Tag Archives: Diabetes

Daprodustat US approval in question after vada CRL; Akebia post-CRL investor call highlights

Following the vadadustat CRL issued on March 30, 2022, Akebia hosted a call with investors to discuss the steps forward. Below FENIX provides highlights and insights from the call, including readthrough to GSK’s daprodustat.

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.

Zealand Restructures Business to Focus on R&D and Cuts 90% of US Workforce; Samsung and JDRF T1DM Invest in Jaguar Gene Therapy

Two cardiometabolic-related news items have been observed: Zealand announced a company restructuring comprised of a shift back toward an R&D organization, a CEO transition, and a 90% US workforce reduction (listen to call investor call here); and Jaguar Gene Therapy announced Samsung Ventures and the JDRF T1D Fund have invested in the company. 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.

Otsuka/Akebia receive vadadustat CRL

Akebia announced the FDA has issued a CRL regarding the vadadustat NDA for the treatment of anemia due to CKD. According to the press release, FDA concluded that the data in the NDA “do not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients.” FDA expressed safety concerns including failure to meet non-inferiority in MACE in the non-dialysis patient population, increased risk of thromboembolic events, driven by vascular access thrombosis in dialysis patients, and the risk of drug-induced liver injury. Additionally, in the CRL, FDA suggested that Akebia investigate ways to potentially demonstrate a favorable benefit-risk assessment through new clinical trials. Akebia will be working with its partners to evaluate the CRL, and it intends to request a meeting with FDA to evaluate next steps. Importantly, Akebia will host a conference call Wednesday, March 30 at 6:00 PM ET to discuss the CRL.

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.

Vadadustat PDUFA Passed?

The vadadustat PDUFA date was on March 29, 2022; however, no press releases have been observed by Otsuka/Akebia nor has anything been posted on Drugs@fda. As such, it remains unclear if FDA will still approve the NDA in the coming days, issue a CRL, or potentially extend the PDUFA date. Presumably, the companies will have to issue a press release once they officially hear from FDA. Below, FENIX provides brief thoughts on the missed PDUFA date.

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 Initiates Bs-glargine Pivotal Trial; Tirzepatide Meta-analysis Shows No Increased MACE Risk in T2DM; Provention Bio’s PRV-101 Vaccine Positive Final Results

A series of cardiometabolic-related news items have been observed: Lannett announced the initiation of its biosimilar insulin glargine pivotal trial; A CV safety meta-analysis for the tirzepatide Ph3 SURPASS program was published in Nature Medicine and showed no increased MACE risk in T2DM (view publication); and Provention Bio announced PRV-101 vaccine positive final results (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.

Dexcom to Implement 4:1 Stock Split; Libre Reimbursed in Japan for Basal-Only Patients; Ypsomed/CamDiab Ltd Collaboration; Movano Q4 ’21 and FY ‘21 Earnings Update

A series of cardiometabolic-related news items have been observed: Dexcom announced that the company’s Board of Directors has approved a four-for-one forward split of Dexcom’s common stock; Abbott announced the Japanese Ministry of Health, Labor and Welfare has approved reimbursement coverage for Libre in basal-only patients; Ypsomed announced a partnership with CamDiab Ltd for AID system development; and Movano hosted its Q4 ’21 earnings call (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.

Supersapiens Energy Band Review Published in Rouleur; Arecor Granted US Patent for Insulin Products; 9am.health and Ascensia Collaboration

A series of cardiometabolic-related news items have been observed: A review of the Supersapiens Energy Band Version Zero has been published in a well-known British cycling magazine (view review here); Arecor announced it has been granted patent US11278624 by the US Patent and Trademark Office protecting novel formulations of insulin products AT247 and AT278; and 9am.health announced Ascensia’s CONTOUR NEXT ONE blood glucose meter and CONTOUR NEXT test strips are now available to its prediabetes and T2DM patients. 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.

Abbott Sponsors YouTube Video; Novo-Novartis Generic Victoza Suit Settled; Dario Q4 and FY ’21 Earnings; Signs Two New Employer Contracts

A series of cardiometabolic-related news items have been observed: An Abbott-sponsored YouTube video highlighting several of Abbott’s devices was recently posted by YouTube creator UrAvgConsumer (view video); it has been reported that Novo Nordisk and Novartis’s Sandoz have settled their generic Victoza patent infringement lawsuit (view article); and Dario hosted its Q4 and FY ’21 earnings call (press release) and announced two additional new employer contracts (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.

Teplizumab BLA Re-submission Accepted by FDA; March 21-24 CHMP Agenda

Two cardiometabolic-related news items have been observed: Provention Bio announced FDA has accepted the resubmitted teplizumab BLA for the delayed onset of T1DM; and the CHMP agenda for this month’s meeting (March 21-24) has been released. 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.

Medtronic Appoints New Diabetes EVP and Operating Unit President; Lexicon Loan Suggests No Priority Review for Sota; Diamyd Opens First EU Clinic for Ph3 DIAGNODE-3 Trial; Xeris Launches Gvoke Kit in US; DiaMedica Q4 and FY ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: Medtronic announced leadership transitions for three of its operating units including diabetes, surgical robotics, and cardiac rhythm management; Lexicon announced it has entered into a loan facility agreement with Oxford Finance, providing up to $150M in borrowing capacity; Diamyd announced it has opened the first clinic in EU for initiation of its Ph3 DIAGNODE-3 trial in T1DM; Xeris announced it has launched its Gvoke Kit RTU glucagon (1mg/0.2 mL single-dose vial and syringe kit) in the US; and DiaMedica hosted its Q4 and FY ’21 earnings (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.