Xeris Pharmaceuticals, Inc.
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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
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).
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.
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 Meanwhile, TETEC has withdrawn its EU marketing application for Artobend.
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