Category Archives: Topics

Tandem Control-IQ Pivotal Trial Problem

Tandem Diabetes Care announced that it is using the Tandem Device Updater to “resolve a Control-IQ technology software anomaly identified during the ongoing DCLP3 phase of the International Diabetes Closed Loop (IDCL) clinical trial.” According to the press release, Tandem is in discussion with the IDCL study investigators to evaluate any impact on the clinical or regulatory strategy. Recall, Tandem had been planning to launch Control-IQ as early as Summer 2019. Below, FENIX provides insight on the potential impact to the initial Control-IQ regulatory approval as well as thoughts on how Tandem has already started to spin the news as a positive indicator.

This content is for Read Less members only.
Register

Already a member? Log in here

Thoughts on Biocon Form 483 Observations and Impact to Semglee US Launch

Biocon has reportedly received six Form 483 observations during FDA’s pre-approval inspection of its insulin drug substance manufacturing facility in Bengaluru (Bangalore); however, this Form 483 is not yet listed in FDA’s public database. Interestingly, the Biocon press release states the FDA inspection was “triggered by a New Drug Application submitted by our insulin API customer” which is assumed to be referencing the bs-glargine filing by Mylan. Below, FENIX provides insight on the impact to the Semglee (glargine U100) US commercial launch and thoughts on how a delayed tentative approval could potentially lead to a royalty agreement between Sanofi and Mylan.

This content is for Read Less members only.
Register

Already a member? Log in here

Former Medtronic CMO Joins Senseonics

Senseonics announced the appointment of Francine Kaufman as Chief Medical Officer (pictured below). Kaufman is a pediatric endocrinologist and most recently worked at Medtronic as the CMO and VP of Global Clinical, Regulatory, and Medical Affairs. Below, FENIX provides thoughts on how Kaufman immediately provides significant credibility to Senseonics during the critical Eversense implantable CGM launch phase.

This content is for Read Less members only.
Register

Already a member? Log in here

Pfizer Licenses T1DM Immunotherapy From AnTolRx

AnTolRx, a privately held biotech company, announced Pfizer has exercised its option to license AnTolRx’s antigen-specific immunotherapy for T1DM. According to the press release, AnTolRx will receive an up-front payment and is eligible for milestone and royalty payments. The specific financial terms were not disclosed. Below, FENIX provides thoughts on the AnTolRx opportunity in the context of other T1DM immunotherapies in development.

This content is for Read Less members only.
Register

Already a member? Log in here

New Glooko Business Model; Glooko Mobile App to be Given Away for Free

Glooko announced it is removing the subscription fee for its data management platform. Previously, users who did not have coverage through their insurance or employers were required to pay a fee to access the platform. Additionally, the Glooko/Senseonics data integration appears to be complete. Now, users can directly sync Eversense data to the Glooko platform via the Senseonics Cloud. Below, FENIX provides thoughts on Glooko’s new business model as well as insight into how the integration with Eversense likely benefits Senseonics more than Glooko.

This content is for Read Less members only.
Register

Already a member? Log in here

Thoughts on Lilly’s Humalog Authorized Generic

Today, Lilly announced it will commercialize an authorized generic for Humalog U-100 at a 50% discount to the current Humalog per-unit list price for vial and Kwikpen. Nothing was mentioned about Humalog premixes. Below, FENIX provides summary and insight, including Lilly’s potential motivation and why Novo Nordisk is unlikely to follow.

This content is for Read Less members only.
Register

Already a member? Log in here

Fiasp Pediatric Indication Filed in US and EU

Novo Nordisk announced it has submitted EMA and FDA applications for the use of Fiasp in adolescents and pediatrics based on results from the Onset 7 study (children down to age 1). According to the press release, Novo anticipates a response from EMA later in 2019 and an FDA decision in “early 2020.” Below, FENIX provides insight into the Fiasp pediatric filings as well as context from Lilly’s upcoming URLi pediatric study (Pronto-Peds).

This content is for Read Less members only.
Register

Already a member? Log in here

Sota/Dapa T1DM EU Regulatory Analysis; Sota Receives Positive CHMP Opinion

CHMP has adopted a positive opinion for the use of 200 and 400mg Zynquista (sotagliflozin) in T1DM. Recall, on January 31, CHMP adopted a positive opinion for the use of Forxiga in T1DM (previous FENIX insight). Of note, the proposed limitations for use of both Zynquista and Forxiga are identical. Below, FENIX provides insights from the Zynquista positive CHMP opinion and potential read-through to the upcoming Zynquista FDA action date.

This content is for Read Less members only.
Register

Already a member? Log in here

Xultophy Label Update at Parity with Soliqua

According to Drugs@FDA, Xultophy label was updated to expand the indication for use in patients uncontrolled on OADs. Additionally, the new label also included 3 other major changes: 1) recommended starting dose, 2) clinical data from DUAL I, DUAL IV trials and 3) a caution for audible clicks. Of note, Novo did not issue a press release on this FDA approval. Below, FENIX provides an analysis of the updated Xultophy label and its impact on the injectable market segment.

This content is for Read Less members only.
Register

Already a member? Log in here

Janssen Diabetes VP Moves to Vertex

As of February 2019, Janssen’s VP and Franchise Medical Leader for the metabolism business, Gary Meininger (pictured below), has left Janssen and is now the SVP and Head of Pipeline Development for Vertex Pharmaceuticals. Prior to his ~9 years at Janssen, Meininger spent 8 years at Merck as a director of Merck Research Laboratories. Below, FENIX provides brief thoughts on Meininger’s departure.

This content is for Read Less members only.
Register

Already a member? Log in here