Biocon has reported that FDA issued a form 483 with six observations for its Malaysian facility. Recall, this facility is primarily responsible for the manufacturing of insulins including its biosimilar glargine. Biocon did not provide further details into the FDA observations.
In light of the recent journal publication of PRECISE II, the US pivotal IDE trial for Senseonics’s Eversense implantable CGM, FENIX has conducted a comparative analysis vs. Abbott Freestyle Libre and Dexcom G5 Mobile, with a particular focus on sensor accuracy across glucose ranges.
Insulet hosted its Q4 ’17 earnings call and provided commercial and R&D business updates. Below are highlights from the call.
Xeris Pharmaceuticals has announced the completion of two Ph3 clinical trials (adults and pediatrics) and one human factors study for its stable glucagon (no reconstitution required). According to the press release, the company anticipates to submit an NDA filing by the end of Q2 ’18.
It was reported on Twitter that at ATTD 2018, Dexcom displayed a slide (pictured below) showing a representation of a smart insulin pen. Additionally, Dexcom presented information on the “fully enhanced Dexcom G6 CGM system” including “Urgent Low Soon Alerts.”
Glooko announced FDA clearance of its Mobile Insulin Dosing System (MIDS). According to Glooko, the system analyzes FPG and recommends dose adjustments based on a pre-configured HCP plan or published clinical guidelines.
Abbott’s FreeStyle LibreLink is reportedly the first third-party iOS app to utilize Apple’s NFC technology (previously NFC use was limited to Apple Pay). The LibreLink app is believed to currently only be available in Europe, but it is assumed a US version is on the horizon.
AZ hosted their Q4 ’17 earnings call (press release) and briefly discussed their diabetes portfolio, with a particular focus on Farxiga and Bydureon.
Merck hosted their Q4 ’17 earnings call and briefly discussed Januvia and the newly-approved Stegaltro franchise.
Prime Therapeutics announced it has entered into a Jardiance outcomes-based contract (OBC) with BI as part of the Prime CareCentered Contracting program. According to the press release, Prime will measure outcomes by assessing the overall cost per patient on Jardiance vs “patients taking other diabetic medications.”