Tag Archives: Invokana

SELECT up for CHMP Opinion?; April CHMP Agenda; BI Partners for MASH; Lilly Acquires Nexus Manufacturing Site

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (April 22-25) has been released and SELECT is likely up for an opinion (view CHMP agenda); Ochre announced it entered into a partnership with BI for liver disease (view press release); and Lilly announced an agreement to acquire an injectables manufacturing facility from Nexus Pharmaceuticals (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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Novo Partners for Oral Obesity Asset; Scholar Rock Announces IND Clearance for Obesity; JNJ Q4 ’23 Earnings

Three cardiometabolic-related news items have been observed: Novo Nordisk entered a collaboration and licensing agreement with EraCal for its oral, small molecule asset for obesity (view press release); Scholar Rock announced IND clearance to initiate Ph2 PoC trial with its myostatin inhibitor for obesity (view press release); and J&J hosted its Q4 ’23 earnings call (press release; slides). 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.

Medtronic Terminates EOFlow Acquistion; t:slim X2 Now Available with Dexcom G7 Integration; Indoco Receives Tentative Approval for Generic Invokana

Three cardiometabolic-related news items have been observed: Medtronic announced it has terminated the EOFlow acquisition (view SEC filing); Dexcom (view press release) and Tandem (view press release) announced the launch of updated t:slim X2 insulin pump software with Dexcom G7 CGM integration in the US; and FDA granted Indoco Remedies a tentative ANDA approval for generic canagliflozin (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on why Medtronic’s decision to terminate the EOFlow deal makes sense.

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.

Resmetirom Receives Breakthrough Therapy Designation; Tiziana Initiates Foralumab T1DM Program; Teladoc Expands Provider-Based Care; J&J Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Madrigal announced resmetirom received Breakthrough Therapy Designation (BTD) from FDA for the treatment of NASH with liver fibrosis (view press release); Tiziana Life Sciences announced it is initiating a program to develop intranasal foralumab for the treatment or prevention of T1DM (view press release); Teladoc Health announced the expansion of its Provider-Based Care for weight management and prediabetes programs (view press release); and Johnson & Johnson hosted its Q1 ’23 earnings call (press release; slides). 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.

Lannett Announces Positive Pivotal Bs-Glargine Results; Mark Cuban’s Pharmacy Offers Janssen’s Invokana; Diamyd Partners with JDRF for Ph3 Diamyd T1DM Development

Three cardiometabolic-related news items have been observed: Lannett announced topline results from its bs-glargine U100 pivotal study (view press release; view CT.gov record); Mark Cuban Cost Plus Drug Company (view website) announced it is now offering Janssen’s Invokana, Invokamet, and Invokamet XR (view tweet); and Diamyd Medical announced it entered into a four-year research and development collaboration with JDRF to support its ongoing Ph3 DIAGNODE-3 trial in T1DM (view press release). Below, FENIX provides highlights and insights into the respective news items including potential readthrough from recent insulin price reductions announced by Lilly, Novo, and Sanofi to Lannett’s bs-glargine.

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 CY Q4 ’22 Earnings; Arrowhead Regains Rights to NASH Asset; Zydus Receives Tentative Approval for Generic Invokana

Three cardiometabolic-related news items have been observed: Biocon hosted its FY Q3 ’23 (CY Q4 ’22) earnings call (view press release) and disclosed plans to develop a generic tirzepatide; Arrowhead Pharmaceuticals announced it has regained rights to ARO-PNPLA3, formerly JNJ-75220795, which was being developed in collaboration with Janssen for the treatment of NASH (view press release); and FDA granted tentative approval for Zydus Pharmaceutical’s generic canagliflozin (Invokana; view Drugs@FDA). Below, FENIX provides highlights and insights from the respective news items, including brief thoughts on the potential timing of Biocon’s generic tirzepatide.

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.

Dario Included in Vitality’s Gateway Flex Program; J&J Q3 ’20 Earnings Update

Dario announced it has been chosen for inclusion in Vitality’s new Gateway Flex offering. J&J also hosted its Q3 ’20 earnings call (press release; slides), and unsurprisingly, there was significant discussion surrounding the recent pause on J&J’s COVID-19 vaccine trial due to an unknown illness in one of the trial participants (view statement from J&J). Below, FENIX provides insight into the impact of Gateway Flex on Dario’s business as well as diabetes-related financial highlights from the J&J earnings 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.

Invokana Boxed Warning Removed

The Invokana franchise US labels have been updated (view Invokana label here), and the Boxed Warning for lower limb amputations has been removed. However, it should be noted that warnings for lower limb amputations are still listed under “warnings and precautions.” Below, FENIX provides an overview of the Invokana franchise label updates as well as thoughts on the impact of the Boxed Warning removal.

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.

CREDENCE Approved by EC

Late yesterday, Janssen’s EU partner, Mundipharma, announced the European Commission approved the Invokana renal protection indication based on results from the CREDENCE  renal outcomes study (view the updated summary of product characteristics here). Recall, CREDENCE received a positive CHMP opinion on May 29, 2020 (previous FENIX insight). Below, FENIX provides brief thoughts on the EC approval and expanded market potential.

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.