Category Archives: GLP-1RA

Ionis Initiates New Ph3 Study in Hypertriglyceridemia; Real-World Evidence Study of PDT BT-001 for T2DM; Metacrine Announces MET409 Topline Results; Esperion and Pfizer Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Ionis announced the initiation of a second Ph3 clinical study (CORE) evaluating olezarsen in patients with severe hypertriglyceridemia; Better Therapeutics and Mass General Brigham announced a partnership for real-world evidence study evaluating the long-term effectiveness of Better Therapeutics’s BT-001; Metacrine announced topline results from the MET409 + empagliflozin Ph2a trial in patients with T2DM and NASH; and Esperion (press release; slides) and Pfizer (press release; slides) hosted their respective Q3 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items.

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Novo Raises 2021 Guidance; Novo’s “Bigger Than Me” Anti-Obesity Awareness Campaign; Biocon’s Form 483 Observations Revealed; Novel Human Neo-Islet Technology Published

Four cardiometabolic-related news items have been observed: Novo Nordisk announced it has raised its 2021 guidance ahead of the Q3 ’21 earnings release on November 3; Novo has initiated an unbranded “Bigger Than Me” campaign for anti-obesity awareness featuring Queen Latifah (view article); It has been reported that details from the Form 483 observations made in FDA’s September 2021 pre-approval inspection of Biocon’s Malaysian facility were released to the public (view article); and SymbioCellTech announced pre-clinical data for its Neo-Islets technology have been published in PLOS ONE. Below, FENIX provides highlights and insights for the respective news items.

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Sinocare and EoFlow Diabetes Tech Collaboration; Provention Announces Positive Interim Results for Ph1 PROVENT Trial; Dario Partners with Virgin Pulse; Teva and Adocia Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Sinocare announced it intends to invest $7.9M in EOFlow to combine Sinocare’s sensors with EOFlow pumps in China; Provention Bio announced positive interim results for its PRV-101 vaccine trial (PROVENT); Dario announced a partnership with Virgin Pulse; Teva (press release; slides) hosted its Q3 ’21 earnings call; and Adocia issued a press release for its Q3 ’21 earnings. Below, FENIX provides highlights and insights for the respective news items.

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Lilly’s Ph3 Tirzepatide SURPASS-4 Results Published in Lancet; FDA Pre-Submission for rt-Glucose Salivary Test; Ultrahuman Hires Chief Business Officer; J&J Q3 ‘21 Earnings Update

A series of cardiometabolic-related news items have been observed: Lilly announced results of its Ph3 SURPASS-4 trial comparing tirzepatide to insulin glargine in patients with T2DM and an increased CV risk were published in The Lancet (view publication); IQ Group Global announced that GBS Inc has filed a pre-submission package with FDA for its salivary glucose test; Ultrahuman announced Bhuvan Srinivasan will join the company as its first chief business officer; and J&J hosted its Q3 ’21 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items.

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Jardiance HFpEF Indication Filed in EU; Generic Sitagliptin (EMEA/H/C/005741) CHMP Decision?; October 11-14 CHMP Agenda

The CHMP agenda for this month (October 11-14) has been released, and it includes two notable items, BI/Lilly has filed the Jardiance HFpEF indication and an opinion for generic sitagliptin (EMEA/H/C/005741) is up for adoption. Below, FENIX provides highlights and insights from the October 2021 CHMP agenda.

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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.

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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.

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Oral Sema Ph3 Obesity Program Initiated; GlucoModicum Appoints Former Dexcom Exec; Lilly Contributes to T1DM Camp Initiative

A series of cardiometabolic-related news items have recently been observed: a Novo Nordisk trial evaluating oral semaglutide in adults with obesity, called OASIS 1, has been observed on CT.gov; GlucoModicum announced the appointment of Peter Gerhardsson to Senior Advisor; and Lilly announced a commitment of nearly $1M donation over the next three years, in conjunction with the Helmsley Charitable Trust, to support a T1DM Camp Initiative. Below, FENIX provides highlights and insights for the respective news items.

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Ph3 Icosema Trial Observed; Novel T1DM Treatment Development; DIAGNODE-3 Trial Observed

Three cardiometabolic-related news items have recently been observed: Novo Nordisk initiated the first Ph3 icosema trial (COMBINE 3) evaluating icosema (QW insulin icodec + semaglutide) vs. basal-bolus in T2DM patients; Adhera Therapeutics announced an agreement with Melior Pharma for Adhera to license MLR-1023 (tolimidone) for the development of a novel T1DM therapeutic option; and Diamyd initiated a Ph3 trial (DIAGNODE-3) evaluating the Diamyd diabetes vaccine in recently diagnosed T1DM patients carrying the HLA DR3-DQ2 haplotype. Below, FENIX provides highlights and insights for the respective news items.

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