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Baxter, Halozyme amended HyQvia BLA in FDA hands

This article was originally published in Scrip

Executive Summary

Investors were generally pleased with the news Baxter International had completed its submission of an amended biologics license application (BLA) with hopes the FDA will reinitiate its review of HyQvia's (immune globulin infusion 10% (human)/recombinant human hyaluronidase) as a facilitated subcutaneous infusion to treat adults with primary immunodeficiency, a group of more than 175 disorders in which part of the body's immune system is missing or does not function properly.

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