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Amgen Ends Praecis Plenaxis Collaboration After FDA Requests More Studies

Executive Summary

Praecis is planning additional studies on the prostate cancer treatment Plenaxis (abarelix) to evaluate switching non-responders to alternate therapies.

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Praecis Plenaxis user fee date

FDA extends Praecis Plenaxis (abarelix) user fee date of Aug. 27 by 90 days during July 18 conference call with the company. "The agency has indicated that the company's proposed risk management program would need to include some form of controlled or managed distribution," Praecis says July 21. FDA raised concerns about the prostate cancer product's safety and efficacy in a June 2001 "not approvable" letter (1"The Pink Sheet" Sept. 24, 2001, p. 22)...

Praecis Plenaxis user fee date

FDA extends Praecis Plenaxis (abarelix) user fee date of Aug. 27 by 90 days during July 18 conference call with the company. "The agency has indicated that the company's proposed risk management program would need to include some form of controlled or managed distribution," Praecis says July 21. FDA raised concerns about the prostate cancer product's safety and efficacy in a June 2001 "not approvable" letter (1"The Pink Sheet" Sept. 24, 2001, p. 22)...

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