Tag Archives: CHMP agenda

Pfizer Hosts 2022 R&D Day; Novo Initiates 7.2mg Sema Ph3 Obesity Trial; ADA 2023 Diabetes SoC Guidelines; December CHMP Agenda

A series of cardiometabolic-related news items have been observed: Pfizer hosted a Near-Term Launches and High-Value Pipeline investor event and discussed its two oral GLP-1RAs, PF-07081532 and danuglipron (slides; webcast); Novo Nordisk initiated a Ph3 semaglutide obesity trial evaluating up to a 7.2mg QW subcutaneous dose (STEP UP; view CT.gov record); ADA announced it published the 2023 SoC guidelines in Diabetes Care (view press release; view publication); and the CHMP agenda (view here) for this month’s meeting (December 12-15) has been released. Below, FENIX provides insight on the respective news items, including the impact of the updated ADA Standards of Care guidelines.

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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Lilly Connected Pen US Launch in 2022; Lannett Partners with Ypsomed; Eversense to Integrate with Apple; Viatris Q3 ’22 Earnings Update; November CHMP Agenda

A series of CVRM-related news items have been observed: Lilly announced plans to launch its Tempo Personalized Diabetes Management Platform to select US clinics in 2022; Lannett announced a partnership with Ypsomed for insulin pen delivery; Ascensia announced the Eversense implantable CGM now integrates with Apple Health; Viatris hosted its Q3 ’22 earnings and provided brief updates to its bs-insulin portfolio divestiture (press release; slides); and the November CHMP agenda (view here) has been released. 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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Purchase Blast$599.00

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Indigo Expands Multi-Metabolite Sensor Development; GlucoTrack to Develop CGM for T1DM; AZ Initiates New Dapa + Zibotentan Ph2 Trial; Sciwind Initiates Patient Dosing in Ph1 Oral GLP-1RA Trial; Ascensia Completes Initial European E3 CGM Launch; October CHMP Agenda

A series of cardiometabolic-related news items have been observed from Indigo, GlucoTrack, AstraZeneca, Sciwind, Ascensia, and EMA. 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

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

Novo Partners with Microsoft for Drug Development; Novo Launches Unbranded Degludec; AZ Partners with Gatehouse Bio for HFpEF RNAi Therapeutic Development; September 2022 CHMP Agenda

Four cardiometabolic-related news items have been observed: Novo announced a partnership with Microsoft for drug development (view press release); Novo announced plans to launch an unbranded version of Tresiba (view press release); AZ partners with Gatehouse for HFpEF RNA-based drug development (view press release); the CHMP agenda for this month’s meeting (September 12-15) has been released and includes multiple cardiometabolic-related agenda items. 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.

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Purchase Blast$599.00

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

Tirzepatide up for CHMP Opinion; July 18-21 CHMP Agenda; Lilly Initiates QW Insulin T2DM MDI Trial (QWINT-4); UHC Eliminates Insulin OOP Costs

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (July 18-21) has been released and it appears Lilly’s tirzepatide is up for an opinion; a third trial from Lilly’s Ph3 QW insulin program (BIF; LY3209590) has been observed (view CT.gov record); and UnitedHealthcare announced that starting January 1, 2023, it will eliminate out-of-pocket costs for certain preferred prescription drugs, including insulin and four medical emergency drugs. 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.

Illinois Expands Insurance Coverage to Include CGMs; Adocia Announces Positive Top-line Results from Ph2 M1Pram Trial; June 20-23 CHMP Agenda

Three cardiometabolic-related news items have been observed; new Illinois law requires insurance and managed health plans to expand insurance coverage to include CGMs for people with T1DM and T2DM (view article); Adocia announced positive top-line results from its Ph2 trial (view CT.gov record) comparing M1Pram to Humalog in T1DM; and the CHMP agenda for this month’s meeting (June 20-23) 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.

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Purchase Blast$599.00

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

May 16-19 CHMP Agenda; Glyscend Therapeutics Completes Ph1 GLY-200 Trial in T2DM

Two cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (May 16-19) has been released; and Glyscend Therapeutics announced the completion of its single and multiple ascending dose (SAD/MAD) Ph1 GLY-200 trial 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.

Daprodustat NDA Accepted by FDA; Sean Saint Looks to Do It Again; April 19-22 CHMP Agenda; J&J Q1 ’22 Earnings Update

Several cardiometabolic-related news items have recently been observed: GSK announced FDA accepted the daprodustat NDA for the treatment of patients with anemia due to CKD; Sean Saint has started a new company called Luna Diabetes (view website); the CHMP agenda for this month’s meeting (April 19-22) has been released; and J&J hosted their Q1’ 22 earnings call (press release; slides). 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

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.

Provention Bio Refiles Teplizumab BLA; Medtronic and Tandem Q4 ’21 and FY ’21 Earnings Updates; Lilly Invests $700M in New Lilly Institute for Genetic Medicine; RosVivo Therapeutics and Lilly Sign MTA for RSVI-301; February 21-24 CHMP Agenda

A series of cardiometabolic-related news items have recently been observed from Provention Bio, Medtronic, Tandem, Lilly, RosVivo Therapeutics, and the CHMP. 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.