Category Archives: Bolus Insulin

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.

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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.

Biocon Completes Viatris Biosimilars Business Acquisition; Nemaura Launches Miboko Pilot Program in UK; BMS Terminates CV Partnership with uniQure

Three cardiometabolic-related news items have been observed: Biocon announced (view press release) the completed acquisition of Viatris’s biosimilar business (view press release); Nemaura announced the launch of its Miboko pilot program in the UK (view press release); and BMS reportedly terminated its research collaboration with uniQure (view article). Below, FENIX provides context and insight on the respective news items, including Nemaura’s challenged balance sheet.

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 and Novo Leave Twitter Advertising; Insulet Issues O5 Medical Device Correction; Biocon, Movano, and Nemaura Q3 ’22 Earnings Updates

A series of cardiometabolic-related updates have been observed: Lilly (view article) and Novo (view article) have reportedly halted Twitter advertising; Insulet announced an Omnipod 5 voluntary medical device correction in the US; Biocon (press release), Movano (press release), and Nemaura (press release) hosted their respective Q3 ’22 earnings calls. Below, FENIX provides context and insight on 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 and Lannett Q3 ’22 Earnings Updates; Indigo Expands into US; OrsoBio Acquires T2DM and NASH Assets

A series of cardiometabolic-related news items have been observed: Tandem (press release) and Lannett (press release) hosted their CY Q3 ’22 earnings calls; Indigo Diabetes announced the creation of a US entity and appointment of Peter Devlin as President to support the development and commercialization of its continuous multi-metabolite (CMM) device; and Orso Bio acquired a T2DM asset from Shionogi (press release) and exclusive global rights for intellectual property from Yale University to develop mitochondrial protonophores (press release). Below, FENIX provides highlights and insights for the respective new 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.

Novartis and Adocia Q3 ’22 Earnings Updates

Two cardiometabolic-related news items have been observed; Novartis (press release; slides) hosted its Q3 ’22 earnings call; and Adocia issued a press release for its Q3 ’22 earnings, though it did not host an associated webcast. Below, FENIX provides highlights and insights from the respective new 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.