Path to approval proves rocky for copycat biodrugs
Article Abstract:
The biotechnology industry uses safety concern arguments to stall the approval of biogeneric drugs. The Food and Drug Administration finds it difficult to grant approvals since the size and complexity of the biological drugs combined with the many steps of stringent tests involved need large sums of money, added to the threat of rare and serious immune reactions.
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 2005
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A merger too far?
Article Abstract:
A New York-based firm Bristol-Myers Squibb has established itself as a successful specialty-drug deliverer and this might help it to remain independent. The merger negotiations between Sanofi-Aventis and Bristol-Myers Squibb could be revived once a key patent dispute involving both companies is settled.
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 2007
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