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FDA Updates Off-Label Communications Guidance - Life Sciences, Biotechnology & Nanotechnology

On October 23, the U.S. Food and Drug Administration (FDA or Agency) released a much anticipated draft guidance entitled. ....

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Opening Moves in the ITC: Strategic Considerations for Pre-Institution Filings in Section 337 Investigations

The period following the filing of a section 337 complaint with the U.S. International Trade Commission (ITC) can be chaotic.. All section 337 litigants confront a series of strategic decisions that can send them on the path to success or failure in the investigation. ....

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Ensuring Innovation Act Changes Eligibility for New Chemical Exclusivity

Law aims to encourage competition in the pharmaceutical industry, making it easier for generics to enter market. ....

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Form DEF 14A AMARIN CORP PLC\UK

Form DEF 14A AMARIN CORP PLC\UK
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Hikma accuses Amarin of suppressing generic versions of heart pill

By Brendan Pierson (Reuters) - Generic drugmaker Hikma Pharmaceuticals USA Inc has sued Amarin Pharma Inc, accusing it of using illegal tactics to del. ....

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