Tag Archives: Novo Nordisk

Novo Initiates Ph1 Oral ASCL5 Inhibitor Study for Obesity; FDA to Host Public Feedback Meeting on CNPV; March CHMP Agenda

Three cardiometabolic-related news items have been observed: Lexicon Pharmaceuticals and Novo Nordisk initiated a Ph1 obesity study of its oral ASCL5 inhibitor (view press release); FDA shared plans to host a public feedback meeting regarding the CNPV pilot program (view press release); and the CHMP agenda for this month’s meeting (March 23-26) has been released (view agenda). Below, FENIX provides highlights and insights for the respective news items.

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Novo Initiates Ph3 Zenagamtide Obesity and Knee OA Study; Biohaven Completes Enrollment in its Ph2b Obesity Study

Two cardiometabolic-related news items have been observed: Novo Nordisk has initiated its Ph3 AMAZE 5 study of zenagamtide in knee OA (view CT.gov record); and Biohaven announced it completed enrollment for its Ph2b POC study evaluating QW and QM formulations of taldefgrobep alfa (view press release). Below, FENIX provides highlights and insights on the respective news items, including thoughts on Novo’s decision not to conduct AMAZE 5 H2H vs. tirzepatide.

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Retatrutide T2DM Data Continue to Impress; FDA Approves Novo’s High Dose Sema

Two cardiometabolic-related news items have been observed: Lilly shared positive topline data from its Ph3 TRANSCEND-T2D-1 study of retatrutide (view press release), and Novo Nordisk received FDA approval for its 7.2mg Wegovy (view press release). Below, FENIX provides highlights and insights on the respective news items, including a safety/efficacy analysis of how the TRANSCEND results position retatrutide relative to tirzepatide and cagrisema.

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Kailera Initiates Another Ph2 Ribupatide Study; Ascletis Reports Topline Ph2 Data; Laekna Announces Topline Ph1 Data; Glooko Connects with Roche’s CGM; SK pharmteco to Manufacture Long-Acting API for Current Lilly Product; Novo Acknowledges FDA Form 483

A series of cardiometabolic-related news items has been observed from Kailera, Ascletis Pharma, Laekna, Glooko, SK pharmteco, and Novo Nordisk. Below, FENIX provides highlights and insights into the respective news items.

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Novo and Hims Take Another Turn at a Partnership; AbbVie Reports Topline Ph1 Amylin Data; Regeneron & Hansoh Share Ph3 Olatorepatide China Results; Lilly Releases Statement on CMS Obesity BALANCE Model; Zepbound KwikPen Available on Amazon; Veru Enrolls First Patient in Ph2b PLATEAU Study; Sequel Expands AID Launch 

A series of cardiometabolic-related news items has been observed from Novo Nordisk/Hims & Hers, AbbVie, Regeneron Pharmaceuticals/Hansoh, Lilly, Amazon, Veru, and Sequel Med Tech. Below, FENIX provides highlights and insights into the respective news items.

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MiniMed Shares IPO Pricing; NMPA Approves Sciwind/Pfizer’s Ecnoglutide Injection in Obesity; Novo Appoints New SVP

Three cardiometabolic-related news items have been observed: MiniMed released its IPO pricing and began trading shares on the Nasdaq Global Select Market (view press release); Sciwind/Pfizer received approval for ecnoglutide in China (view press release); and Novo appointed Yan Cai as the new SVP and President of Greater China (view article; view LinkedIn post). Below, FENIX provides highlights and insights on the respective news items.

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FDA Issues Warning Letters for Misleading Pharmaceutical Advertising; Veru Initiates Enobosarm Ph2b PLATEAU Study; Vanda Initiates Tradipitant Ph3 Study

Three cardiometabolic-related news items have been observed: FDA issued warning letters for illegal marketing of compounded GLP-1RAs (view press release; view letters) and warned Novo over Ozempic ad (view article; view letter); Veru initiated the Ph2b PLATEAU study of enobosarm (selective androgen receptor modulator) for obesity (view CT.gov record); and Vanda Pharmaceuticals initiated the Ph3 tradipitant trial for the treatment of nausea and vomiting induced by GLP-1RA use (view CT.gov record).

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FDA Approves Biocon’s Generic Saxenda; Novo Partners for Oral Peptide Development; Medtronic Launches MiniMed Go in EU; Bloom Doses First Patient in Ph1 Obesity Trial; BreezeBio Raises $60M in Series B; Verdiva Completes Ph2b Obesity Enrollment; MHRA Raids Illegal Manufacturing Facilities in UK

A series of cardiometabolic-related news items has been observed from Biocon, Novo Nordisk, Medtronic, Bloom Science, Verdiva Bio, and MHRA. Below, FENIX provides highlights and insights for the respective news items.

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