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Sanaria Malaria Vaccine Trial Reports Positive Results

[ Price : $8.95]

Rockville, MD-based Sanaria reports positive results from a trial of its malaria vaccine in an online issue of Science.

Marshall Edwards Initiates Phase 1 Trial with Anti-Tumor Drug

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Marshall Edwards initiates a Phase 1 clinical trial of its drug candidate ME-143 in patients with refractory solid tumors.

Generic Firms May Send Some Dear Doctor Letters: Judge

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A Nevada judge says a Supreme Court decision in a generic drug preemption case doesnt stop companies from sending Dear Doctor lett...

Ardea Bio Reaches Agreement on Phase 3 Gout Trial

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Ardea Biosciences completes formal end-of-Phase 2 meetings with FDA and reaches agreement on key aspects of a proposed Phase 2 tri...

Disagreements Continue on Separate Biosimilar User Fees

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The Generic Pharmaceutical Association disagrees with FDA, PhRMA, and BIO on the need for a separate biosimilars user fee program.

FDA Approves Jubilant's Generic Protonix

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FDA approves a Jubilant Life Sciences ANDA for a generic copy of Wyeths Protonix.

Agreement Reached on Generic Drug User Fee Goals

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Participants in negotiations for a generic drug user fee program reach agreement on program goals and funding.

Comments Sought on Petition Commissioner Regulations

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Federal Register Notice: FDA seeks comments on the reporting requirements in agency administrative procedures when a person aims t...

Panel Meeting Slated to Discuss Prostate Cancer Assay Postponed

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Federal Register Notice: FDA postpones a 10/14 meeting of the Immunology Devices Panel.

FDA Orders Class Warning for TNF-Alpha Blockers

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FDA orders a class boxed warning for all marketed tumor necrosis factor-alpha blockers to include information about a risk for inf...