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EMA Adopts Final Guideline on Biosimilarity Clinical Considerations
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Celgene Unable to Dismiss Lawsuit in First Written REMS Opinion
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FDA Panel Signs Off on Sandoz’s Biosimilar Application on Neupogen
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Industry Wants More Drugs Eligible for ‘First Generic’ Status
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Par Wins Reprieve From Appeals Court in Patent Fight to Protect AIDS Drug
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Industry Expresses Trepidations With Proposed Pill Change Survey
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GPhA, Health Groups Argue Leaked TPP Draft Hinders Generic Competition
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Actavis Barred From Pulling Older Namenda Formulation
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EFPIA Proposes Process to Facilitate Early Resolution of Patent Disputes
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Jury Favors AstraZeneca and Ranbaxy in Nexium Pay-for-Delay Case
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FDA Seeks to Help Generics Obtain REMS-Protected Product Samples
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OGD to Focus on Approvals in Addressing ANDA Backlog
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