FDA approves Glenmark’s first-in-human study for respiratory
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Glenmark Pharmaceuticals on Tuesday said the US health regulator has cleared its investigational new drug (IND) application to initiate a first-in-human study for a proposed biosimilar for use in treatment of respiratory or allergic disease. “The US Food and Drug Administration (USFDA) cleared the company’s investigational new drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar, which will assess its pharmacokinetics in comparison to XOLAIR in healthy adult volunteers between 18 and 65 years of age,” Glenmark said in a BSE filing.

“This marks the second IND activation in 2017 for our growing respiratory portfolio. GBR 310 has the potential to be among the first biosimilar candidates to be submitted for approval for a respiratory or allergic disease,” Glenmark Pharmaceuticals President and Chief Scientific Officer Kurt Stoeckli said.

Glenmark said GBR 310 is a recombinant DNA-derived humanised immunoglobulin G1 kappa monoclonal antibody....

http://indianexpress.com/article/lifestyle/health/fda-approves-glenmarks-first-in-human-study-for-respiratory-drug-4627353/
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