Tag Archives: Lilly

FDA Accepts IND for Lilly/Dicerna Cardiometabolic Asset; Gilead/Novo Announce Ph2 PoC NASH Results; Biocorp Launches Mallya in Europe; Nemaura Q3 ’20 Earnings Update; Diabeloop Partners for AID System in Japan

A series of diabetes-related news items have been observed: Dicerna announced FDA accepted Lilly’s IND application for a novel, unknown cardiometabolic asset, LY3561774; Gilead and Novo Nordisk announced positive results from a Ph2 PoC trial evaluating Novo’s semaglutide in combination with Gilead’s investigational FXR agonist and/or its ACC inhibitor for the treatment of NASH; Biocorp announced the launch of its Mallya insulin connected cap in Europe via a partnership with cgmDiabet; Nemaura Medical announced its CY Q3 ’20 (FY Q2 ’21) earnings; and Diabeloop and Terumo Corporation announced a partnership for the joint development of an AID system and exclusive distribution rights in Japan. Below, FENIX provides highlights and insight for the respective news items including curious questions on the Dicerna target split between Lilly-Novo and semaglutide Ph3 combos in NASH.

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 Invests in Early-Stage Glucose-Responsive Insulin Company; Novo Presents Full STEP 3 Results; Lifescan Hires New Head of Marketing; New CymaBay GPR119 Hypo Prevention Trial

A series of diabetes-related news items have been observed: Lilly invests in Protomer Technologies, a company developing novel drug therapies, including glucose-responsive insulin (view press release); Novo presents full data from the STEP 3 semaglutide obesity study at the 2020 Obesity Week conference (view press release); Lifescan hires Lisa Rose as the new Chief Marketing Officer (view press release); and CymaBay announced its GPR119 agonist will be evaluated in a T1DM hypo prevention study at Richard Pratley’s Translational Research Institute (view press release). Below, FENIX provides highlights and insights from 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, Novartis, Pfizer, and Merck Q3 ’20 Earnings Updates

Lilly, Novartis, Pfizer, and Merck each hosted their respective Q3 ’20 earnings calls and provided updates across a variety of topics. Importantly, it was disclosed that FDA has requested an advisory committee meeting to discuss Novartis’s Entresto PARAGON-HF submission. Below, FENIX provides highlights and insights from the respective 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.

BI Partners With Yale for HF Digital Solutions Trial; New Lilly Lyumjev T1DM TIR Study; Roche Q3 ’20 Earnings Update

A series of diabetes-related news items have been observed: Boehringer Ingelheim and Yale announced a collaboration to evaluate heart failure digital technologies (press release); Lilly initiated new Lyumjev (ultra rapid-acting lispro) + degludec U100 T1DM MDI TIR study; and Roche hosted its Q3 ’20 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items, including thoughts on how the new Lilly Lyumjev trial likely relates to the recent educational partnership between Lilly and Dexcom (previous FENIX insight).

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 Dexcom Partner to Promote Lyumjev and G6 CGM; Omar Ishrak to Retire from Medtronic; Patia BioPharma and Precision Diabetes Partner for Diabetes Diagnostics; Capillary Bio Receives $1.5M Loan from Helmsley

A series of diabetes-related news items have been observed: Lilly and Dexcom announced a partnership to launch a joint program for US HCPs, focusing on Lyumjev and G6 CGM’s role in PPG control; Medtronic announced its former CEO, Omar Ishrak, will retire as Executive Chairman and Chairman of the Board, succeeded by CEO, Geoff Martha; Patia Biopharma and Precision Diabetes announced a partnership for diabetes diagnostics; and Capillary Biomedical announced it has received a $1.5M loan from the Helmsley Charitable Trust to conduct trials for an extended-wear infusion set. Below, FENIX provides highlights and insights from 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.

Apple Cites T1DM Omnipod Patient Story at Tuesday Event; Jardiance Post-MI Trial (EMPACT-MI) Receives FDA FTD; Adocia Topline Results from M1Pram Ph1b Trial Extension; Welldoc/UMD Employs AI to Identify Digital Health Habits; Oramed’s Positive Diabetes Market Survey Results; Diamyd Receives $13.9M Towards Companion Medical Shares

A series of diabetes-related news items have been observed: Apple featured a T1DM patient story during the Apple Watch portion of its event; BI/Lilly announced Jardiance has received Fast Track designation for its EMPACT-MI study; Adocia announced positive topline results from its Ph1b M1Pram extension study in PWT1D; Welldoc and the University of Maryland’s Center for Health Information and Decision System (CHIDS) announced findings from a user engagement analysis; Oramed announced results from a diabetes market survey; and Diamyd received $13.9M from its divestment in Companion Medical. Below, FENIX provides highlights and insights from 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.

High-dose Trulicity, DAPA-HF and Gvoke up for Opinions; CHMP Agenda September 14-17

The CHMP agenda for this month (September 14-17) has been released, and it includes three notable items: high-dose Trulicity, Dapa-HF, Xeris’s Gvoke, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the September 2020 CHMP agenda.

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.

Thoughts on Newly Permanent Lilly Insulin+Baqsimi Copay Cards; New Novo+ACC ASCVD Registry; ProSciento Receives VC Investment

A series of diabetes-related news items have been observed: Lilly permanently committed to the Insulin Value Program $35 copay card besides other savings options for Humulin R U500 and Baqsimi; Novo Nordisk and ACC are launching a new ASCVD T2DM registry; and ProSciento closed a venture capital funding round. Below, FENIX provides an overview of the respective news items as well as thoughts on the economic benefit of the $35 insulin copay card compared to Semglee in addition to how the ACC partnership is beneficial to Novo.

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.

New Tirzepatide + Glargine U100 vs. Basal-Bolus Trial (SURPASS-6)

A new CT.gov record has been observed for a Lilly-sponsored Ph3 trial (SURPASS-6) comparing the safety and efficacy of tirzepatide vs. insulin lispro U100 in T2DM patients inadequately controlled on glargine U100 with or without metformin. Below, FENIX provides an overview of SURPASS-6 as well as insight into why the trial makes sense in the context of similar LCM trials conducted for Ozempic, Trulicity, Tanzeum, and Bydureon.

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.

High-dose Trulicity Approved by FDA

Lilly announced FDA approval of high-dose Trulicity (3.0 and 4.5mg; view updated label here) which is in-line with FENIX’s projection of August-September 2020 (previous FENIX insight). Per the updated Trulicity label, patients requiring additional glycemic control can uptitrate to the 3.0mg Trulicity dose after 4 weeks on the 1.5mg dose. An additional 4 weeks on the 3.0mg dose is required before moving to the 4.5mg dose. Below, FENIX provides an overview of the high-dose Trulicity label update and additional thoughts its approval.

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.