Keyword: drug approval

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Drug Industry Treading Water on R&D Productivity

04.12.2012 - Drug companies are becoming more efficient in hunting for new treatments, though this has yet to be reflected in improved investment returns, according to a report on Tuesday. Low...

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U.S. Supreme Court to Review Lawsuits over Flaws in Generic Drugs

02.12.2012 - The U.S. Supreme Court on Friday agreed to consider whether generic drug manufacturers can be subjected to personal injury lawsuits that allege flaws in the design of drugs, even...

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Europe Approves High-Price Gene Therapy

02.11.2012 - European officials have approved the Western world's first gene therapy drug from a small Dutch biotech company, in a milestone for the novel medical technology that fixes faulty...

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FDA Reviewers Spot Safety Concerns With Sanofi, Isis Lipid Drug

17.10.2012 - U.S. drug reviewers flagged several safety concerns, including possible cancer risks, related to Sanofi and Isis Pharmaceuticals's lipid disorder drug Kynamro, sending Isis's...

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Novartis Drug Afinitor Gets EU Nod for Breast Cancer

30.07.2012 - Novartis drug Afinitor, expected to become a major seller for the Swiss drugmaker, was approved by European regulators to treat women with a certain type of breast cancer, the...

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U.S. Health Advisers Back Two New Eye Treatments

27.07.2012 - A U.S. Food and Drug Administration panel on Thursday recommended two drugs for combating different forms of vision loss that can lead to blindness among a range of adults...

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EU Set to Simplify Clinical Trial Rules

11.07.2012 - The European Union's executive is due to propose new rules next week to make it easier for drug companies and researchers to carry out cross-border clinical trials, in a bid to cut...

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K-V Sues FDA over Makena in Fight for Survival

06.07.2012 - K-V Pharmaceutical is suing the U.S. Food and Drug Administration for not cracking down on compounded versions of its premature birth drug Makena, in a last-ditch fight for the...