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FDA releases draft guidance for biosimilars
BIO SmartBrief | Feb 10, 2012
The FDA issued draft guidance for the approval of biosimilar drugs. The proposal would require companies to submit data from laboratory and clinical studies showing that biosimilars are "highly similar" to the original drugs, and in some cases trials may not be required. BIO President and CEO Jim Greenwood welcomed the release. "We look forward to reviewing the drafts in detail to ensure that they comply with our key principles," he said. Bloomberg Businessweek (02/12) Pharma Letter (U.K.), The (subscription required) (02/10) Reuters (02/09)
Analysis: Drug R&D costs high compared to returns from products
BIO SmartBrief | Feb 15, 2012
Biosimilar guidance prompts reviews of patent protection
BIO SmartBrief | Feb 16, 2012
Planned pharma layoffs nearly doubled in January
BIO SmartBrief | Feb 13, 2012
FDA's proposed $4.5 billion budget heavily depends on industry fees
BIO SmartBrief | Feb 14, 2012
Texas board sets tentative rules for adult stem cells
BIO SmartBrief | Feb 13, 2012
Researchers develop gel that can heal bone fractures
BIO SmartBrief | Feb 10, 2012
Four rules for a successful grant proposal
BIO SmartBrief | Feb 13, 2012
HDL, triglyceride genetics play a role in type 2 diabetes
BIO SmartBrief | Feb 14, 2012
Can Wacky Employee Perks Help You Retain Your Staff?
BIO SmartBrief | Feb 13, 2012
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