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Anti-NGF Drugs Clinical Holds Could Depend On What FDA Panel Thinks Of Standard Of Care

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Arthritis Advisory Committee will review troubling reports that the drugs, meant to relieve chronic pain from osteoarthritis and other diseases, may also destroy patients’ joints.

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Anti-NGF Trials Might Resume With Very Narrow Patient Populations

FDA’s Arthritis Advisory Committee suggests strictures that could be so strong as to discourage the resumption of clinical trials of Pfizer’s tanezumab, Regeneron’s REGN475 and Janssen’s fulranumab.

Anti-NGF Studies Face Major Redesign After Arthritis Advisory Cmte. Urges Resumed Testing

Pfizer’s tanezumab, Regeneron’s REGN475 and Janssen’s fulranumab could head back to the clinic soon, but will need radical protocol changes to protect patients from the emerging risk of joint destruction.

Anti-NGFs Advisory Committee Postponed As FDA Reviews New Information

The agency is assessing safety signals for the biologics, which are being developed for chronic pain.

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