Category Archives: Other

New ADA/EASD 2022 T2DM Guidelines; EASD 2022 Key Press Releases (Sept 23)

On the final day of EASD 2022, two key news items were observed: ADA/EASD presented the updated T2DM consensus guidelines (journal publication; download slides), placing obesity management as a key consideration; and Ionis announced AstraZeneca decided not to advance their PCSK9i (ION449; AZD8233) despite achieving positive Ph2b results (press release). Below FENIX provides insights and context from the respective announcements.

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Novartis Hosts Meet the Management Investor Event

Novartis hosted its 2022 Meet the Management event where the company provided details regarding its new focused strategy, the Sandoz spin-off, and R&D priorities (press release; view slides). Of note, the event was primarily comprised of multiple Q&A sessions. Below, FENIX provides highlights and insights from the event relating to Novartis’s CVRM business.

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EASD 2022 Key Press Releases (Sept 22)

On the fourth day of EASD 2022, three key news items were observed from Novo Nordisk, Merck, and Better Therapeutics. Separately, it has been observed that the start date has been delayed for Novo’s first cagrisema Ph3 pivotal trial (Ph3 REDEFINE-2). Below FENIX provides insights and context for the respective announcements.

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Biocorp’s SoloSmart receives CE Mark; EASD 2022 Key Press Releases (Sept 19)

On the first day of EASD 2022, Biocorp announced it received CE Mark for SoloSmart, an accessory medical device for Sanofi’s SoloStar/DoubleStar pens that records dose information (e.g., dose amount, time, and date). According to the press release, Biocorp will provide more details regarding the SoloSmart launch during its CY Q3 ’22 earnings call scheduled for September 29th. Below, FENIX provides brief thoughts on the new SoloSmart device as well as potential implications for Novo Nordisk, Lilly, and other insulin pen manufacturers.

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Alnylam and Regeneron to Advance NASH ALN-HSD Asset

Alnylam and Regeneron announced initial Part B data from the ALN-HSD Ph1 NASH study (view CT.gov record) and disclosed plans to initiate Ph2 development in late 2022. Recall, during its November 2021 R&D webinar, Alnylam highlighted 14-week HSD17B13 knockdown results from Part A of the ALN-HSD Ph1 study (previous FENIX insight). Below, FENIX provides context and insight on the latest ALN-HSD data readout.

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Akero Becomes a Frontrunner in NASH; Lilly Initiates Tirzepatide Ph2 TREASURE-CKD Trial; Oramed’s Oral Insulin Ph2 NASH Topline Results

Three cardiometabolic-related news items have been observed: Akero announced positive topline results from its Ph2b HARMONY trial evaluating QW efruxifermin (EFX) in pre-cirrhotic NASH (view CT.gov record); Lilly’s Ph2 tirzepatide CKD trial (TREASURE-CKD) has been observed (view CT.gov record); and Oramed announced positive topline results from its Ph2 trial evaluating ORMD-0801 in T2DM and NASH. Below, FENIX provides highlights and insights from the respective news items.

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Novo Partners with Microsoft for Drug Development; Novo Launches Unbranded Degludec; AZ Partners with Gatehouse Bio for HFpEF RNAi Therapeutic Development; September 2022 CHMP Agenda

Four cardiometabolic-related news items have been observed: Novo announced a partnership with Microsoft for drug development (view press release); Novo announced plans to launch an unbranded version of Tresiba (view press release); AZ partners with Gatehouse for HFpEF RNA-based drug development (view press release); the CHMP agenda for this month’s meeting (September 12-15) has been released and includes multiple cardiometabolic-related agenda items. Below, FENIX provides context and insight on the respective news items.

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Novo Licenses Zealand’s Zegalogue; Adocia Announces Preclinical PoC Data for its Islet Transplant; First Patient Dosed in G&L’s QW Insulin Ph1 Trial

Three cardiometabolic-related news items have been observed: Zealand announced the licensing of Zegalogue (dasiglucagon) to Novo; Adocia announced the first preclinical PoC data for AdoShell Islets in T1DM; and Gan & Lee announced the first patient has been dosed in its QW insulin (GZR4) Ph1 trial. Below, FENIX provides context and insight on the respective news items.

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Daprodustat FDA Adcom Scheduled for October 26, 2022

FDA has requested an advisory committee on October 26, 2022, to discuss the use of GSK’s daprodustat for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults (view FDA document here). Recall, in April 2022, FDA accepted the daprodustat NDA and set a PDUFA date for February 1, 2023, suggesting a standard review of 12 months total for an NME (previous FENIX insight). The NDA was based on positive results from five Ph3 studies in the ASCEND program which were reported in July 2021 (previous FENIX insight). Below, FENIX provides brief thoughts on the dapro adcom in the context of roxadustat and vadadustat.

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