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Pfenex And Alvogen Suffer Teriparatide Setback

FDA Asks For More Data Before It Can Grant Equivalence

Executive Summary

Pfenex and partner Alvogen have suffered a setback on their PF708 teriparatide in the US, after the country’s Food and Drug Administration asked for more information to support a long-awaited designation of therapeutic equivalence to the Forteo brand.

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Pfenex And Alvogen Launch US Teriparatide

Pfenex marketing partner Alvogen has introduced the firm’s Bonsity version of teriparatide in the US. Representing the first Pfenex-developed product to hit the market, the launch comes as the companies are still awaiting a formal equivalence designation from the FDA.

Pfenex Gives Teriparatide Latest After Setback

Pfenex has provided an update on its bid to secure a therapeutic equivalence determination for its PF708 teriparatide product in the US, after itself and partner Alvogen were knocked back last month.

Pfenex Still Waiting For FDA Teriparatide Equivalence Designation

Hailing the past year as a "transformational period" in which "we moved towards being a business with an FDA-approved product nearing commercialization," Pfenex ended 2019 in profit and with cash in the bank, as it eyes the potential for a monopoly in the follow-on teriparatide market.

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