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 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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