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Abbott Sues Impax to Block Generic Tricor

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Abbott Laboratories and Laboratoires Fournier SA sue Impax Labs over an ANDA for Tricor (fenofibrate) 48 mg and 145 mg tablets tha...

Salesman Says He Pushed Off-label Risperdal

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A Janssen salesman says he encouraged doctors to prescribe Risperdal for unapproved uses.

Geron and FDA Develop Plan to Lift Clinical Hold

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Geron Corp. says FDA has endorsed its plan to lift an agency-ordered clinical hold involving the companys human embryonic stem cel...

BIO Continues to Defend Lengthy Biosimilar Exclusivity

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BIO blasts GPhAs request to pull biosimilar legislation from healthcare reform unless it is significantly changed.

Stryker, Execs Indicted For Illegal Marketing

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A federal grand jury indicts Stryker Biotech and several of its executives on charges relating to alleged illegal marketing of its...

FDA Complete Response on Insomnia Drug

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FDA issues a complete response letter to Transcept Pharmaceuticals for Intermezzo (zolpidem tartrate) sublingual tablets.

FDA Amends Regs on IND Studies

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Federal Register Final rule: FDA amends its investigational new drug application regulations to direct applicants to submit INDs f...

AstraZeneca Settles Seroquel Marketing Allegations for $500 Million

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AstraZeneca says it has reached an agreement in principle with the U.S. Attorneys Office in Philadelphia to resolve investigations...

FDA Expands WebMD Consumer Info Partnership

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FDA says its partnership with WebMD is expanding to include more consumer health information.

FDAs Credibility Matters A Lot Sharfstein

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FDAs principal deputy commissioner Joshua Sharfstein tells the Alliance for a Stronger FDA that the agency is moving in the right ...