Tag Archives: Saxenda

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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Evernorth Caps Wegovy and Zepbound Costs; Saxenda Pediatric CHMP Opinion

Two cardiometabolic-related news items have been observed: Evernorth Health Services announced a new pharmacy benefit capping the monthly OOP cost of Wegovy and Zepbound (view press release); and CHMP adopted a positive opinion for the Saxenda pediatric indication (view CHMP statement). Below, FENIX provides highlights and insights for the respective news items. 

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Skye Partners for Obesity Development; May CHMP Agenda; Altimmune Initiates Ph2 Study in AUD; Zealand Appoints New CDO; Cytokinetics Presents Additional Aficamten Analyses; Ionis Ph3 Olezarsen Topline Data

A series of cardiometabolic-related news items has been observed from Skye Bioscience, EMA, Altimmune, Zealand Pharma, Cytokinetics, and Ionis Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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November CHMP Agenda

The CHMP agenda (view here) for this month’s meeting (Nov 11-14) has been released and includes several cardiometabolic-related agenda items. Below, FENIX provides highlights and insights for the agenda.

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Novo and Eleven Therapeutics Collaborate for Nucleic Acid Therapeutics; July CHMP Agenda; Madrigal Completes Resmetirom NDA Submission; Capital Health Partners with Virta Health for Rx Reverse Launch

Four cardiometabolic-related news items have been observed: Eleven Therapeutics announced a collaboration with Novo Nordisk using Eleven’s DELiveri platform to identify molecules for nucleic acid delivery (view press release); the CHMP agenda (view here) for this month’s meeting (July 17-20) has been released; Madrigal announced it completed submission of the resmetirom NDA and requested a priority review (view press release); and Capital Health announced a partnership with Virta Health to launch Rx Reverse, a clinical program designed to help manage cost of treatment for diabetes and obesity (view press release). Below, FENIX provides highlights and insights on the respective news items.

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Novo’s GLP-1RA Drugs Under EMA Review; Novartis’s Entresto Patent Ruled Invalid; FDA Approves Expanded Indication for Leqvio; Tonix Initiates Ph2 Intranasal TNX-1900 Study for Pediatric Obesity

Four cardiometabolic-related news items have been observed: Novo Nordisk’s diabetes and obesity drugs, Ozempic/Wegovy (semaglutide) and Saxenda (liraglutide), are under EMA review following two cases of suicidal ideation and one case of self-harm from users in Iceland (view article); Novartis announced the U.S. District Court for the District of Delaware ruled the patent covering Entresto and combinations of sacubitril and valsartan is invalid (view press release); Novartis also announced FDA approved a label update for Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C, as an adjunct to diet and statin therapy for patients who have not had a CV event but are at an increased risk for heart disease (view press release); and Tonix Pharmaceuticals announced the first participant has been enrolled in its Ph2 POWER study of TNX-1900, an intranasal potentiated oxytocin, for the treatment of pediatric obesity (view press release; CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

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Novo Nordisk Q4 ’22 Earnings Update

Novo Nordisk hosted its Q4 ’22 earnings call (press release; slides) and provided updates across its business, including Wegovy/Ozempic supply, GLP-1RA market dynamics, new QW insulin icodec data, and more. Below, FENIX provides highlights and insights from the call.

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Novo Q2 ’21 Post-earnings Event

Novo Nordisk hosted its post-Q2 ’21 earnings event and provided further details on the obesity market and Wegovy launch. Below, FENIX provides an overview of the commentary from senior management beyond what was discussed during the Q2 ’21 earnings call as well as insights from the call.

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Novo’s Oral Sema Alzheimer’s Studies Posted on CT.gov; Saxenda Receives Positive CHMP Opinion

Two cardiometabolic-related news items have been observed: the CT.gov records for Novo’s oral semaglutide Ph3 Alzheimer’s disease trials have been posted and Novo Nordisk announced Saxenda received a positive CHMP opinion for the treatment of obesity in adolescents. Below, FENIX provides highlights and insights for the respective items.

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Novo Broadens Icodec Ph3 program; CSO to Retire; Novo Q4 and FY ’20 Earnings Update

Novo Nordisk hosted its Q4 and FY ’20 earnings calls and provided updates across its pipeline and commercial activities, including plans to conduct a broader Ph3 QW insulin program and additional insight into the Ph3 high-dose oral semaglutide trial. Importantly, Novo disclosed Mads Krogsgaard Thomsen is retiring as EVP and CSO in February 2021 and Novo stock is trading at a near all-time high (view NVO). Below, FENIX provides highlights and insights from the call.

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