Category Archives: Basal Insulin

EASD 2023 Key Press Releases (Oct 02)

On the first day of EASD 2023, two key news items were observed from Novo Nordisk and Dexcom. The following topics are covered below (hyperlinks below are to external 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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Lilly Initiates New Ph2 Study Investigating High Doses of Tirzepatide in Patients with T2DM and Obesity; Gan & Lee Doses First Patient in Ph2 QW Insulin Study; BMS discontinues NASH asset

Three cardiometabolic-related news items have been observed: Lilly initiated a Ph2 study to investigate high doses of tirzepatide in patients with T2DM and obesity that are on metformin (view CT.gov record); Gan & Lee announced the first subject has been dosed in its Ph2 study evaluating QW insulin, GZR4, in 130 Chinese adult subjects with T2DM (view press release); and BMS disclosed it is terminating its program evaluating HSP47 in NASH during its R&D day (view article). 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.

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.

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.

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.

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.

Gan & Lee Submits Bs-glargine MAA

Gan & Lee Pharmaceuticals announced the MAA for its biosimilar insulin glargine U100 (Basalin) has been accepted for review by EMA. According to the press release, the MAA filing is supported by two randomized, multicenter Ph3 studies in the US and EU comparing its bs-glargine injection to Lantus in which bs-glargine demonstrated comparable immunogenicity, efficacy, and safety to Lantus in T1DM (n=576) and T2DM (n=567) patients (previous FENIX insight). G&L said it will continue to collaborate with Sandoz to commercialize its bs-glargine in the EU. Recall, in February 2023, G&L announced FDA accepted the BLA for its bs-glargine (previous FENIX insight). Below, FENIX provides brief thoughts on the G&L bs-glargine MAA in the context of the evolving basal insulin market.

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.

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.

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, 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.

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.

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.

Abbott Q2 ’23 Earnings; Merck Initiates Ph3 Oral PCSK9i Program; Pfizer Partners with Riparian for CV Development; Amarin Corporate Updates; J&J Q2 ’23 Earnings

Five cardiometabolic-related news items have been observed from Abbott, Merck, Pfizer, Amarin, and Johnson & Johnson. Importantly, Abbott disclosed it is converting Libre 2 intermittent scanning CGMs into real-time CGMs through an app update, starting with the UK. Below, FENIX provides highlights and insights from the respective news items, including potential insight into Abbott’s rationale for the Libre 2 LCM initiative.

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.