Category Archives: Other

Kerendia Early Launch and HCP Website Analysis

Bayer has updated its Kerendia HCP website with new messaging for finerenone following FDA approval in July 2021. Recall, the Kerendia HCP website previously was active with simple “now approved” messaging and was bare aside from a link to the press release, webinar sign up, speak with a Kerendia representative, and the prescribing information. Of note, the patient website appears to be largely unchanged since the initial approval. Below, FENIX provides an analysis of the initial Kerendia HCP messaging and early Kerendia Rx data, including a time-aligned launch comparison with other key brands.

This content is for Read Less members only.
Register
Already a member? Log in here

New Non-invasive BGM; Amarin Updates Vascepa US Go-to-market Strategy; Welldoc Receives 510(k) Clearance for Bolus and Premixed Insulin Titration; CinFina Agreement with Janssen for QW Obesity Assets

A series of cardiometabolic-related news items have recently been observed: Know Labs announced the addition of KnowU, a portable Bio-RFID glucose monitoring device, to the company’s portfolio of non-invasive diagnostic technology; Amarin announced an update to its Vascepa go-to-market strategy, including US field force layoffs; Welldoc announced FDA 510(k) clearance for the BlueStar Insulin Adjustment Program for bolus and premixed insulin titration; and CinFina Pharma announced an agreement with Janssen Sciences Ireland Unlimited Company to acquire exclusive WW rights to four QW anorectic agents for the treatment fo obesity. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Kerendia Trial Initiated in Non-T2DM CKD Patients (FIND-CKD); New Virtual Diabetes Platform Launched

Two cardiometabolic-related news items have been observed: Bayer announced the initiation of FIND-CKD, a Ph3 study evaluating the use of Kerendia (finerenone) in patients with non-T2DM CKD, and 9am.health announced the launch of its virtual care platform for patients with prediabetes or T2DM in addition to raising $3.7M in seed funding to scale its operations. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Diamyd’s Ph3 T1DM Vaccine Placed on Partial Clinical Hold; Osama Hamdy Joins Nemaura Scientific Board; Medtronic Licenses Implantable Pump; Diabeloop joins the AACE Corporate Advisory Program and Appoints US Scientific Advisors

A series of cardiometabolic-related news items have been observed: Diamyd’s Ph3 has been placed on partial clinical hold (press release); Nemaura announced Osama Hamdy joined the company’s advisory board (press release); Medtronic licenses implantable insulin pump from the Alfred E. Mann Foundation (press release); Diabeloop joins the AACE Corporate Advisory Program and Appoints US Scientific Advisors (press release). Below, FENIX provides highlights and insights from the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo Nordisk Center for Genomic Mechanisms of Disease Launched; Lifescan and Welldoc Partnership; Xeris Approved to Acquire StrongBridge Pharma; Oramed Reaches 50% Enrollment in NASH

A series of cardiometabolic-related news items have been observed: the Novo Nordisk Foundation and the Broad Institute of MIT and Harvard announced the launch of the Novo Nordisk Foundation Center for Genomic Mechanisms of Disease; Lifescan and Welldoc announced a partnership to integrate Welldoc’s chronic condition platform into the OneTouch Solutions portal; Xeris announced it received stockholder approval for the previously announced proposed acquisition of Strongbridge Biopharma; and Oramed announced it has reached over 50% enrollment in the Ph2 trial evaluating its oral insulin (ORMD-0801) in T2DM patients with NASH. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

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.

This content is for Read Less members only.
Register
Already a member? Log in here

Another Inclisiran CVOT (VICTORION-2P); Not Even in Primary Prevention

A CT.gov record has been observed for another Ph3 inclisiran CVOT, called VICTORION-2 PREVENT (aka VICTORION-2P), in 15,000 adults 40 years of age and older with established ASCVD (view CT.gov record). Notably, the VICTORION-2P trial is evaluating inclisiran in secondary prevention, which is similar to ORION-4 (ongoing with primary completion in 2026; view CT.gov record). Below, FENIX provides additional trial details as well as thoughts on the trial design in comparison to ORION-4.

This content is for Read Less members only.
Register
Already a member? Log in here