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Amicus receives U.S. approval for Fabry disease drug

U.S. health regulators approved Amicus Therapeutics’ Galafold as the first oral therapy to treat Fabry disease, a rare and sometimes fatal condition.

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FDA Shaves Four Months Off Amicus’ Fabry Drug Review Date

The FDA accepted Amicus Therapeutics’ NDA for migalastat to treat Fabry disease in patients with amenable mutations.

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Israel’s Protalix to Slash 20 Percent of Workforce

Share prices for Protalix Biotherapeutics were up more than 3 percent this morning after the company reported positive results from its Phase I/II open label extension trial of pegunigalsidase alfa, PRX-102, for the treatment of Fabry disease. Despite that positive news on its pipeline, Protalix is reportedly set to terminate 50 employees, which amounts to about 20 percent of its workforce.

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TherapeuticsMD Soars on Plans to Resubmit TX-004HR NDA Without New Pre-Approval Study

Shares of TherapeuticsMD Inc. shot up more than 51 percent in morning trading after the U.S. Food and Drug Administration reversed course on its rejection of that company’s vaginal pain medication.

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Amicus Ends Lead Rare Disease Drug Program

Amicus Therapeutics terminated a late-stage wound-treatment therapeutic after it failed to meet primary and secondary endpoints in a Phase III trial.

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Groundbreaking: Amicus Surges as FDA Changes Tune on Fabry Disease Drug

Amicus Therapeutics shares skyrocketed after the FDA reversed course on its Phase III treatment for Fabry disease. The change paves the way for Amicus to seek regulatory approval in 2017.

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Amicus Faces 3-Year Delay for Fabry Drug

Shares of Amicus Therapeutics plunged more than 22 percent after the company was forced to lay out plans for another clinical trial for its lead drug candidate migalastat.

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Protalix Sells Back ELELYSO Rights to Pfizer for $46 Million

Karmiel, Israel-based Protalix Biotherapeutics, Inc. (PLX) announced today that it was selling its share of a collaboration deal back to Pfizer Inc. (PFE)   Under the original deal, Pfizer took 60 percent and Protalix took 40 percent of revenues and expenses for the development and commercialization of ELELYSO, except in Israel and Brazil. Under the […]

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Amicus to delay filing for U.S. marketing rights for lead drug

* Amicus unlikely to file application this year * Had earlier expected to file application by Q4 * Drug aims to be first oral drug for Fabry disease * Company says European filing on track * Stock slumps as much as 59 pct (Adds details)   By Natalie Grover Oct 2 (Reuters) – Amicus Therapeutics […]

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