Tags : Xeris

Insights+: The US FDA New Drug Approvals in September and

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entities and 17 Biologics while breaking its last year’s record of approvals. However, there is a significant […]Read More

PharmaShots Weekly Snapshot (September 09 – 13, 2019)

1. Eisai And Biogen to Terminate Two P-III Clinical Studies of Elenbecestat (E2609) for Early Alzheimer’s Disease Published: Sept 13, 2019 | Tags: Eisai, Biogen, Terminate Two, P-III, Clinical Studies, Elenbecestat, E2609, Early Alzheimer’s Disease 2. GE Healthcare’s Critical Care Suite AI-Powered X-ray Device Receives FDA’s 510(k) Clearance to Identify Pneumothorax Published: Sept 12, 2019 | Tags: […]Read More

Xeris’ GVOKE (glucagon) Receives FDA’s Approval as The First Ready-To-Use

Shots:  The approval is based on three P-III studies (NCT02656069, NCT03091673, NCT03439072) assessing GVOKE vs conventional glucagon emergency kits in adults and children aged ≥2yrs. with T1D The studies demonstrated 100% treatment success in children & 99% in adults. Usability research assessing GVOKE PFS and GVOKE HypoPen resulted in ~100% success rate in administering a […]Read More