Tag Archives: Lilly

Provention Bio Refiles Teplizumab BLA; Medtronic and Tandem Q4 ’21 and FY ’21 Earnings Updates; Lilly Invests $700M in New Lilly Institute for Genetic Medicine; RosVivo Therapeutics and Lilly Sign MTA for RSVI-301; February 21-24 CHMP Agenda

A series of cardiometabolic-related news items have recently been observed from Provention Bio, Medtronic, Tandem, Lilly, RosVivo Therapeutics, and the CHMP. 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.

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ICER Report Questions Tirzepatide’s Effectiveness Compared to Ozempic and Jardiance; Signos and Dexcom to Launch CGM+AI-Enhanced App Trial; Teladoc Launches Chronic Care Complete Program; Movano Completes Second Glucose Pilot Study; Better Therapeutic Enrolls First Patient in BT-001 RWE Study

A series of cardiometabolic-related news items have been observed: The Institute for Clinical and Economic Review (ICER) released its report on Lilly’s tirzepatide (view article); Signos announced intentions to conduct a health outcomes study (in partnership with Dexcom) investigating CGM+AI-enhanced app use in people without diabetes; Teladoc announced it has launched its Chronic Care Complete program; Movano announced the completion of its second IRB-approved glucose pilot study evaluating its wrist-worn wearable biosensor prototype; and Better Therapeutics announced the first patient has been enrolled in an RWE study evaluating BT-001 for the treatment of T2DM. 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.

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Purchase Blast$599.00

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

Did Lilly Purchase BioMarin’s PRV?; Rivus Announces Positive Ph2a HU6 Trial Results; Second Sight to Merge with Nano Precision for GLP-1RA Implantable

Three cardiometabolic-related news items have been observed: BioMarin announced it sold a PRV for $110M but did not disclose the buyer; Rivus Pharmaceuticals announced positive results from its Ph2a HU6 trial; and Second Sight Medical Products and Nano Precision Medical (NPM) announced that they have entered into a definitive merger agreement. Below, FENIX provides highlights and insights for the respective new items, including thoughts on why Lilly may have been the company to purchase BioMarin’s PRV.

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 Q4 ‘21 and FY ‘21 Earnings Update

Lilly hosted its Q4 ’21 earnings call (press release; slides) and provided updates across its CVRM portfolio with a particular focus on tirzepatide. Of note, Lilly did not discuss its CVRM pipeline assets including its QW insulin (basal insulin Fc) which is scheduled to enter Ph3 this year. Below are highlights and insights from the call.

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

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Insulet Omnipod 5 Receives FDA Clearance; BI/Lilly’s Jardiance HFpEF Indication Receives Positive CHMP Opinion; Provention Hosts Teplizumab BLA Resubmission Call with Investors; Lilly to Invest $1.5B in Two New Manufacturing Sites

A series of cardiometabolic-related news items have been observed: Insulet announced FDA has cleared its Omnipod 5 for T1DM patients ≥ 6 years of age; BI/Lilly announced Jardiance (empagliflozin) has received a positive CHMP opinion for extension of indication to add the treatment of patients with HFpEF; Provention hosted a call with investors to provide additional details on the teplizumab BLA resubmission as well as teplizumab LCM initiatives (listen here); and Lilly announced plans to invest over $1.5B in two new manufacturing sites in Concord, North Carolina, and Limerick, Ireland. 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

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Libre 3 Filed as iCGM in US; Abbott Q4 ’21 Earnings Update; FDA Warns Lilly for Misleading Trulicity Instagram Promo

Two cardiometabolic-related news items have been observed: Abbott hosted its Q4 ’21 earnings call (press release; view infographic) where it disclosed it filed the Libre 3 CGM with FDA in 2021; and FDA’s Office of Prescription Drug Promotion (OPDP) has issued a letter to Lilly regarding misleading Trulicity social media post (view OPDP letter here; view Trulicity Promo Materials here). 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.

Lilly Partners with Abbisko Therapeutics and Evotec; Novo Partners with EraCal Therapeutic; Fractyl Announces Initial Interim Feasibility Data

A series of cardiometabolic-related news items have been observed: Abbisko Therapeutics announced it has entered into a worldwide collaboration and exclusive licensing agreement with Lilly for the development of novel cardiometabolic therapies; Evotec announced a three-year drug discovery collaboration with Lilly for metabolic diseases focusing on kidney diseases and diabetes; EraCal Therapeutics announced a research collaboration with Novo Nordisk for development of anti-obesity pharmacotherapy; and Fractyl Health announced initial interim feasibility data from its open-label REVITA-T2Di trial. 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.

JPM 2022 Day 2: LLY, ABT, AMRN, SNY, AMGN, RHHBY, and TEVA

On the second day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Lilly, Abbott, Amarin, Sanofi, Amgen, Roche, and Teva. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage

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 Hosts 2021 Investment Community Meeting

Lilly hosted its 2021 Investment Community Meeting (view presentation replay; view diabetes/obesity slides). During the event, Lilly highlighted a new strategy to expand its focus beyond diabetes to include obesity-related diseases (e.g. CV, liver, and kidney) by leveraging tirzepatide’s best-in-class profile. As part of the update, Lilly also provided an overview of the Ph3 QW insulin program as well as an overview of its early CVRM pipeline assets. Below, FENIX provides highlights and insights from the call.

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 Partners with Regor Therapeutics for Metabolic Drug Discovery

Lilly announced it has entered into a multi-year research agreement with Regor Therapeutics Group for the discovery, development, and commercialization of novel therapies for metabolic disorders. For context, Regor Therapeutics Group (view website) is a Chinese-based pharma company using Computer Accelerated Rational Discovery (CARD) to develop new medicines. Interestingly, the press release states, “Regor’s technology will also allow Lilly to further accelerate innovation and deliver breakthrough therapies in obesity and diabetes,” suggesting the partnership is broader than obesity and diabetes. Below, FENIX provides thoughts and insights on the Regor partnership.

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.