Category Archives: Bolus Insulin

Medtronic Expands 630G/670G Pump Recall; Xeris Completes Acquisition of Strongbridge; DreaMed FDA Clearance for AI-based Clinical Decision Support System for T2DM; Know Labs Bio-RFID Readings Comparable to FDA-Cleared Devices

A series of cardiometabolic-related news items have been observed: Medtronic recalled 600 series insulin pumps (view FDA website); Xeris announced the closing of its acquisition of Strongbridge BioPharma; DreaMed announced FDA clearance of its AI-based clinical decision support system, called Advisor Pro, for patients with T2DM; Know Labs published a report that shows the accuracy of its non-invasive Bio-RFID technology blood glucose sensor is comparable to FDA-cleared devices (press release; view report). Below, FENIX provides further highlights and insights for the respective news items.  Medtronic expands 630G/670G pump recall Medtronic recently recalled an expanded set of its 600 series insulin pumps (630G and 670G)……

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

BI/Lilly Launch Educational CVRM Game for HCPs; MannKind INHALE-1 Pediatric Study Enrolls First Patient; Dietitian-based Resource with PWD Launched

Three cardiometabolic-related news items have been observed: BI/Lilly announced the launch of an educational initiative for HCPs, called CRMSynced, which uses gamification to encourage HCPs to prioritize a holistic approach to disease management; MannKind announced the first patient has been enrolled in the Afrezza Ph3 pediatric study; Teatis announced the launch of Teatis RD on Demand, a resource designed to connect people with diabetes to dietitians who can assist in managing their disease through personalized meal plans. Below, FENIX provides highlights and insights for the respective new items.

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

September 13-16 CHMP Agenda; Dexcom Exec Joins iRhythm as CEO; Provention Teplizumab Update

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month (September 13-16) has been released; iRhythm announced Quentin Blackford, outgoing Dexcom COO, will join the company as President and CEO, effective October 4, 2021; and Provention Bio issued an update on the BLA resubmission of teplizumab to delay the onset of T1DM in at-risk individuals (press release). Below, FENIX provides highlights and insights from the respective news items.

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

Lannett CY Q2 ‘21 (FY Q4 ’21) Earnings Update

Lannett hosted its CY Q2 ’21 (FY Q4 ’21) earnings call in which it provided brief updates to its biosimilar glargine U100 and biosimilar aspart development programs. Of note, Lannett now anticipates filing the bs-glargine BLA in H1 ’23 (previously “later in 2022”) with a US launch planned for H1 ’24 (previously 2023). Below, FENIX provides highlights and insights from the call.

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

Lyumjev Approved for Insulin Pump Use; Dario and Nemaura Q2 ’21 Earnings Updates; CHMP Agenda August 16-19

A series of cardiometabolic-related news items have been observed: Lilly announced FDA approved Lyumjev for pump compatibility; Dario hosted its Q2 ’21 earnings call (press release); Nemaura Medical published its CY Q2 ’21 (FY Q1 ’22) business update (press release); and the CHMP agenda for this month’s meeting (August 16-19) has been released. Below, FENIX highlights and insights for the respective new items.

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

New Non-invasive CGM Startup Raises $11.7M in Series B; Zealand, Mannkind, and Metacrine Q2 ’21 Earnings Updates; Integrity Applications Reverse Stock Split

A series of cardiometabolic-related news items have been observed: Hagar announced it has raised $11.7M in Series B financing for the clinical development of a non-invasive CGM; Zealand, Mannkind, and Metacrine hosted their Q2 ’21 earnings calls; and Integrity Applications announced it has implemented a 1-for-13 reverse stock split. Below, FENIX provides highlights and insights for the respective news items.

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

Viatris and Senseonics Q2 ’21 Earnings Updates; Forxiga CKD EU Approval; GoodRx and BI Patient Access Initiative; Diamyd EU Patent Granted; New Glooko CTO

A series of cardiometabolic-related news items have been observed: Viatris and Senseonics hosted their respective Q2 ’21 earnings calls; AstraZeneca announced EU approval of Forxiga for the treatment of CKD in adults with and without T2DM; GoodRx and BI announced an initiative to increase access to cost-savings programs for patients with T2DM and COPD; Diamyd announced the European Patent Office has granted the Diamyd’s recent patent application for treatment using GAD; and Glooko announced Prakash Menon has been appointed as the company’s Chief Technology Officer. Below, FENIX provides highlights and insights for the respective news items.

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

Wegovy Launch Impresses; Guidance Raised; Novo Q2 ’21 Earnings Update

Novo Nordisk hosted its Q2 ’21 earnings call and provided updates across its commercial and pipeline activities, including the ongoing Wegovy and Rybelsus launches and Novo’s intentions to develop and launch an ASCVD or HF product between 2024 and 2028. Of note, the earnings call was previously scheduled for tomorrow (August 5, 2021), but the company curiously moved it up by a day. Below, FENIX provides highlights and insights from the call.

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