Category Archives: Bolus Insulin

Novo’s FLOW Stops Early; Akero Misses in Ph2b NASH Study; Insulet Wins Preliminary Injunction Against EOFlow; Biocon Recieves Another CRL; Inpefa Receives Preferred Formulary Status with ESI; Carmot Oral GLP-1RA Ph1 Data

A series of cardiometabolic-related news items have been observed from Novo, Akero, Insulet, Biocon, Lexicon, and Carmot Therapeutics. Below, FENIX provides highlights and insights into the respective news items, including thoughts on the potential impact of Akero’s study results.

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Best Buy to Sell Dexcom G7; Gan & Lee Submits Bs-aspart and Bs-lispro MAAs; October CHMP Agenda; Tom Garner Joins Lexicon as SVP and CCO; Dario Partners with a Top Five Employee Benefits Consulting Firm; Senseonics and Ascensia Launch Eversense E3 Advertising Campaign

A series of cardiometabolic-related news items have been observed from BestBuy/Dexcom, Gan & Lee, EMA, Lexicon, Dario, and Senseonics/Ascensia. Below, FENIX provides highlights and insights into the respective news items.

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September CHMP Agenda; Nemaura Announces Interim 24-Hour Wear sugarBEAT Results; Madrigal Appoints Bill Sibold as CEO

Three cardiometabolic-related news items have been observed: The CHMP agenda (view here) for this month’s meeting (September 11-14) has been released; Nemaura Medical announced interim results from a 100-patient study across 4 cohorts of 25 (view press release); and Madrigal Pharmaceuticals announced Bill Sibold as the successor to Paul Friedman as CEO (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Beta Bionics Secures $100M in Series D Funding; Senators Ask for Clarity on Lilly, Novo, and Sanofi’s Low-cost Insulin Products

Two cardiometabolic-related news items have been observed: Beta Bionics announced its Series D funding round has been closed at $100M (view press release); and senators have sent a letter to the CEOs of Lilly, Novo Nordisk, and Sanofi asking for greater clarification on how patients may participate in each company’s Patient Assistance Programs to obtain insulin at an affordable price (view letter; view article). Below, FENIX provides highlights and insights for the respective news items.

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Novo Partners with Thermo Fisher as Second Wegovy Manufacturer; Bayer Initiates New Finerenone HF Study; Welldoc’s BlueStar Receives 510(k) Clearance for CGM-mediated Dose Recommendations

Three cardiometabolic-related news items have been observed: Novo Nordisk has hired Thermo Fisher as its second contract manufacturer for Wegovy (view article); Bayer initiated a Ph3 study evaluating the safety and efficacy of finerenone in patients hospitalized with acute decompensated HF and mildly reduced or preserved LVEF (REDEFINE-HF; view CT.gov record); and Welldoc announced it received its eleventh 510(k) clearance for BlueStar to provide bolus insulin dose recommendations based on CGM data (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Insulet Files Lawsuit Against EOFlow; Amazon Pharmacy Launches $35 Insulin Coupon; Welldoc Receives 510(k) Clearance for Connected Insulin Dosing Data; Dario Partners with PlanSource

Four cardiometabolic-related news items have been observed: Insulet filed a lawsuit against EOFlow, claiming the company copied patented components of its Omnipod devices (view article); Amazon Pharmacy announced it is rolling out “automatic coupons” to reduce customer costs for insulin to as low as $35/month (view article); Welldoc announced it received its tenth 510(k) clearance for BlueStar to use insulin dosing data from connected devices for its personalized bolus dosing recommendations (view press release); and DarioHealth announced a new agreement with PlanSource to offer digital health solutions to >5M consumers (view press release). Below FENIX provides highlights and insights for the respective news items.

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Tandem, Lexicon, and Amgen Q2 ‘23 Earnings

Three cardiometabolic-related news items have been observed: Tandem Diabetes Care (view press release), Lexicon (view press release), and Amgen (press release; slides) hosted their respective Q2 ‘23 earnings calls. Below, FENIX provides highlights and insights into the respective news items.

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Afon to Launch Non-Invasive Blood Glucose Sensor in 2024; DEKA ACE Pump Receives 510(k) Clearance; Novo Nordisk Launches Wegovy in Germany; Ionis Completes CARDIO-TTRansform Enrollment

Four cardiometabolic-related news have been observed: Afon Technology is planning to launch a noninvasive blood glucose sensor, called Glucowear, in 2024 (view article); DEKA Research and Development received 510(k) clearance for its DEKA ACE Pump System (view 510(k) decision letter); Novo Nordisk launched Wegovy in Germany without coverage from public health insurance (view article); and Ionis announced the completion of enrollment for its Ph3 CARDIO-TTRansform CVOT of eplontersen in patients with ATTR-CM (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items, including thoughts on who may be interested in commercializing the DEKA pump.

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Biocon Receives Even More Form 483 Observations; Roche and Alnylam Partner for Hypertension RNAi; Dario Issues Preliminary Q2 ’23 Results and Business Update

Three cardiometabolic-related news items have been observed: Biocon announced FDA conducted two cGMP inspections at Biocon’s insulin manufacturing facility in Malaysia and issued eight Form 483 observations (view press release); Roche and Alnylam announced a strategic agreement to co-develop and co-commercialize zilebesiran for the treatment of hypertension; and Dario announced a new agreement with an undisclosed large regional health plan as well as preliminary Q2 ’23 results (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Tandem Mobi Receives FDA Clearance; Better Therapeutics’s AspyreRx Receives FDA Authorization for T2DM

Two cardiometabolic-related news items have been observed: Tandem announced FDA clearance of the Tandem Mobi insulin pump for PWD ≥6 years of age (view press release); and Better Therapeutics announced FDA authorized AspyreRx to provide cognitive behavioral therapy for adults with T2DM and held an associated investor call (view press release; webcast). Below, FENIX provides highlights and insights into the respective news items.

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