Category Archives: Bolus Insulin

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lilly to Acquire Sigilon Therapeutics; FDA Approves First Beta Cell Replacement Therapy for T1DM

Two cardiometabolic-related news items have been observed: Lilly announced it entered into an agreement to acquire Sigilon Therapeutics for ~$309.6M (view press release); and FDA approved Lantidra as the first beta cell replacement therapy for the treatment of T1DM in adults with severe hypoglycemia (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the future of T1DM cell therapies.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

NICE Requests Additional Tirzepatide T2DM Data; Insulet Initiates Omnipod 5 + Libre 2 Study; Esperion Files CLEAR Outcomes in EU; Nemaura Expands proBEAT Pilot; NeuroBo and Terns Announce Preclinical Obesity Data

A series of cardiometabolic news items have been observed from NICE, Insulet, Esperion, Nemaura, NeuroBo, and Terns. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

ADA 2023 Key Press Releases (June 24)

On the second day of ADA 2023, ten cardiometabolic-related news items were observed from Lilly, Zealand, BI, Novo Nordisk, Biomea Fusion, Sciwind Biosciences, Medtronic, Vertex, and Esperion. Below, FENIX provides context and analysis for the announcements.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

EMA Raises Thyroid Safety Concern Over GLP-1RAs; Madrigal Presents New MAESTRO-NASH Data; Expanded Libre 2 Coverage in France; Bayer Initiates Finerenone CKD + T1DM study; Bigfoot RWE Data Published; Mannkind Initiates INHALE-3 Switching Study

A series of cardiometabolic-related news items have been observed from EMA, Madrigal, Abbott, Bayer, Bigfoot, and Mannkind. Below, FENIX provides highlights and insights in the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

June CHMP Agenda; AstraZeneca Discontinues Oral GLP-1RA Development; Lilly Launches Insulin Affordability Awareness Campaign

Three cardiometabolic-related news have been observed: the CHMP agenda (view here) for this month’s meeting (June 19-22) has been released, including Jardiance’s EMPA-KIDNEY and Mounjaro obesity indication extensions; AstraZeneca announced it is discontinuing development of its oral, AZD0186 (view article); and Lilly announced a partnership with ADA and Adam Duvall to increase awareness of Lilly’s insulin affordability programs (view press release). Below, FENIX provides context and insight on the respective news items, including insight into how Novo’s OASIS 1 readout likely influenced AZ’s decision.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.