Category Archives: GLP-1RA

Lilly Launches Educational Initiative; Thane Wettig Joins FibroGen; Tandem Acquires Sugarmate; BI Doses First Patient in Ph2 Dual-agonist Trial; IM Therapeutics Doses First Patient with Novel T1DM Therapy

Five diabetes-related news items have been observed: Lilly initiated a hypoglycemia awareness campaign; former Lilly and Intarcia executive, Thane Wettig, joins FibroGen; Tandem announced the acquisition of Sugarmate; and more. Below, FENIX provides highlights and insights 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.

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DAPA-HF CHMP Opinion This Week?; CHMP Agenda June 22-25

The CHMP agenda for this month (June 22-25) has been released, and it includes one notable item, a potential DAPA-HF CHMP opinion, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the June 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.

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Purchase Blast$599.00

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Novo Reports Impressive AM833 Ph2 and AM833+sema Ph1 Topline Results

Novo Nordisk announced positive topline results for its Ph2 AM833 and Ph1 AM833+semaglutide trials, both for the treatment of obesity. Novo previously disclosed AM833 has been given the INN of “cagrilintide.” Recall, on June 12, 2020, Novo reported topline results from the final two trials in its Ph3 semaglutide obesity program (previous FENIX insight). Below, FENIX provides an overview of the topline data as well as brief thoughts on AM833 in the context of Novo’s injectable semaglutide Ph3 obesity program.

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.

Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE at ADA 2020; Sota T2DM CKD Data; vTv Presents TTP399 Ph2 Results; ADA 2020 Key Press Releases (June 13)

Today, nine diabetes-related news items were observed: Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE data were presented at ADA 2020 as well as new data from Lexicon (sota T2DM Ph3 CKD), vTv (Ph2 Simplici-T1), and Zealand (V-Go patch pump). Below, FENIX provides context and analysis for the announcements.

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.

Semaglutide Ph3 Obesity Positive Topline Results (STEP 1)

Novo Nordisk announced positive topline results from the Ph3a STEP 1 trial evaluating the safety and efficacy of QW sc semaglutide 2.4mg on body weight (press release). Recall, STEP 1 is the second of the STEP trials to read out following STEP 4 in May (previous FENIX insight). Below, FENIX provides an overview of the STEP 1 results and the consistency with STEP 4.

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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CREDENCE Receives Positive CHMP Opinion; Metformin ER Recalled Over NDMA Impurities

Two diabetes-related news items have been observed: according to the CHMP meeting highlights, Janssen’s Invokana/Vokanamet renal protection indication (CREDENCE) has received a positive CHMP opinion and FDA announced a voluntary recall for certain lots of metformin ER due to nitrosamine impurity N-Nitrosodimethylamine (NDMA) impurities. Of note, FDA indicated there are five firms who have been contacted about the recall but additional manufacturers remain unaffected. Below, FENIX provides brief thoughts on the the CREDENCE CHMP opinion and insight on a potential readthrough to branded OADs following the metformin recall.

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 Once Again on the CHMP Agenda; CHMP Agenda May 25-28

The CHMP agenda for this month’s meeting (May 25-28) has been released, and it includes two notable items: the Invokana/Vokanamet renal protection indication (CREDENCE) and the Saxenda adolescent label extension. Of note, the May 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started on May 25. Below, FENIX provides diabetes-related highlights and insights from the May 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.

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Purchase Blast$599.00

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

Thoughts on High-dose Trulicity Data

Late last week, Lilly announced that results from the AWARD-11 high-dose Trulicity trial had been published, with data showing up to -1.9% reduction in A1C and -10.4lb weight loss at 36 weeks with the 4.5mg dulaglutide dose (previous FENIX insight). Below, FENIX has conducted an AWARD-11 comparative analysis and provides thoughts on high-dose Trulicity in the context of Novo’s Ozempic and Lilly’s 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.

Sanofi to Return Efpeg Rights To Hanmi

Sanofi has reportedly informed Hanmi of its intention to return efpeglenatide rights back to Hanmi. Hanmi noted that the two companies have 120 days to renegotiate the efpeglenatide deal at which point Hanmi said it may be open to taking legal action against Sanofi if needed. Below, FENIX provides insight into Sanofi’s decision, the potential impact on the efpeg development program, and why efpeg is still an attractive option for treating NASH/obesity.

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.

Semaglutide Ph3 Obesity Positive Topline Results (STEP 4)

Yesterday, Novo Nordisk announced positive results from the Ph3a STEP 4 trial evaluating the safety and efficacy of Semaglutide 2.4mg on body weight. Recall, STEP 4 is the first of the Ph3 semaglutide obesity program trials to read out. Below, FENIX provides an overview of the results as well as thoughts on potential readthrough to high-dose Ozempic.

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.