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Xeris Pharmaceuticals, Inc.

http://www.xerispharma.com

Latest From Xeris Pharmaceuticals, Inc.

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 Meanwhile, TETEC has withdrawn its EU marketing application for Artobend.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

Addyi Radio Ad’s Lack Of Alcohol Risk Information Elicits New Clash With US FDA

Agency directs Sprout to disseminate corrective messages about the risks associated with the female sexual dysfunction pill. Sprout previously challenged FDA’s alcohol labeling requirements.

Ad Complaints Advertising, Marketing & Sales

FDA Objects To ‘Pretty Easy, Huh?’ TV Ad For Gvoke Injection Diabetes Drug

In its second letter of the year, US Office of Prescription Drug Promotion says Xeris Pharmaceuticals’ television ad fails to include important risk information and misleadingly suggests Gvoke pre-filled syringe can be easily used.

Advertising, Marketing & Sales Enforcement
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