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image: Regulations for Biosimilars

Regulations for Biosimilars

By | June 1, 2012

As biologic drug patents begin to expire, generic versions will hit the market—but how will they be regulated?


image: Gene Therapy for Brain Disease

Gene Therapy for Brain Disease

By | 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.


image: FDA Eases Sterility Requirements

FDA Eases Sterility Requirements

By | 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.

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image: Size Matters to Industry

Size Matters to Industry

By | April 11, 2012

Large molecules are more likely to make it to market these days than small molecules, according to new reports.


image: FDA Discusses Biosimilars

FDA Discusses Biosimilars

By | August 8, 2011

The government says regulatory requirements for generic biological therapies will have to be tailored to the treatment in question.


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