Tag Archives: EMA

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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Pfizer Hosts 2022 R&D Day; Novo Initiates 7.2mg Sema Ph3 Obesity Trial; ADA 2023 Diabetes SoC Guidelines; December CHMP Agenda

A series of cardiometabolic-related news items have been observed: Pfizer hosted a Near-Term Launches and High-Value Pipeline investor event and discussed its two oral GLP-1RAs, PF-07081532 and danuglipron (slides; webcast); Novo Nordisk initiated a Ph3 semaglutide obesity trial evaluating up to a 7.2mg QW subcutaneous dose (STEP UP; view CT.gov record); ADA announced it published the 2023 SoC guidelines in Diabetes Care (view press release; view publication); and the CHMP agenda (view here) for this month’s meeting (December 12-15) has been released. Below, FENIX provides insight on the respective news items, including the impact of the updated ADA Standards of Care guidelines.

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Abbott Q3 ’22 Earnings Update; EMA Expects Ozempic Supply Shortage Into 2023

Two cardiometabolic-related news items have been observed: Abbott hosted its Q3 ’22 earnings call (press release; view infographic) and provided updates on its Libre business; and EMA updated its shortages catalog to include Ozempic (view update here). Below, FENIX provides highlights and insights for the respective new items, including insight into how recent Ozempic publicity may be exacerbating the semaglutide shortage.

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