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Teva Catches A Break On Copaxone 40mg, But For How Long?

Executive Summary

An FDA warning letter cites deficiencies at the Pfizer-owned manufacturing facility poised to produce a Momenta/Sandoz generic competitor. It’s unclear how long Pfizer might take to resolve the violations, which include particulates in finished products.

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Teva Undertaking Strategic Review As It Searches For New CEO

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Teva CEO Steps Down While An Integration Hangs In The Balance

After a damaging court ruling on Copaxone 40 mg and some management missteps, CEO Erez Vigodman will step down as CEO of the Israeli generic drug leader. Chairman Yitzhak Peterburg will fill in on an interim basis.

Copaxone 40mg Generic At-Risk Launch Anticipated As Soon As February

Teva is seeking injunction to block generic entry after court rules four patents on the three-times-a-week dosage are invalid; analysts expect launch soon after FDA approves an ANDA, with Sandoz/Momenta generic the likely leader.

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