Tag Archives: Lilly

FDA Tirzepatide Shortage Removal Update; Catalent Sells Site to Ardena; LifeVantage Launches MindBody GLP-1 System; Inventiva Receives Additional Funding for MASH; October CHMP Agenda; Sagimet Publishes FASCINATE-2 Data; Q Bio Appoints Jeff Brewer as CEO

A series of cardiometabolic-related news items have been observed from FDA, Catalent/Ardena, LifeVantage Corporation, Inventiva, EMEA, Sagimet Biosciences, and Q Bio. Below, FENIX provides highlights and insights for the respective news items.

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Senator Warren Calls for Novo/Catalent Block; Lilly Sends Cease-And-Desist to Compounding Pharmacies; Lilly and KeyBioscience Continue Obesity Collaboration

Three cardiometabolic-related news items have been observed: Senator Warren sent a letter to FTC to block Novo’s Catalent acquisition (view letter); Lilly sent cease-and-desist letters to compounding pharmacies to stop the sale and manufacture of non-branded tirzepatide (view article); and Lilly and KeyBioscience announced the extension of their DACRA development collaboration in obesity (view press release). Below, FENIX provides highlights and insights for the respective news items.

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FDA Removes Tirzepatide from Shortage List

FDA announced the tirzepatide shortage has been resolved and provided clarifications for compounding manufacturers. According to the announcement, FDA confirmed with Lilly that their stated product availability and manufacturing capacity can meet the present and projected national demand. However, patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from Lilly and distributors to local pharmacies. Below, FENIX provides brief insight into the impact of the FDA announcement.

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Eversense 365 Launched in US; Kailera Launches as Obesity Biotech; Lilly Funds New $4.5B Indiana Facility

Three cardiometabolic-related news items have been observed: Ascensia Diabetes Care announced the launch of the Eversense 365 CGM in the US (view press release); Kailera Therapeutics announced its launch as a biotech with an asset in Ph3 development for the treatment of obesity (view press release; view article); and Lilly announced a $4.5B investment to create a new R&D and manufacturing facility in Lebanon, Indiana (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Novo CB1 Ph2a Obesity Topline Results; Two Ph3 Tirzepatide Combo Psoriatic Studies Observed; Aligos Ph2a MASH Topline Results; AZ Initiates Ph2 LA Amylin Obesity Study; FTC Sues PBMs; Synjardy Receives Pediatric CHMP Positive Opinion

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Lilly, Aligos Therapeutics, AstraZeneca, FTC, and CHMP. Below, FENIX provides highlights and insights for the respective news items.

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Novo Enters Partnership with NanoVation for Cardiometabolic and Rare Diseases; Lilly and Axcelead Enter Development Partnership

Two cardiometabolic-related news items have been observed: NanoVation Therapeutics announced it entered into a multi-year partnership with Novo Nordisk for cardiometabolic and rare disease development (view press release); and Axcelead Drug Discovery Partners announced it entered into a development partnership with Lilly for multiple drug discovery programs (view press release). Below, FENIX provides highlights and insights for the respective news items.

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EASD 2024 Key Press Releases (Sep 12)

On the fourth day of EASD 2024, three key new items were observed from Noom, Lilly, and Sernova. The following topics are covered below (hyperlinks to external items):

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EASD 2024 Key Press Releases (Sep 10)

On the second day of EASD 2024, 8 key news items were observed from Lilly, Novo Nordisk, Abvance Therapeutics, Scholar Rock, Altimmune, Arrowhead Pharmaceuticals, Bayer, and Lexicon. The following topics are covered below (hyperlinks to external items):

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