Tag Archives: Provention Bio

Intarcia Files Notice of Opportunity for a Hearing; Provention Bio Advances popPK Model for Teplizumab; Zealand Announces Dapiglutide Topline Results

Three cardiometabolic-related news items have been observed: It has been reported that Intarcia Therapeutics has filed for a Notice of Opportunity for a Hearing with FDA for ITCA-650 (link to WSJ article); Provention Bio announced topline results from preliminary analysis of popPK model; and Zealand announced topline results for Ph1b trial with GLP1-GLP2 dual receptor agonist (dapiglutide). 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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Bayer and Senseonics Q3 ’21 Earnings Updates; Abbott and ADA Launch Community Initiative; Provention Bio Launches #Type1TestedPledge Campaign; Beyond Type 1 Receives $750,000 Grant

A series of cardiometabolic-related news items have been observed: Bayer (press release; slides) and Senseonics (press release) hosted their respective Q3 ’21 earnings calls; Abbott and the American Diabetes Association (ADA) announced the launch of their first joint community initiative in Columbus, Ohio; Provention Bio announced the launch of its #Type1TestedPledge Campaign for Diabetes Awareness Month; and Beyond Type 1 announced it has received a $750,000 Grant from the Helmsley Charitable Trust. Below, FENIX 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.

Viatris’s Semglee Gains Preferred Status on Prime Therapeutics’s National Formularies; Zealand’s First Patient Dosed with ZP8396 in Ph1 Trial for Obesity; Insulet, Lannett, Ionis, Provention Bio, BD, and Regeneron Q3 ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed from Prime Therapeutics, Zealand, Lannett, Ionis, Provention Bio, Becton Dickinson, Regeneron, and Dario. 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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Purchase Blast$599.00

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

September 13-16 CHMP Agenda; Dexcom Exec Joins iRhythm as CEO; Provention Teplizumab Update

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month (September 13-16) has been released; iRhythm announced Quentin Blackford, outgoing Dexcom COO, will join the company as President and CEO, effective October 4, 2021; and Provention Bio issued an update on the BLA resubmission of teplizumab to delay the onset of T1DM in at-risk individuals (press release). 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.

Novo Buys Cardiomyopathy Asset From Prothena; Teplizumab Receives UK Innovation Passport; Poxel Reorganizes Strategic Direction; Dario Announces New Employer Contracts; New Generic Sitagliptin Received Tentative Approval

Five cardiometabolic-related news items have recently been observed: Novo Nordisk and Prothena Corporation announced a definitive purchase agreement in which Novo has acquired Prothena’s clinical-stage antibody PRX004 and broader ATTR amyloidosis program; Provention Bio announced teplizumab was awarded an “Innovation Passport” in the UK for the delay of clinical T1DM in at-risk diabetes; Poxel announced a new strategic direction for its pipeline which focuses on high value, rare metabolic indications and NASH; Dario announced three new employer contracts; and Unichem Laboratories Limited announced tentative FDA approval of its generic sitagliptin. 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.

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.

Novartis Resubmits Inclisiran NDA; Provention Bio Receives CRL for Teplizumab

Two cardiometabolic-related news items have been observed: Novartis announced the inclisiran NDA has been resubmitted to FDA and Provention Bio announced it received a CRL from FDA for the teplizumab BLA citing the need for additional data regarding PK comparability. Of note, the Provention Bio CRL did not cite any clinical deficiencies related to the efficacy and safety data packages and confirmed the acceptability of the proposed proprietary name for teplizumab, Tzield. 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

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

Lilly Debuts Connected Pen at ATTD; ATTD 2021 Key News (June 3)

On Day 2 of ATTD 2021, a series of diabetes-related press releases and presentations have been observed from Lilly, Dexcom, Senseonics, and Provention Bio. Importantly, Lilly hosted a Symposium at ATTD dedicated to its new connected pen platform in which the company (for what is believed to be the first time) displayed the Tempo Smart Button device. 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.

Teplizumab Adcom: 10-7 Split Vote; Questions Raised on Teplizumab’s Approvability

Today, FDA held an advisory committee meeting to discuss the proposed teplizumab indication to delay the onset of T1DM based on results from the TN-10 study. The panel narrowly voted in favor (10-7) that the teplizumab benefits outweigh the risks. Recall, ahead of the adcom, FENIX correctly predicted a 10-7 vote favoring teplizumab. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for Provention Bio and teplizumab.

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 Connected Pen Update; Novo Q1 ’21 Post-earnings Event; Provention Bio, BD, ICPT, and REGN Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly provided an update on its connected pen development, including the disclosure of the Tempo Smart Button (view press release); Novo Nordisk hosted its post-Q1 ’20 earnings event (see previous FENIX insight on Q1 ’21 Novo earnings from May 5); Provention Bio (press release), Becton Dickinson (press release), Intercept (press release; slides) and Regeneron (press release) hosted their respective CY Q1 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items, including thoughts on BD’s decision to spin off its diabetes business.

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 Novartis Q1 ’21 Earnings Updates; New Trulicity TV DTC; Provention Meets with FDA

A series of cardiometabolic-related news items have been observed: Lilly and Novartis hosted their respective Q1 ’21 earnings calls; Lilly has initiated a new Trulicity DTC campaign; and Provention Bio announced it met with FDA on April 23, 2021 to discuss the ongoing teplizumab PK comparability issue. Importantly, Lilly disclosed that SURPASS-4 has accrued all of its pre-specified CV events and the trial is scheduled to close out in May with topline results expected by the end of Q2 ’21. Recall, Lilly has previously stated SURPASS 4 is the gating factor for tirzepatide T2DM global regulatory submissions later in 2021. Below, FENIX provides highlights and insights for the respective 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.