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Xeris Pharmaceuticals, Inc.

http://www.xerispharma.com

Latest From Xeris Pharmaceuticals, Inc.

Keeping Track: Zegalogue Joins Hypoglycemia Space; Keytruda Earns First-Line Esophageal Cancer Claim

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Drug Review

Zealand Set To Take On Lilly After Zegalogue US Approval

Despite being third to market behind Lilly’s Baqsimi and Xeris’s Gvoke to treat emergency episodes of hypoglycemia, Zealand is confident of a successful US launch for Zegalogue (dasiglucagon).

Metabolic Disorders Approvals

Dsuvia Gets Warning Letter As US FDA’s Opioid Decisions Complicate Commissioner Race

AcelRx oversimplified Dsuvia’s ease of use, Office of Prescription Drug Promotion says. Focus on opioid safety comes as critics of Janet Woodcock have pointed to FDA’s decisions in the space as disqualifying her for FDA commissioner. Letter appears to reflect long-standing FDA concerns: Dsuvia was approved with a REMS related to administration issues, and Xeris received a similar warning letter last year for exaggerating the ease of use of its glucagon pre-filled syringe Gvoke PFS.

FDA Advertising, Marketing & Sales

EU Approvals Beckon For Inrebic & Novel Adalimumab Biosimilar

Inrebic, Celgene’s myelofibrosis treatment, and Yuflyma, Celltrion’s high-concentration adalimumab biosimilar, are among the latest new drugs that have been recommended for approval for use across the EU. Meanwhile, TETEC has withdrawn its EU marketing application for Artobend.

Europe Approvals
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Company Information

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  • Pharmaceuticals
    • Specialty Pharmaceuticals
    • Drug Delivery
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  • Biotechnology
    • Large Molecule
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