Category Archives: Other

Lilly and Life for a Child Expand Partnership; ViaCyte Appoints Michael Yang as CEO

Two diabetes-related news items have been observed: Lilly and Life for a Child announced an expansion of their partnership to continue addressing inequity in accessing quality diabetes care for children and young adults around the world; and ViaCyte announced the appointment of Michael Yang as the company’s CEO and member of the Board of Directors. Below, FENIX provides highlights and insights for the respective news items.

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Abbott Q4 ’20 Earnings Update and US DTC; Apple and Samsung Watch CGM?; Dario Acquires Upright Technologies

A series of diabetes-related news items have been observed: Abbott hosted its Q4 and FY ’20 earnings call; Abbott recently published an article on its website titled “FreeStyle Libre 2 Puts NBA Legend Ray Allen at Ease;” the Apple Watch Series 7 and the Samsung Galaxy Watch4 are both reportedly going to feature glucose monitoring; and DarioHealth announced its acquisition of Upright Technologies, a digital musculoskeletal company. Below, FENIX provides highlights and insights for the respective news items.

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New Novartis CV Regulatory Comments; Novartis and J&J Q4 ’20 Earnings Updates

Novartis and J&J hosted their Q4 and FY ’20 earnings calls and provided updates to their respective cardiometabolic businesses. Of note, Novartis highlighted the upcoming Q1 ’21 PDUFA date for PARAGON-HF and discussed the inclisiran CRL issued in December 2020. Novartis anticipates responding to FDA’s CRL for inclisiran in Q2 or Q3 ’21. Additionally, J&J comments on its CV/Met portfolio were limited as a majority of the call was focused on the company’s COVID-19 vaccine development. Below, FENIX provides highlights and insights for the respective news items, including thoughts on what the Entresto HFpEF indication may cover.

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New Diabetes/COVID-19 Publication in JDST

The Diabetes Technology Society announced the publication of a report titled, “How to Best Protect People With Diabetes From the Impact of SARS-CoV-2: Report of the International COVID-19 and Diabetes Summit” in the Journal of Diabetes Science and Technology. The report is a summary of the Virtual International COVID-19 and Diabetes Summit, which was held on August 26-27, 2020, and included 79 speakers from NIH, CDC, ADA, HCPs, and manufacturers.

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Verquvo (Vericiguat) Approved by FDA; Label Analysis, Entresto and CYTK Implications

Merck and Bayer received FDA approval of vericiguat, branded as “Verquvo,” for symptomatic chronic HF (Merck press release here and Bayer press release here). Recall, vericiguat received Priority Review from FDA in July 2020 despite the modest 10% RRR in the VICTORIA CVOT primary endpoint (view NEJM publication). For context, Verquvo is the first treatment for chronic HF approved specifically for patients following a hHF or need for outpatient intravenous diuretics. Below, FENIX details its Verquvo label analysis, including the potential for counter-detail by SGLT2i manufacturers, as well as thoughts on the cumulative regulatory tailwinds for Cytokinetics’s omecamtiv.

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High-Dose Ozempic Filed with FDA; Andy Ajello Joins Vifor

Novo Nordisk announced it has filed the sNDA for high-dose Ozempic (2.0mg) based on results from the SUSTAIN FORTE trial, which read out in November 2020 (previous FENIX insight). Additionally, Andrew (Andy) Ajello, former Lexicon Commercial Lead and Novo SVP of US Diabetes/Obesity Sales, has joined Vifor Pharma as the VP of US sales (view LinkedIn profile). Below, FENIX provides thoughts and insights on the respective news items.

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Metacrine NASH Fast Track Designation; Senseonics Receives Positive Coverage Decision for EmblemHealth; Insulet Launches Omnipod DASH in Canada

A series of cardiometabolic-related news items have been observed: Metacrine announced FDA granted Fast Track designation to MET642 for the treatment of NASH; Senseonics announced a positive coverage decision for its implantable CGM from EmblemHealth; and yesterday, Insulet announced the Canadian launch of Omnipod DASH. Below, FENIX provides highlights and insights for the respective news items.

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JPM 2021 Day 4: Lexicon Poised for a Strong Comeback; Lexicon, Viatris, and Intercept @ JPM; Poxel/Metavant Partnership Terminated

On the final day of JPM 2021, FENIX has provided coverage of presentations by cardiometabolic companies including Lexicon, Viatris, and Intercept. Additionally, two separate cardiometabolic-related news items have been observed: Lexicon announced it received FDA feedback stating SOLOIST and SCORED results support a sotagliflozin NDA submission for a broad HF indication; and Poxel/Metavant announced the termination of their partnership. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage, including Lexicon’s proposed broad HF label for sotagliflozin and Viatris’s biosimilar Toujeo.

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JPM 2021 Day 3: Bayer, Esperion, Precision Bio, Hikma, Vifor; High-dose Oral Sema PIONEER PLUS Trial Posted on CT.gov; Dario Announces Two New Additions to Scientific Advisory Board

On day three of JPM 2021, FENIX has provided coverage of presentations from Bayer, Esperion, Precision Biosciences, Hikma, and Vifor. Additionally, two separate cardiometabolic-related news items have been observed: a CT.gov record has been observed for Novo Nordisk’s PIONEER PLUS trial investigating high-dose oral semaglutide in people with T2DM; and DarioHealth announced Marilyn Ritholz and David Horwitz will be joining the Scientific Advisory Board. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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JPM 2021 Day 2: LLY, NVO, ABT, PODD, AMRN, and IONS; Bayer’s Finerenone Receives Priority Review for DKD

On day two of JPM 2021, FENIX has provided coverage of presentations by Lilly, Novo Nordisk, Abbott, Insulet, Amarin, and Ionis. Additionally, one separate cardiometabolic-related news item has been observed: Bayer announced FDA granted priority review of finerenone for patients with DKD. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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