Business And Legal News In Brief
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
Since Congress is still tussling over a comprehensive patent reform bill, House Judiciary Committee Chairman John Conyers and Ranking Member Lamar Smith, R-Texas, introduced a stand-alone measure that would give the U.S. Patent and Trademark Office the authority to set its own fees for a 10-year period
Benlysta Back In The Spotlight With BLISS-76, But Second Phase III Still May Not Be Enough To Support Some Claims
BLISS-76 shows Benlysta 10 mg/kg is efficacious in patients with systemic lupus erythematosus; HGS/GSK expect to file in first half 2010.
Kyowa Hakko will work with U.S. FDA to determine a path forward for its Parkinson's treatment istradefylline (KW-6002) after receiving a "not approvable" letter from the agency Feb. 25, the Tokyo-based firm said Feb. 27