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KV Chairman is First Banned Exec

[ Price : $8.95]

The HHS inspector general says KV Pharmaceutical chairman Mark Hermelin is the first drug company executive to be banned from part...

FDA Continues View that Generic Drug Suits Not Preempted

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FDA tells an appeals court that a lower court ruling that failure-to-warn suits against manufacturers of generic Reglan are preemp...

FDA Grants ISTA 3-year Exclusivity for Bromday

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FDA grants ISTA Pharmaceuticals three years marketing exclusivity under the Hatch-Waxman Act for eye drug Bromday.

Promising Data on Merck Cholesterol Drug

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Phase 3 study data involving a Merck investigational drug show promising results for patients in managing their cholesterol levels...

Court Rules in Favor of Abilify Patent

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A New Jersey federal court rules that an Otsuka Pharmaceutical patent covering antipsychotic Abilify (aripiprazole) is valid and e...

Neuralstem Files IND to Treat Major Depression

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Neuralstem files an IND with FDA to begin two Phase 1 safety trials for NS1-189 for treating major depression.

Ascension Orthopedics Cited for Reporting, QS Violations

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FDAs Dallas District Office warns Ascension Orthopedics of reporting and Quality System violations at its manufacturing facility f...

CGMP Violations Found in 2 Nexgen Pharma Facilities

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FDAs Los Angeles District Office warns Nexgen Pharma of CGMP and other violations at two drug manufacturing facilities.

FDA Clears Canon Retinal Camera

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FDA clears a Canon USA. 510(k) for its Canon CR-2 Digital Non-Mydriatic Retinal Camera.

Anthera Pharma Lupus Trial on Hold

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Anthera Pharmaceuticals informs FDA about a voluntary hold on a Phase 2b study involving its investigational drug A-623 for treati...