Follow-On Biologics Legislation Could Reach Senate Floor By Year End
This article was originally published in The Pink Sheet Daily
Executive Summary
Design of patent protection, exclusivity and interchangeability provisions remains potential roadblock.
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Follow-On Biologics Bill Clears Senate Cmte. With Stronger Language On Exclusivity Cap
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Genzyme Receives Complete Response, Warning Letters For Lumizyme
The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter
Genzyme Receives Complete Response, Warning Letters For Lumizyme
Despite receiving a “complete response” letter and manufacturing warning letter on the same day, Genzyme remains upbeat about the likelihood of approval for its 2,000L scale-up of Myozyme.