Category Archives: Bolus Insulin

Wegovy Advertising Paused Due to High Demand; Inventiva Ph2 Lanifibranor T2DM and NAFLD Results; FDA Accepts Gan & Lee’s Bs-Aspart BLA

Three cardiometabolic-related news items have been observed: Ro has reportedly paused its Wegovy advertising due to the ongoing supply shortage (view article); Inventiva announced positive topline results from its Ph2 trial evaluating lanifibranor in patients with T2DM and NAFLD (view press release); and Gan & Lee announced FDA accepted the BLA for its biosimilar insulin aspart (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the ongoing Wegovy supply issues.

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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Senate Targets PBMs and Insulin Manufacturers; Zealand and Dario Q1 ’23 Earnings; Cytokinetics Initiates Ph1 Trial for Potential HFpEF Therapy

Four cardiometabolic-related news items have been observed: On May 10, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a widely covered hearing with Sanofi, Lilly, and Novo Nordisk’s CEOs as well as executives from top PBMs (view broadcast here); Zealand Pharma (view press release; slides) and Dario (press release) hosted their respective Q1 ‘23 earnings calls; and Cytokinetics announced the initiation of a Ph1 trial evaluating CK-4021586 (CK-586) as a potential treatment for HFpEF (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.

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Purchase Blast$599.00

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

Sanofi Follows Lilly and Novo’s Insulin Price Cuts

Sanofi announced it will cut the Lantus WAC price by 78% and cap the monthly out-of-pocket cost at $35 for commercially insured patients. Additionally, Sanofi will cut the WAC price of Apidra by 70%. The move follows similar insulin price cuts by Lilly (previous FENIX insight) and Novo Nordisk (previous FENIX insight). According to the press release, the price decreases will take effect on January 1, 2024. Below, FENIX provides an updated insulin pricing analysis.

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.

Novo Nordisk to Lower US Insulin Prices

Novo Nordisk announced plans to lower prices for its pre-filled insulin pens and vials by 65-75% starting January 1, 2024. The news follows a similar move recently made by Lilly to cap most of its US insulin costs at $35/month (previous FENIX insight). Below, FENIX provides highlights and insights into Novo’s insulin price cuts, including an updated RAI and basal insulin pricing analysis.

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.

CMS Expands CGM Coverage; New Novo R&D Presence in Boston; Bigfoot Unity Android App Approval; Cytokinetic Receives Omecamtiv CRL; Galectin Finalizes Ph2b/3 NAVIGATE Randomization; Imcyse Completes Trial Enrollment; and Zealand, Intercept, and Amarin Q4 ’22 Earnings

A series of cardiometabolic-related news items has been observed from CMS, Novo Nordisk, Bigfoot, Zealand, Intercept, Cytokinetics, Amarin, Galectin, and Imcyse. 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.

US Insulin Pricing Analysis: Lilly cuts insulin prices by 70% and caps out-of-pocket costs at $35 per month

Lilly announced price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program which caps patients’ out-of-pocket costs at $35 per month or less. Of note, President Joe Biden has already issued a statement stating Lilly’s move is “a big deal, and it’s time for other manufacturers to follow” (view article). Below, FENIX provides highlights and insights into Lilly’s rationale for the price reductions as well as an RAI and basal insulin pricing analysis.

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.

Sanofi and Regeneron Q4 ’22 Earnings Updates

Two cardiometabolic-related news items have been observed: Sanofi (press release; slides) and Regeneron (press release; slides) hosted their respective Q4 ’22 earnings calls. Below, FENIX provides highlights and insights from the earnings calls.

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.

Rybelsus Approved as First-Line Therapy for T2DM; Biocon Receives Another CRL; Tandem Initiates Control-IQ 2.0 Feasibility Study in T1DM

Three cardiometabolic-related news items have been observed: Novo Nordisk announced FDA approved an updated label for Rybelsus, allowing for first-line use (view press release); Biocon received a CRL from FDA for its biosimilar Insulin-R (view announcement); and Tandem initiated a T1DM feasibility study using an updated Control-IQ 2.0 algorithm (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including thoughts on the impact of the updated Rybelsus label.

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.

JPM 2023 Day 4: TNDM, ICPT, LXRX, MNKD, and XERS; Oramed Discontinues Ph3 Development ORMD-0801 in T2DM; Versanis Initiates Ph2b Obesity Trial Enrollment

On the fourth and final day of JPM 2023, FENIX has provided coverage of presentations by other CVRM companies including Tandem, Intercept, Lexicon, MannKind, and Xeris. Separately, two CVRM-related news items have been observed: Oramed announced its oral insulin (ORMD-0801) failed to meet primary and secondary endpoints in the first Ph3 T2DM study, and the company is discontinuing development in T2DM (view press release); and Versanis Bio announced that the BELIEVE Ph2b study evaluating bimagrumab alone and in combination with semaglutide for the treatment of obesity has begun enrolling patients (view press release).

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.

Holiday Hangover: Novo’s Wegovy/Ozempic Featured on 60 Minutes; Intercept OCA NASH NDA Refiled; Amgen Initiates Ph2 AMG 133 Obesity Trial; Steven Russell Joins Beta Bionics; Novo’s Third Cagrisema Ph3 Trial Initiated; Wegovy Pediatric Indication; Lannett Bs-Insulin Updates; Equillium and Metacrine Terminate Merger; and More

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Intercept, Amgen, Beta Bionics, Lannett, Equillium and Metacrine, MindRank, EOFlow, Medtronic, Adocia, and PeptiDream. 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.