Category Archives: Topics

BI Receives BTD for Survodutide and Initiates 2 Ph3 MASH Trials; Roche Ph2 CT-388 Trial in Obesity+T2DM; Drug Compounder Group Sues FDA; WeightWatchers to Offer Compounded Semaglutide; Novo Invests $158M in Insulin Plant

A series of cardiometabolic-related news items have been observed from Boehringer Ingelheim, Roche, the Outsourcing Facilities Association, WeightWatchers, and Novo Nordisk. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

AZ Lp(a) Licensing Deal; Novo Reaches Semaglutide Patent Settlement with Viatris; Trinity Completes Pre-Pivotal CGM Trial

Three cardiometabolic-related news items have been observed: AstraZeneca announced a licensing deal with CSPC Pharmaceutical Group for a preclinical oral Lp(a) disruptor (view press release); Novo Nordisk and Viatris have settled a lawsuit over one of Novo’s semaglutide patents (view article); and Trinity Biotech announced the completion of its EU pre-pivotal CGM trial (view press release). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Elevai Files Patents For Obesity Lean Mass Preservation; Medtronic Pump Recall

Two cardiometabolic-related news items have been observed: Elevai Biosciences announced it filed two patent applications for EL-22 (oral myostatin engineered probiotic) as a monotherapy or combination with GLP-1RAs (view press release); and Medtronic announced a voluntary recall of its MiniMed 600/700 series insulin pumps due to shortened battery life issues (view press release). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

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.

This content is for Read Less members only.
Register
Already a member? Log in here

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.

This content is for Read Less members only.
Register
Already a member? Log in here

Metsera Partners with Amneal for Obesity Manufacturing; Rivus Obesity Data at HFSA 2024; Sagimet Receives BTD for Denifanstat; Biomea Establishes Scientific Advisory Board; Madrigal Appoints New SVP

A series of cardiometabolic-related news items have been observed from Metsera/Amneal Pharmaceuticals, Rivus Pharmaceuticals, Sagimet Biosciences, Biomea Fusion, and Madrigal Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

FDA Lifts BMF-219 Clinical Hold; Abvance ABV 101 Virtual KOL Event

Two cardiometabolic-related news items have been observed: FDA lifted the clinical hold on Biomea Fusion’s clinical trials of BMF-219 in T2DM and T1DM (view press release; view webcast); and Abvance Therapeutics hosted a virtual KOL event for its ABV 101 asset (view webcast). Below, FENIX provides highlights and insights for the respective news items. 

This content is for Read Less members only.
Register
Already a member? Log in here

Novo and Evotec Partner for Cell Therapy Development; J&J Divests CVRM Portfolio

Two cardiometabolic-related news items have been observed: Evotec and Novo Nordisk entered into another cell therapy development partnership (view press release); and Johnson & Johnson is divesting its CV and metabolic drug business unit (view article). Below, FENIX provides highlights and insights into the Evotec/Novo partnership and the J&J divestment.

This content is for Read Less members only.
Register
Already a member? Log in here

Galmed MASH Open-Label Publication; Entera/OPKO GLP-1/GCG Pre-Clinical Update

Two cardiometabolic-related news items have been observed: Galmed published one-year open-label results from its Ph3 MASH study (view press release; view publication); and Entera Bio and OPKO Health provided updates on its preclinical oxyntomodulin asset in obesity (view press release). Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here