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Payer Issues Seen as the Biggest Barrier to New Orphan Drugs

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Payer and reimbursement issuesnot sciencepose the greatest potential impediment to providing new therapies for patients with rare ...

Circulatory System Devices Panel to Discuss 2 PMAs

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 12/7-8 to discuss a Medtronic PMA supplement and a Cardio...

FDA Approves 'Iron Overload' Drug

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FDA approves an ApoPharma NDA Ferriprox (deferiprone) to treat thalassemia patients who've had a blood transfusion that caused iro...

Experts Tell How to Fund Rare Disease Drug R & D

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Panelists at the U.S. Conference on Rare Diseases and Orphan Products explore the role and evolution of private research foundatio...

NEJM Examines 'Pay-for-delay' Generic Settlements

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This week's New England Journal of Medicine includes an article by Harvard professors that examines the history of, and potential ...

WHO Calls for a Switch Away from Dental Amalgam

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In a new 61-page report, the World Health Organization calls for a switch away from use of dental amalgam because it is a signific...

Asthma Drug Spending 4 Times Higher in 10 Years

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The Agency on Healthcare Research and Quality says that spending on Rx asthma drugs has quadrupled in 10 years.

Noven Sues Watson for Daytrana Patent Infringement

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Noven Pharmaceutical files a lawsuit against Watson Pharmaceuticals for infringement of a patent for ADHD patch Daytrana.

FDA Clears Candelis Software Suite

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FDA clears a Candelis 510(k) for its ASTRA cloud-hosted software suite for medical image transmission.

Reviewers Question Azilect Efficacy for New Indication

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FDA medical reviewers tell the Peripheral and Central Nervous System Drugs Advisory Committee they have questions about Azilects e...