Tag Archives: Lilly

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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EASD 2024 Key Press Releases (Sep 09)

On the first day of EASD 2024, six key news items were observed from Terns Pharmaceuticals, Zealand Pharma, Diamyd Medical, Cytokinetics, Lilly/Superluminal Medical, and Akero Therapeutics. The following topics are covered below (hyperlinks to external items):

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Lilly QW Insulin QWINT-1 and -3 Topline Results; Lilly Initiates Ph3 Orforglipron Maintenance Study; Lilly-Backed OrsoBio Raises $67M in Series B for Obesity Development

Three cardiometabolic-related news items have been observed: Lilly announced positive topline results from its Ph3 QW insulin efsitora alfa trials, QWINT-1 and QWINT-3 (view press release); Lilly initiated a Ph3 study (ATTAIN-MAINTAIN; view CT.gov record) evaluating QD orforglipron in adults with overweight or obesity with weight-related comorbidities who have completed SURMOUNT-5 (tirzepatide vs. semaglutide); and OrsoBio raised $67M in a Series B financing round for the development of its mitochondrial protonophores for obesity (view article). Below FENIX, provides highlights and insights for the respective news items.

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Abbott Partners with Beta Bionics; Dexcom at Wells Fargo; Lilly Partners for Drug Discovery; AZ Initiates Oral GLP-1RA Ph2b Trial in T2DM; BioAge Files for IPO; Bayer, Arrowhead, and Lexicon Data at ESC 2024; Esperion Secures Additional Nexletol/Nexlizet Coverage; Skye Appoints New CMO; Scholar Rock Appoints New CBO

A series of cardiometabolic-related news items have been observed from Beta Bionics/Abbott, Dexcom, Lilly/HAYA, AstraZeneca, BioAge Labs, Bayer, Arrowhead Pharmaceuticals, Lexicon Pharmaceuticals, Esperion Therapeutics, Skye Biosciences, and Scholar Rock. Below, FENIX provides highlights and insights for the respective news items.

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