Tag Archives: lannett

Novo Q1 ’22 London Earnings; Lilly Initiates Second Trial in Ph3 QWINT Program; Ionis, Provention Bio, Lexicon, and Lannett Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q1 ’22 earnings event (see previous FENIX insight on Q1 ’22 Novo earnings from April 29); a second trial from Lilly’s Ph3 QW insulin program (BIF; LY3209590) has been observed (view CT.gov record); Lexicon (press release), Ionis (press release; slides), Provention Bio (press release), and Lannett (press release) hosted their respective Q1 ‘22 earnings calls. 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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Lannett Initiates Bs-glargine Pivotal Trial; Tirzepatide Meta-analysis Shows No Increased MACE Risk in T2DM; Provention Bio’s PRV-101 Vaccine Positive Final Results

A series of cardiometabolic-related news items have been observed: Lannett announced the initiation of its biosimilar insulin glargine pivotal trial; A CV safety meta-analysis for the tirzepatide Ph3 SURPASS program was published in Nature Medicine and showed no increased MACE risk in T2DM (view publication); and Provention Bio announced PRV-101 vaccine positive final results (press release). 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.

Lannett, Merck, Roche, and BD Q4 ‘21 and FY ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lannett (press release), Merck (press release; slides), Roche (press release; slides), and BD (press release; slides) hosted their respective Q4 ’21 earnings calls. 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.

FDA Approves Lannett’s Bs-glargine IND; Biocon CY Q4 ’21 (FY Q3 ’22) Earnings Update

Two cardiometabolic-related news items have been observed: Lannett announced FDA has approved the IND application for Lannett’s bs-glargine; and Biocon hosted its Q4 ’21 (FY Q3 ’22) earnings call (press release). 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.

Novo Hosts Wegovy Shortage Call with Investors; Lannett Files Bs-glargine IND; Provention Adds New Management; Intercept NASH Data Delayed

A series of CVRM-related news items have been observed: Novo Nordisk hosted a call with investors to provide additional information and context on the recent announcement regarding its Wegovy supply constraints (view slides); Lannett announced it has filed an IND for its bs-glargine with the pivotal trial to begin in March 2022; Provention Bio announced it has expanded its executive team; and Intercept announced its Ph3 REVERSE trial topline data readout will be delayed to Q1 ’22. 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.

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.

Lannett CY Q2 ‘21 (FY Q4 ’21) Earnings Update

Lannett hosted its CY Q2 ’21 (FY Q4 ’21) earnings call in which it provided brief updates to its biosimilar glargine U100 and biosimilar aspart development programs. Of note, Lannett now anticipates filing the bs-glargine BLA in H1 ’23 (previously “later in 2022”) with a US launch planned for H1 ’24 (previously 2023). Below, FENIX provides highlights and insights from the call.

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.

Tandem, Lannett, Esperion, and Ionis Q1 ’21 Earnings Updates; Nemaura Receives Order for its Non-invasive CGM

A series of cardiometabolic-related news items have recently been observed: Tandem, Lannett, Esperion, and Ionis hosted their respective Q1 ’21 earnings calls; and Nemaura Medical announced it received an order from its UK licensee, DB Ethitronix Ltd, of 5,000 sugarBEAT transmitters and 200,000 sugarBEAT sensors. 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.

Lannett Receives FDA Feedback for Bs-glargine; Adocia Initiates Ph2 M1Pram Trial; Vertex Receives Fast Track Designation for VX-880 in T1DM; Welldoc Hires New CMO; Intercept CFO to Depart

A series of diabetes-related news items has been observed: Lannett announced it received FDA feedback regarding its biosimilar insulin glargine Ph3 program; Adocia announced the initiation of a Ph2 study evaluating M1Pram (pramlintide+insulin FRC) vs. Humalog in patients with T1DM; Vertex announced FDA granted Fast Track Designation to VX-880 for the treatment of T1DM; Welldoc announced the hiring of Marina Dorotheo as CMO; and Intercept announced the resignation of CFO, Sandip Kapadia. 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.

ViaCyte Initiates Ph2 Encapsulated Cell Therapy Trial in T1DM; Lannett, Merck, Roche, and BD Q4 and FY ’20 Earnings Updates; Merck CEO to Retire

A series of diabetes-related news items have been observed: ViaCyte announced the initiation of a Ph2 study of encapsulated cell therapy for the treatment of T1DM; and Lannett, Merck, Roche, and BD hosted their respective CY Q4 ’20 earnings calls. Importantly, Merck announced the retirement of CEO, Kenneth Frazier. Below, FENIX provides highlights and insights for the respective news items, including the observation that Januvia franchise US sales were -16% for FY 2020.

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.