Novo hosted its 2022 Capital Markets Day (presentations) and provided updates on the strategic direction of the company across key commercial and R&D activities. Below, FENIX provides details and insights from the call.
A series of cardiometabolic-related news items have been observed: Lexicon announced it has withdrawn the sotagliflozin HF NDA; Lexicon hosted its Q4 and FY ’21 earnings call (press release); Biocon/Viatris announced Biocon will acquire the Viatris Biosimilars business; Viatris hosted an investor day and disclosed it has filed a generic Ozempic (press release; slides). Below, FENIX provides highlights and insights for the respective new items.
A series of cardiometabolic-related news items have been observed: Lilly initiated a Ph2 study evaluating LY3561774 (ANGPTL3 from Dicerna) despite the Novo Nordisk acquisition of Dicerna (view CT.gov record); and Ionis (press release; slides) and MannKind (press release) hosted their respective earnings calls. Below, FENIX provides highlights and insights for the respective new items.
A series of cardiometabolic-related news items have been observed: Insulet hosted its FY ’21 earnings call (press release); Vonage recently announced Novo Nordisk has chosen Vonage Contact Center (VCC) to support Novo’s international operations customer engagement; Esperion (press release; slides) and Teladoc (press release; slides) hosted their respective Q4 ‘21 earnings calls; and Adocia published its Q4 ’21 and FY ‘21 earnings. Below, FENIX provides highlights and insights for the respective new items.
A series of cardiometabolic-related news items have recently been observed from Provention Bio, Medtronic, Tandem, Lilly, RosVivo Therapeutics, and the CHMP. Below, FENIX provides highlights and insights for the respective new items.
Tandem announced FDA has cleared its remote bolus insulin dosing feature for its t:connect mobile app. The updated t:connect mobile app provides t:slim X2 insulin pump users the ability to program/cancel bolus insulin requests through their compatible iOS or Android smartphone. Below, FENIX provides brief thoughts on what the launch of the remote bolus feature means for Tandem, Insulet, and Medtronic.
A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q4 ’21 earnings event (see previous FENIX insight on Q4 ’21 Novo earnings from February 2); and Sanofi (press release; slides; view infographic) and Regeneron (press release; slides), hosted their respective Q4 and FY ’21 earnings calls. Below, FENIX provides highlights and insights for the respective new items.
A series of cardiometabolic-related news items have been observed: Lannett (press release), Merck (press release; slides), Roche (press release; slides), and BD (press release; slides) hosted their respective Q4 ’21 earnings calls. Below, FENIX provides highlights and insights for the respective new items.
Novo Nordisk hosted its Q4 and FY ’21 earnings call (press release; slides) and provided updates across its commercial and pipeline activities, including the ongoing Wegovy supply shortage and a Rybelsus launch update. Of note, Novo disclosed it has been notified of four Paragraph IV ANDA filings for generic Ozempic. Additionally, Novo reminded about its upcoming 2022 Capital Markets Day on March 3, 2022. Below, FENIX provides highlights and insights from the call.
The CHMP agenda for this month’s meeting (January 24-27) has been released, and it includes one notable item, a potential CHMP opinion for Jardiance HFpEF indication extension, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the January 2022 CHMP agenda.