Glooko announced it has appointed Mark Clements as the company’s new CMO. Recall, Clements is a pediatric endocrinologist from Kansas City, MO who has sat on the Glooko board since 2015. He also served as the Pediatric Chair of T1D Exchange. Below, FENIX provides insight into how Clements fits into Glooko’s business needs.
Lifescan announced it has entered into an exclusive partnership with Sanvita Medical for the distribution of Sanvita’s CGM. According to the press release, the companies are planning to launch the CGM in North America and select EU countries starting as early as mid-2020. Additionally, Lifescan recently appointed former J&J VP, Ty Lee, as the new Head of Marketing. Below, FENIX provides insight on Lifescan being the last of the Big 4 BGM manufacturers to move into the CGM market and thoughts on Ty Lee re-joining the Lifescan organization.
FDA issued a safety communication regarding the use of unauthorized devices as part of closed-loop systems. Additionally, FDA said it has identified companies who are “illegally marketing components, such as unauthorized continuous glucose monitors that some patients may integrate into unauthorized automated insulin dosing systems.” According to the FDA communication, the warning is based on a report that a patient received too much insulin resulting in the need for medical intervention. Below, FENIX provides insight on the FDA communication including the potential impact on current closed-loop systems in development as well as thoughts on potential systems that are being marketed illegally.
ADA 2019 abstract and session titles are available through the ADA desktop app. According to the ADA website, full abstract text will be available Tuesday, June 4 at 5:00 pm ET.
Senseonics and Beckton Dickinson hosted their respective CY Q1 ’19 earnings calls and provided updates to their diabetes businesses. Additionally, Xeris Pharmaceuticals released its Q1 ’19 earnings but did not have an associated call. Of note, BD disclosed that the launch of its T2DM patch pump (called “Swatch”) will be delayed after it received feedback from FDA. Below, FENIX provides highlights and insights from the calls.
Dexcom hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, this is believed to be the first time that Dexcom distributed slides as part of an earnings release. Below, FENIX provides highlights and insights from the earnings call.
Lilly hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for “technical reasons,” and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 ’19 regulatory events in diabetes.
Abbott and Roche hosted their respective Q1 ’19 earnings calls and provided brief updates to their diabetes businesses. Of note, Abbott disclosed its Libre 2 US filing includes a request for iCGM designation. Below, FENIX provides highlights and insights from the calls.
Medtronic announced it has signed an outcomes-based contract (OBC) with BCBS of Minnesota for the standalone Guardian Connect CGM. According to the press release, the OBC is based on time-in-range metrics. In return, Guardian Connect will be distributed through the BCBS Minnesota pharmacy benefit. While the press release does not specify, it is believed that both insulin-dependent T1DM and T2DM patients are eligible. Below, FENIX provides thoughts on the Medtronic CGM OBC and how it could impact other CGM manufacturers, notably Dexcom and Abbott.
WaveForm Technologies (subsidiary of AgaMatrix) announced it has formed a partnership with A. Menarini to commercialize WaveForm’s CGM in EMEA and Latin America. The WaveForm CGM is not yet available; however, the company anticipates receiving CE Mark in 2019. Below, FENIX provides thoughts on the partnership.