Category Archives: Glucose Monitoring

Biocorp and Novo Mallya Partnership; Nemaura Signs Contract for Non-invasive CGM EU Distribution; AHA Late-breaking Science Sessions Released; EASD 2021 Key Press Releases (Sept 27)

On the first day of EASD 2021, two key press releases were observed from Biocorp and Nemaura Medical. Additionally, AHA late-breaking science sessions have been released. Below FENIX provides insights and context from each respective announcement, including thoughts on how the Biocorp/Novo Nordisk partnership could signal Novo’s disposable connected pen solution is further behind than previously anticipated.

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New Non-invasive BGM; Amarin Updates Vascepa US Go-to-market Strategy; Welldoc Receives 510(k) Clearance for Bolus and Premixed Insulin Titration; CinFina Agreement with Janssen for QW Obesity Assets

A series of cardiometabolic-related news items have recently been observed: Know Labs announced the addition of KnowU, a portable Bio-RFID glucose monitoring device, to the company’s portfolio of non-invasive diagnostic technology; Amarin announced an update to its Vascepa go-to-market strategy, including US field force layoffs; Welldoc announced FDA 510(k) clearance for the BlueStar Insulin Adjustment Program for bolus and premixed insulin titration; and CinFina Pharma announced an agreement with Janssen Sciences Ireland Unlimited Company to acquire exclusive WW rights to four QW anorectic agents for the treatment fo obesity. Below, FENIX provides highlights and insights for the respective news items.

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Diamyd’s Ph3 T1DM Vaccine Placed on Partial Clinical Hold; Osama Hamdy Joins Nemaura Scientific Board; Medtronic Licenses Implantable Pump; Diabeloop joins the AACE Corporate Advisory Program and Appoints US Scientific Advisors

A series of cardiometabolic-related news items have been observed: Diamyd’s Ph3 has been placed on partial clinical hold (press release); Nemaura announced Osama Hamdy joined the company’s advisory board (press release); Medtronic licenses implantable insulin pump from the Alfred E. Mann Foundation (press release); Diabeloop joins the AACE Corporate Advisory Program and Appoints US Scientific Advisors (press release). Below, FENIX provides highlights and insights from the respective news items.

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Oral Sema Ph3 Obesity Program Initiated; GlucoModicum Appoints Former Dexcom Exec; Lilly Contributes to T1DM Camp Initiative

A series of cardiometabolic-related news items have recently been observed: a Novo Nordisk trial evaluating oral semaglutide in adults with obesity, called OASIS 1, has been observed on CT.gov; GlucoModicum announced the appointment of Peter Gerhardsson to Senior Advisor; and Lilly announced a commitment of nearly $1M donation over the next three years, in conjunction with the Helmsley Charitable Trust, to support a T1DM Camp Initiative. Below, FENIX provides highlights and insights for the respective news items.

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Gvoke Kit Receives FDA Approval; Medtronic Q2 ’21 Earnings Update

Two diabetes news items have been observed: Xeris announced FDA approved the sNDA for Gvoke Kit (1mg/0.2 mL single-dose vial syringe kit); and Medtronic hosted its CY Q2 ’21 (FY Q1 ’22) earnings call. Below, FENIX provides highlights and insights from the Medtronic call as well as thoughts on how Xeris’s decision to develop the Gvoke Kit was likely influenced by the channel mix.

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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.

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Xeris Expanded Payor Coverage; Movano Q2 ’21 Earnings Update

Xeris announced it has reached a milestone for Gvoke payor coverage and Movano hosted its Q2 ’21 earnings update. Of note, Gvoke Medicare access has reached 91% and commercial insurance access is at 88%. Below, FENIX provides highlights and insights for the respective news items.

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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.

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