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Search results for: biologics

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Articles results:

Governors, Lawmakers Pressure FDA To Ease Market Entry Of Generic Insulin
Some federal lawmakers and governors have been lobbying FDA to ease the way for the production and sale of generic insulin, which analysts say would reduce the cost of diabetes treatment by 25%, the New York Times reports.

Best Practices For Parenterals: From Formulation To Manufacturing
AAPS workshop hosts experts at intensive six-day January retreatWHAT: The AAPS 42nd Annual Pharmaceutical Technologies Arden Conference Best Practices for Parenteral Dosage Forms: Formulation and Process Development, Package Selection, and Manufacturing will update scientists on the latest technologies for developing parenteral dosage forms for both small molecules and biologics.

Legislation Introduced In House And Senate That Would Give FDA Authority To Approve Generic Versions Of Biotechnology Drugs
Lawmakers in the House and Senate on Wednesday introduced a bill that would allow FDA to approve generic versions of biotechnology medications, USA Today reports (Schmit, USA Today, 2/15). According to the St.

TOP Classes Of Biologics With 2006 Sales Of US$ 63.8 Bln
The Business Intelligence firm La Merie S.L. reported today that the major cancer antibodies Rituxan, Herceptin, Avastin and Erbitux represent the no. 2 class of top selling biologics with the hightest growth rate of 57 % and combined 2006 sales of US$ 10.6 bln. In contrast, the class of erythropoietin products still had the highest sales in 2006 with US$ 11.9 bln, buth with the lowest growth rate (6.

GPhA Rebuttal On Dr. Siegel's Comments At Hearing
At the March 8, 2007 hearing before the Senate Health, Education, Labor and PensionsCommittee, Dr. Jay Siegel made some statements which merit a response to set the recordstraight. Siegel Statement: "there will always be a need for appropriate pre-marketing clinicaldata to ensure that a follow-on biologic is safe and effective"-- Siegel sees the need for pre-marketing clinical data for generics, but not forbrands.

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