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Expanded NIH Stem Cell Support Means Novel Drug Development Tools

Executive Summary

A new generation of specialized drug development tools based on human embryonic stem cells - and maybe down the road new regenerative therapies - got a boost with the release of the Obama administration's hESC research guidelines July 6

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Regulatory Updates, In Brief

FDA won't review Merck Serono's oral cladribine NDA: FDA refused to file the NDA for Merck Serono's oral multiple sclerosis drug cladribine, the firm announced Nov. 30. The application was filed in September by the company's U.S. subsidiary EMD Serono (1"The Pink Sheet" DAILY, Sept. 30, 2009). FDA granted the cladribine NDA fast track status based on the need for an oral therapy in the subset of MS patients with relapsing disease. Though Merck Serono was first to submit an NDA for an oral therapy for relapsing MS, it has not been the odds-on favorite for first approval (2IN VIVO, November 2009). At Windhover's FDA/CMS Summit Dec. 3, FDA Office of New Drugs Director John Jenkins spoke generally of the agency's refuse-to-file actions, noting that if industry wants FDA to meet PDUFA review dates, complete applications must be submitted (3The IN VIVO Blog, Dec. 3, 2009)

Regulatory Updates, In Brief

FDA won't review Merck Serono's oral cladribine NDA: FDA refused to file the NDA for Merck Serono's oral multiple sclerosis drug cladribine, the firm announced Nov. 30. The application was filed in September by the company's U.S. subsidiary EMD Serono (1"The Pink Sheet" DAILY, Sept. 30, 2009). FDA granted the cladribine NDA fast track status based on the need for an oral therapy in the subset of MS patients with relapsing disease. Though Merck Serono was first to submit an NDA for an oral therapy for relapsing MS, it has not been the odds-on favorite for first approval (2IN VIVO, November 2009). At Windhover's FDA/CMS Summit Dec. 3, FDA Office of New Drugs Director John Jenkins spoke generally of the agency's refuse-to-file actions, noting that if industry wants FDA to meet PDUFA review dates, complete applications must be submitted (3The IN VIVO Blog, Dec. 3, 2009)

NIH Public/Private Partnerships And Health Care Reform High On Director Collins' Agenda

Industry collaborations are crucial in bringing the "discoveries that are bursting around us" to bear on development of diagnostics, preventive strategies and therapeutics, Collins says; NIH will brainstorm with economists on the cost-effectiveness of medical research.

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