Tag Archives: NA

Novo Partners for Early Stage Small Molecule Development

Novo Nordisk has formed a strategic alliance with Evotec for the discovery and development of novel small molecule compounds for the treatment of diabetes, obesity, NASH, CVD, and diabetic kidney disease. The partnership with Evotec is Novo’s 5th external R&D collaboration since the start of 2018. Financial terms of the agreement were not disclosed. Below, FENIX provides insight into Novo’s ongoing efforts to build up its early stage pipeline in adjacent therapy areas to diabetes via external partnerships.

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Oral semaglutide shows superiority in renal impairment patients (PIONEER 5)

Novo announced positive top-line results from PIONEER 5 demonstrating superiority in A1C and weight loss at 26-weeks for 14mg oral semaglutide vs. placebo in T2DM patients with moderate renal impairment. Below is a table representing all of the PIONEER data released thus far for oral semaglutide including PIONEER 1, 2, 3, 4, 5 and 7. FENIX also provides insights on the oral semaglutide development program, SGLT2i eGFR comparison, and a new Ph1 oral sema tablet bioequivalence study.

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Novo acquires Ziylo for glucose responsive insulin development

Novo announced (press release) the acquisition of Ziylo, a small incubator company based out of the University of Bristol developing synthetic glucose binding molecules. The purchase of Ziylo aligns with Novo’s strategic goal of developing glucose responsive insulin.

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Zealand Q2 ’18 earnings summary

Zealand hosted its Q2 ’18 earnings call (press release) and provided updates on its diabetes portfolio including dasiglucagon, which is being studied for three distinct indications (hypoglycemia rescue, use in a dual-hormone pump, and congenital hyperinsulinism).

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Xeris Q2 ’18 10-Q Filing Highlights

Xeris Pharmaceuticals filed its first 10-Q statement since its IPO in June 2018. In the 10-Q, Xeris confirmed filing of its Glucagon Rescue Pen in Q3 ‘18 via the 505(b)(2) pathway. Yesterday, Xeris released its Q2 ’18 earnings but did not have an associated earnings webcast.

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Xeris Glucagon Filed; Q2 ’18 Earnings

Xeris Pharmaceuticals released its Q2 ’18 earnings and disclosed the NDA submission for its Glucagon Rescue Pen. While Xeris did not specify the filing date, it is assumed to have occurred in July or August in accordance with timing from the company’s S-1 document.

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Medtronic Launches 670G & Guardian Connect Gamification App

Medtronic announced the launch of its “Inner Circle” patient engagement program for patients on either the 670G hybrid closed-loop or the standalone Guardian Connect CGM. Recall, Medtronic initially disclosed its plans for Inner Circle during the June 2018 Investor Day.

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