Tag Archives: Oramed

CHMP Denies Mounjaro OSA Indication; FLOW Positive CHMP Opinion; New Oramed Oral Insulin Study; Diamyd and FDA Align on Accelerated Approval; Noom to Offer Metformin for Weight Loss

A series of cardiometabolic-related news items have been observed from CHMP, Oramed, Diamyd Medical, and Noom. 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.

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AZ Q4 ’22 Earnings; Oramed to Consider M&A Opportunities

Two cardio-metabolic related news items have been observed: AstraZeneca hosted its Q4 ’22 and FY ‘22 earnings call and provided brief updates to its CVRM business, including the ongoing Farxiga LCM initiatives (press release; slides); and Oramed issued an update to shareholders (view here) in which it said the company is conducting a comprehensive analysis of the data from its discontinued Ph3 oral insulin trials. Below, FENIX provides highlights and insights into the respective news items, including thoughts on AZ’s dapa LCM initiatives ahead of its anticipated 2025 LOE.

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.

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.

Medtronic CY Q3 ’22 Earnings Update; Novo Expands Manufacturing Facilities; FDA Approves Lilly’s Rezvoglar as an Interchangeable Biosimilar; Oramed Presents Additional Ph2 PRMD-0801 NASH Data

Four cardio-metabolic related news items have been observed: Medtronic hosted its CY Q3 ’22 earnings call (press release; slides); Novo announced plans to invest DKK 5.4B (~$750M USD) in the expansion of manufacturing facilities in Denmark (view press release); FDA approved Lilly’s Rezvoglar (bs-glargine) as an interchangeable to Sanofi’s Lantus (view label; view article); and Oramed hosted an event to discuss data from its Ph2 trial evaluating 8mg ORMD-0801 compared to placebo in 32 participants with T2DM and NASH (slides; webcast; press release). 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.

Akero Becomes a Frontrunner in NASH; Lilly Initiates Tirzepatide Ph2 TREASURE-CKD Trial; Oramed’s Oral Insulin Ph2 NASH Topline Results

Three cardiometabolic-related news items have been observed: Akero announced positive topline results from its Ph2b HARMONY trial evaluating QW efruxifermin (EFX) in pre-cirrhotic NASH (view CT.gov record); Lilly’s Ph2 tirzepatide CKD trial (TREASURE-CKD) has been observed (view CT.gov record); and Oramed announced positive topline results from its Ph2 trial evaluating ORMD-0801 in T2DM and NASH. 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.

vTv Receives $10M Investment from CinPax, LLC; Oramed Reaches 50% Enrollment in Second Ph3 Oral Insulin Trial; Esperion Establishes Scientific Advisory Board

Three cardiometabolic-related news items have been observed: vTv announced it received a $10M investment from CinPax; Oramed announced it has reached over 50% enrollment in its second Ph3 oral insulin trial in T2DM; and Esperion established a Scientific Advisory Board to support pipeline and LCM initiatives. 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

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Bayer Presents New Finerenone Analysis; Lilly to Invest $2.1B in Additional Manufacturing Capacity; Oramed Granted Combination Therapy Patent for Oral GLP-1+Insulin

Three cardiometabolic-related news items have been observed: During the ESC’s 2022 HF Congress, Bayer presented late-breaking data from an exploratory FIDELITY post hoc analysis; Lilly announced plans to invest $2.1B in new Indiana manufacturing sites; and Oramed recently announced it has been granted a US patent for its oral GLP-1RA+insulin combination therapy in 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.

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 Genesis Therapeutics Collaboration; Esperion Q1 ’22 Earnings Update; Oramed’s Pivotal Ph3 Oral Insulin Trial Completes Enrollment; MySugarWatch Launches HCP-focused Ad Campaign for sugarBEAT in MIMS

A series of cardiometabolic-related news items have been observed: Genesis Therapeutics announced a strategic collaboration with Lilly; Esperion (press release; slides) hosted its Q1 ‘22 earnings call; Oramed announced the Ph3 study (ORA-D-013-1) of its oral insulin capsule (ORMD-0801) in T2DM has completed enrollment; and Nemaura Medical announced that its UK licensee, MySugarWatch, has launched a series of ads in MIMS as part of a large-scale awareness campaign for the company’s sugarBEAT non-invasive CGM. 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.

EMPA-KIDNEY Stopped Early; Bayer Files FIGARO-DKD in EU; Glooko Acquires DIABNEXT; Oramed Completes Ph2 Oral Insulin NASH Enrollment; Better Therapeutics Announces BT-001 Pivotal Trial Data in T2DM

A series of cardiometabolic-related news items have been observed from BI/Lilly, Bayer, Glooko, Oramed, and Better Therapeutics. 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 CY Q3 ’21 (FY Q2 ’22) Earnings Update; HAGAR’s GWave Receives Breakthrough Device Designation; Oramed Randomizes 75% of Patients in Oral Insulin Trial; Beyond Type 1 Launches Web Platform in Arabic

A series of cardiometabolic-related news items have been observed: Medtronic hosted its CY Q3 ’21 (FY Q2 ’22) earnings call (press release; slides); HAGAR announced that its non-invasive CGM (GWave) has received Breakthrough Device Designation; Oramed announced it has enrolled and randomized 75% of the 675 T2DM patients in its Ph3 trial (ORA-D-013-1) evaluating its oral insulin; and Beyond Type 1 announced it has launched its web platform in Arabic. 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.