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Long-awaited Enrichment Studies Guidance Released

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FDA posts a long-awaited draft guidance on clinical trial enrichment strategies that can be used in studies to support effectivene...

FDA Clears Insulet OmniPod Insulin System

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FDA clears an Insulet Corp. 510(k) for the OmniPod Insulin Management System.

Panel to Discuss GSK Breo Ellipta for COPD

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Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 3/7/13 to discuss a GlaxoSmithKline NDA for the...

Researchers ID Potential Drug Combos for Melanoma

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Yale University of Medicine researchers develop a new screening approach to evaluate cancer drugs in combination with other drugs ...

Appeals Court Finds Crestor Patent Valid

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The Federal Circuit Court of Appeals rules that a substance patent protecting AstraZenecas Crestor is valid and enforceable.

Novartis Orphan Drug Signifor OKd for Cushing's Disease

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FDA approved Novartis Pharma Stein AGs Signifor for Cushings disease patients who cant be helped through surgery.

Guidance Out on Design Considerations for Home Use Devices

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Federal Register Notice: FDA releases a draft guidance, Design Considerations for Devices Intended for Home Use.

Jail Terms Needed in Health Fraud Cases, Blumberg Says

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FDA deputy chief counsel for litigation Eric Blumberg calls for greater use of the Park Doctrine and jail terms in healthcare frau...

Ethicon Hemostatic Matrix Recall is Class 1

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FDA says an Ethicon recall of Surgiflo Hemostatic Matrix products due to a packing process issue is Class 1.

Lilly Plans Additional Alzheimers Drug Study

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Lilly says it will conduct an additional Phase 3 study of its investigational Alzheimers drug solanezumab before submitting a BLA ...