biologics
Regulations for Biosimilars
Lisa A. Haile and Kimberly K. Egan | Jun 1, 2012
As biologic drug patents begin to expire, generic versions will hit the market—but how will they be regulated?
Gene Therapy for Brain Disease
Jef Akst | May 16, 2012
Delivering a missing enzyme to the brains of paralyzed children with a rare, life-threatening neurological disease restores movement and builds muscle mass.
FDA Eases Sterility Requirements
Bob Grant | May 16, 2012
The US Food and Drug Administration has relaxed some of the rules governing how companies must test the sterility of materials used to make biologic drugs.
Size Matters to Industry
Edyta Zielinska | Apr 11, 2012
Large molecules are more likely to make it to market these days than small molecules, according to new reports.
FDA Discusses Biosimilars
Edyta Zielinska | Aug 8, 2011
The government says regulatory requirements for generic biological therapies will have to be tailored to the treatment in question.