Category Archives: Glucose Monitoring

InPen and Guardian 4 Sensor Receive CE Mark; Oramed Ph3 Oral Insulin Update; Adocia Files Patents for Obesity, NASH, and T2DM

Three cardiometabolic-related news items have recently been observed: Medtronic announced it received CE Mark for expanded functionality of its InPen smart insulin pen and its Guardian 4 CGM (aka Zeus); Oramed issued a letter to shareholders in which it highlighted its Ph3 oral insulin program (press release); and Adocia announced it has filed three patent families, which include obesity, NASH, and T2DM. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Roche Launches Smartphone-controlled Pump; Metronom Enters CGM JV in China; FDA Draft Guidance on T2DM Glycemic Control Devices; Dario Q1 ’21 Earnings Update; New Ascensia BGM Portal; Metacrine Ph2 NASH Trial

A series of cardiometabolic news items have been observed: Roche announced the launch of its mySugr Pump Control smartphone app; Dinova Medtech and Metronom Health have created a joint venture in China for CGM development and commercialization; FDA issued a draft guidance on medical devices intended to improve glycemic control in T2DM; Dario hosted its Q1 ’21 earnings call; Ascensia announced the launch of the new “GlucoContro.online” patient and provider portal for diabetes management and analytics; and Metacrine has enrolled the first 60 patients in its MET642 Ph2a NASH trial. Below, FENIX provides highlights and insights from the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Lilly Connected Pen Update; Novo Q1 ’21 Post-earnings Event; Provention Bio, BD, ICPT, and REGN Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly provided an update on its connected pen development, including the disclosure of the Tempo Smart Button (view press release); Novo Nordisk hosted its post-Q1 ’20 earnings event (see previous FENIX insight on Q1 ’21 Novo earnings from May 5); Provention Bio (press release), Becton Dickinson (press release), Intercept (press release; slides) and Regeneron (press release) hosted their respective CY Q1 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items, including thoughts on BD’s decision to spin off its diabetes business.

This content is for Read Less members only.
Already a member? Log in here

Tandem, Lannett, Esperion, and Ionis Q1 ’21 Earnings Updates; Nemaura Receives Order for its Non-invasive CGM

A series of cardiometabolic-related news items have recently been observed: Tandem, Lannett, Esperion, and Ionis hosted their respective Q1 ’21 earnings calls; and Nemaura Medical announced it received an order from its UK licensee, DB Ethitronix Ltd, of 5,000 sugarBEAT transmitters and 200,000 sugarBEAT sensors. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Welldoc Receives New Patent; Nemaura Shareholder Update; Sanofi and Teva Q1 ’21 Earnings Updates

Four cardiometabolic-related news items have been observed: Welldoc announced it recently received its 20th patent for “database management and graphical user interfaces for measurements collected by analyzing blood”; Nemaura Medical hosted a webcast and provided investors with brief updates to its business; and Sanofi and Teva hosted their respective Q1 ’21 earnings calls. Below, FENIX provides highlights and insights for the respective news items.

This content is for members only.
Already a member? Log in here

Novo to Initiate Oral Sema Ph3a Obesity Program; Integrity Applications Appoints David Klonoff to Scientific Advisory Board; Roche, Poxel, and Adocia Q1 ’21 Earnings Updates

A series of diabetes-related news items have recently been observed: Novo Nordisk announced its intention to enter Ph3a development of oral semaglutide in obesity; Integrity Applications announced the appointment of notable diabetes device KOL, David Klonoff, to its Scientific Advisory Board; Roche hosted its Q1 ’21 earnings call; Poxel issued its Q1 ’21 earnings and provided an update across its business including imeglimin for T2DM and PXL770/PXL065 for NASH; and Adocia announced its Q1 ’21 earnings update. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Novo QW Icodec Ph3 T1DM Trial Initiated; Dexcom G6 Approved for Upper Arm Wear in Canada; Dario Launches Virtual Health Initiative with MediOrbis; J&J and Abbott Q1 ’21 Earnings Updates

A series of diabetes-related news items have been observed: a CT.gov record for Novo’s Ph3 QW insulin icodec T1DM trial (ONWARDS 6) has been observed; Dexcom announced Health Canada has authorize G6 for upper arm wear; Dario announced a virtual care initiative with MediOrbis for telehealth and remote patient monitoring; Abbott hosted its Q1 ’21 earnings call; and J&J hosted its Q1 ’21 earnings call. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Insulet Omnipod 5 Tale-of-the-tape Analysis

In March 2021, Insulet presented Omnipod 5 pivotal data at the ENDO conference in which Omnipod 5 was shown to reach 68-74% TIR with low rates of hypoglycemia (time spent 54 mg/dL of 0.17% in adults and 0.23% in pediatrics). Below, FENIX provides a tale-of-the-tape comparative analysis between Omnipod 5, Tandem’s Control IQ, and Medtronic’s 780G AHCL, as well as additional thoughts on how Omnipod 5 may effect new entrants to the market.

This content is for members only.
Already a member? Log in here