Tag Archives: CHMP

April 19-22 CHMP Agenda; EMPEROR-REDUCED Opinion?; Virta Health Raises $133M in Series E

Two cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (April 19-22, 2021) has been released and includes one notable item⁠, Jardiance HFrEF is listed under Type II Variations; and Virta Health announced it has raised $133M in a Series E equity financing round at a $2B valuation (up from $1.1B in December 2020). 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.

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Zealand’s Dasiglucagon Approved; March 22-25 CHMP Agenda; Fractyl Enrolls First Patient in T2DM Study; Twist Bioscience Announces Positive Preclinical Data

A series of cardiometabolic-related news items have been observed: Zealand’s dasiglucagon has been approved in the US as “Zegalogue” for the treatment of severe hypoglycemia in patients 6 years of age and older; the CHMP agenda for this month’s meeting (March 22-25, 2021) has been released; Fractyl announced the first patient has been enrolled in a pivotal trial of Revita DMR; and Twist Bioscience announced positive preclinical data in which its library identified GLP-1R antibodies that demonstrated glucose control. Below, FENIX provides highlights and insights from the respective news items, including thoughts on two potential generic sitagliptin products on the 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.

Adocia Reports Positive BC Lispro Data with Tonghua Dongbao Insulin; January 25-29 CHMP Agenda

A series of cardiometabolic-related news items have been observed: Adocia announced positive results from a BioChaperone Lispro trial using insulin sourced from Tonghua Dongbao; and the CHMP agenda for this month’s meeting (January 25-29, 2021) has been released, and it includes one notable item: EMPEROR-Reduced is on the CHMP agenda but not believed to be up for an opinion. 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.

Biocon/Mylan Bs-Aspart and Xeris Glucagon up for CHMP Opinions? CHMP Agenda December 7-10

The CHMP agenda for this month (December 7-10) has been released, and it includes two notable items, potential CHMP opinions for Biocon/Mylan’s insulin aspart and Xeris’s glucagon, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the December 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.

Nemaura Medical Q2 ’20 Earnings Update; Cecelia Health Secures $13M in Series B Funding

Two diabetes-related news items have been observed: Nemaura Medical announced its Q2 ’20 earnings (press release) and Cecelia Health announced a Series B funding round of $13M. Below, FENIX provides highlights and insight 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.

DAPA-HF CHMP Opinion This Week?; October 12-15 CHMP Agenda

The CHMP agenda for this month (October 12-15) has been released, and it includes one notable item, DAPA-HF, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the October 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.

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.

AZ to Withdraw Qtrilmet Marketing Authorization; CHMP Agenda August 17-20

The CHMP agenda for this month’s meeting (August 17-20) has been released, and it includes one notable item: Qtrilmet marketing authorization withdrawal. Of note, the August 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started on August 17. Additionally, the August CHMP meeting does not include oral explanations, only written procedures. Below, FENIX provides diabetes-related highlights and insights from the August 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.

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.

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 and Sanofi’s Bs-Aspart up for CHMP Opinion; CHMP Agenda April 28-30

The CHMP agenda for this month’s meeting (April 28-30) has been released, and it includes two notable items up for CHMP opinion: Invokana/Vokanamet renal protection indication (CREDENCE) and Sanofi’s bs-aspart initial application. Of note, the April 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started yesterday. Below, FENIX provides diabetes-related highlights and insights from the April 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.