With BLISS-76, But Second Phase III Still May Not Be Enough To Support Some Claims

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Kyowa Hakko’s Parkinson’s Drug Is Not Approvable – U.S. FDA

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