Tag Archives: NA

Invokana Receives Positive CHMP Opinion for CV Indication

Janssen announced CHMP has granted a positive opinion to update the Invokana and Vokanamet labels to include data on the reduction of 3P-MACE in patients with T2DM and a history of CVD or at least 2 risk factors.

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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BD Patch Pump Update; CY Q2 ’18 Earnings (FY Q3 ’18)

Becton Dickinson hosted its CY Q2 ’18 Earnings (FY Q3 ’18) call and provided an update on the development of their T2DM patch pump, called Swatch. BD plans to file the device in both the US and EU later this year with an initial limited launch in late FY 2019 (CY Q3 ’19). Below, FENIX provides further details into the BD Swatch pump and insight into its impact to the T2DM market.

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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Dexcom Q2 ’18 Earnings Update

Dexcom hosted its Q2 ’18 earnings call and provided updates to its CGM marketing and pipeline activities. Of note, Terry Gregg, former CEO and Chairman of the Board, has retired. Kevin Sayer, Dexcom’s current CEO, will fill the position. Below are highlights 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.

Lilly’s New Diabetes Helpline to Aid Insulin Access

Lilly announced the availability of its new “Lilly Diabetes Solution Center helpline” to assist patients in finding appropriate programs to make insulin treatments more affordable. Below, FENIX provides insights about the new Lilly program in the context of patient need and other savings programs from large insulin manufacturers.

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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Sanofi Q2 ’18 Earnings Update; Pfizer Discontinues Ph1 T1DM Compound

Sanofi and Pfizer hosted their respective Q2 ’18 earnings calls. Sanofi only briefly discussed its diabetes business including continued headwinds for its glargine franchise. Of note, Sanofi has recently updated the name of its efpeglenatide CVOT to “AMPLITUDE-O.” Pfizer did not discuss its Steglatro (ertugliflozin) franchise; however, in the pipeline update, it was noted that PF-06342674 (IL-7 receptor precursor modulator) for the treatment of T1DM has been discontinued. Below are highlights from the respective calls.

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 Drops Lawsuit Over Generic Farxiga

According to court documents, AZ has dismissed its lawsuit against Zydus Pharmaceuticals over Zydus’ generic Farxiga filing in the US. The suit was initially filed with the US District Court, New Jersey on May 3, 2018 and claimed infringement on two AZ patents (6,414,126 and 6,515,117). Interestingly, the suit was dropped even though Zydus did not answer AZ’s complaint or filed a motion for summary judgment. It is unclear as to why AZ decided to withdraw its lawsuit vs. Zydus; however, AZ and Zydus may have come to an agreement outside of the courts. Below, FENIX provides an analysis based on the FDA Orange Book and Paragraph IV filings.

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.

New Ozempic Concentrations; Potential Autoinjector in Ph1 Study

A new Ph1 trial comparing different concentrations of semaglutide between FlexTouch, NovoPen4, and a novel injection device (DV3372) has appeared on CT.gov. In the 68-participant study, the current formulation of Ozempic (1.34mg/mL concentration delivered via FlexTouch, a.k.a. PDS290) will be compared to three more concentrated formulations of semaglutide (0.5mg/mL, 1.0mg/mL, and 2.0mg/mL). Below, FENIX analyzes the trial design, including insights regarding a potential Ozempic autoinjector and a reusable injection device, as well as the value of higher concentrations in reducing the amount of pens needed.

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.

Lexicon Q2 ’18 Earnings Update

Lexicon hosted its Q2 ’18 earnings call and provided updates on sotagliflozin. Discussion centered on the potential FDA adcom for sotagliflozin in T1DM, DKA consensus guidelines being developed by ATTD, and the benefit of sotagliflozin in reducing hypoglycemia.

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.

Tandem Q2 ’18 Earnings Update

Tandem hosted its Q2 ’18 earnings call and provided updates to its insulin pump business including its closed-loop R&D programs. Tandem has scheduled an institutional investor day for September 25, 2018 where it will provide further updates on its pipeline and international 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.

Biocon/Mylan Glargine CRL; Biocon and Merck Q2 ’18 Earnings

Biocon hosted its CY Q2 ’19 (FY Q1 ’19) earnings call and provided an update on its biosimilar glargine development program including the CRL that was issued in early June 2018. Additionally, Merck hosted its Q2 ’18 earnings call and briefly touched on its diabetes business unit. Below, FENIX provides an overview of the calls and insight on Biocon’s glargine CRL.

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.