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Expanded IND Access: FDA Seems Resolved, Leaving Many Questions For Firms

Executive Summary

FDA seems set on implementing its proposed rules on patient access to investigational drugs despite industry-wide concern

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Shortage Could Cause Early Access To Developmental Gaucher Disease Drugs

Shire and Protalix BioTherapeutics' experimental Gaucher disease drugs could enter the market early to help offset likely treatment shortages created by manufacturing problems with the only enzyme replacement therapy currently approved for the orphan condition: Genzyme's Cerezyme

Shortage Could Cause Early Access To Developmental Gaucher Disease Drugs

Shire and Protalix BioTherapeutics' experimental Gaucher disease drugs could enter the market early to help offset likely treatment shortages created by manufacturing problems with the only enzyme replacement therapy currently approved for the orphan condition: Genzyme's Cerezyme

Shortage Could Cause Early Access To Developmental Gaucher Disease Drugs

Shire and Protalix BioTherapeutics' experimental Gaucher disease drugs could enter the market early to help offset likely treatment shortages created by manufacturing problems with the only enzyme replacement therapy currently approved for the orphan condition: Genzyme's Cerezyme

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