Category Archives: Basal Insulin

FDA Issues Final Rule on Definition of “biological product”; ATTD 2020 Key Press Releases (Feb 20)

On the second day of the ATTD 2020 conference, a series of diabetes-related press releases have been observed including Abbott Libre RWE, Tandem to file Control IQ for peds in March 2020, Roche’s new “InsulinStart” program, Companion Medical compatibility with Fiasp, and MannKind Afrezza PK and pulmonary function data. Separate from the conference, FDA announced that it has issued a final rule on the definition of a biological product ahead of the March 23, 2020 insulin reclassification from a drug to a biologic. 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 Q4 ’19 London Earnings; Sanofi and BD Q4 ’19 Earnings Updates

Novo Nordisk hosted its post-Q4 ’19 earnings event in London. Furthermore, Sanofi and Becton Dickinson held their respective Q4 ’19 earnings calls. Below, FENIX provides highlights and insights from the earnings calls including Sanofi’s plans to divest its interest in efpeglenatide as well as thoughts on how Novo’s QW basal insulin icodec could have broader implications to the hybrid closed-loop market.

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

Thoughts on New CVS Program to Eliminate Diabetes Drug OOP Costs

CVS Health recently announced a new program called “RxZERO,” which is said to completely eliminate all out of pocket costs (OOP) for diabetes prescription drugs. According to the press release, RxZERO will provide the benefit to members “without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.” Below, FENIX provides thoughts on the RxZERO program in the context of the ongoing drug pricing debate in the US.

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

Lilly and Roche Q4 ’19 Earnings Updates

Lilly and Roche hosted their respective Q4 and FY 2019 earnings calls and provided updates to their respective diabetes businesses. Of note, Lilly disclosed additional information regarding the impending initiation of the tirzepatide T2DM CVOT, and Roche indicated it plans to pursue smartphone pump control. Below, FENIX provides highlights and insights from the calls including thoughts on how Lilly’s tirzepatide CVOT trial design compares to the 2008 FDA Guidance.

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

Lilly to Donate Insulin Pens; Fractyl Launches Revita DMR in the UK

Two diabetes-related news items have been observed including an announcement from Lilly that the company is donating 200k insulin pens over 3 years and Fractyl is launching its Revita DMR device in the UK. 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

Oral Semaglutide and URLi CHMP Opinions Anticipated; Forxiga Lower-limb Warning?; Xeris Gvoke Filed (CHMP Agenda January 27-30)

The CHMP agenda for this month’s meeting (January 27-30) has been released, and it includes four notable items (oral semaglutide opinion, URLi opinion, potential Forxiga lower limb amputation warning, and Xeris’s Gvoke initial filing) as well as some other items. Below, FENIX provides diabetes-related highlights and insights from the January 2020 CHMP agenda.

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

Biocon/Mylan Bs-Glargine PDUFA in June 2020; Biocon CY Q4 ’19 (FY Q3 ’20) Earnings Update

Biocon hosted its CY Q4 ’19 (FY Q3 ’20) earnings call and provided updates to the ongoing bs-glargine US review including a more specific FDA approval and launch timeline. Additionally, Biocon discussed how recent legislation has aided the bs-glargine review given the impending March 23, 2020 insulin reclassification. Below, FENIX provides insight and context on the Biocon/Mylan bs-glargine product.

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

New i-SENS BT BGM 510(k) Clearance; Integrity Non-invasive Glucose Meter CE Mark; Livongo Available to Horizon BCBS NJ; Jay Skyler Joins Oramed Advisory Board

A series of diabetes-related news has been observed including the 510(k) clearance for a new i-SENS BGM (believed to have Bluetooth connectivity), Integrity Applications received CE Mark for its non-invasive glucose meter, Livongo is now available to Horizon BCBS NJ, and Oramed appointed Jay Skyler to its scientific advisory board. Below, FENIX provides highlights and insights related to the respective news items.

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

JPM 2020 Day 2: LLY, NVO, LVGO, SNY, PODD, ABT, and BD

On the second day of JPM 2020, FENIX has provided coverage of presentations by major diabetes manufacturers including Lilly, Novo Nordisk, Livongo, Sanofi, Insulet, Abbott, and BD. Additionally, Lilly issued a separate press release announcing the addition of Humalog Mix75/25 KwikPen and the Humalog Junior KwikPen to its insulin savings program. Further, Biocorp issued a press release noting a strengthening of the relationship with Sanofi for the Mallya connected pen solution. Below, FENIX provides a topline summary of key takeaways by company followed by more in-depth coverage.

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