Metabolic Disorders

Cagrisema Leads The Charge For 2025

 

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

Evidence Growing For GLP-1s To Treat Alzheimer’s And Parkinson’s

 

GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results

Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

 
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Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

Arrowhead Moving Into Commercial Territory

 
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Christopher Anzalone is spearheading Arrowhead Pharmaceuticals' transformation from a development-focused to a commercial-stage biotech. The CEO touts an “almost plug and play” platform, a derisked development strategy and a busy pipeline with vast potential.

Quick Listen: Scrip's Five Must-Know Things

 
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In this week's podcast edition of Five Must-Know Things: CMS’s price reveal better than expected?; new diabetes risk data for Zepbound; can J&J’s lung cancer combo stand up to Tagrisso?; new recruits for BioMarin leadership; and Glenmark’s shifting revenues.

Intarcia’s Exenatide Implant Rejected Again As US FDA Denies Comparative Safety Argument

 
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Principal deputy commissioner Bumpus agrees with advisory committee findings that safety issues with ITCA 650 preclude approval, regardless of comparisons to other diabetes treatments. Final order caps a nearly eight-year regulatory saga that has grown increasingly rancorous.

New Analysis Finds Suicidal Thoughts Signal With Semaglutide

 

Database review contradicts earlier findings with Novo Nordisk’s blockbuster incretin, but its small size and flawed design mean its commercial implications will be limited.    

Lilly Data Show Zepbound Reduces Type 2 Diabetes Risk Long Term

 
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An extension of the pivotal study backing Zepbound (tirzepatide)’s approval for obesity demonstrated 94% risk reduction for type 2 diabetes as well as sustained weight loss over three years.

Stock Watch: Some Turbulence As Novo And Lilly Report Results

 
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Novo disappointed on high expectations with its second-quarter announcement resulting in stock price weakness. But after Lilly reported without disappointment, something unexpected happened.

2025’s Therapy Area Growth Drivers And Brakes: Part One – The Top Three By Revenues

 

Revenues from Rx and OTC pharmaceuticals are returning to the normal annual growth patterns seen during the past decade – the COVID-affected years excepted. In a 3-part series, In Vivo analyzes the market dynamics that support this trend, giving forecasts for individual therapy areas for 2025. This article focuses on the top three therapy areas by growth.

Quick Listen: Scrip's Five Must-Know Things

 
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In this week's podcast edition of Five Must-Know Things: Merck & Co. steps into CD19 bispecific space; gene therapy patients rise, but slowly; Madrigal’s Rezdiffra plans; Korean biopharma financing recovering?; and approvals to watch out for in Q3.

Rivus Gets A Muscle-Sparing Heart Failure Hit

 

But competing with the likes of Wegovy and Zepbound will be a big ask.

Biocon Expects US b(Humira) Market To Consolidate, Liraglutide Plans On Course

 

Biocon maintains it doesn’t expect the US to remain an eight to 10 player market for adalimumab biosimilars for long and also outlines expectations for its GLP-1 portfolio, led by liraglutide, seen as a major growth driver in the coming years.

Quick Listen: Scrip's Five Must-Know Things

 
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In this week's podcast edition of Five Must-Know Things: Amgen positions for obesity and diabetes; BMS returns TIGIT asset in pipeline reshuffle; is Kerendia the next jewel in Bayer’s crown?; Japan pharma firms cut jobs; and Sun Pharma seeks GLP-1 partner.

EMA’s PRIME Sees New Targets, More Approvals But Few Fast-Track Reviews

 

Nine new entries targeting a wide range of unmet medical needs. Several EU marketing approvals and two withdrawals. And an accelerated assessment tool that was seldom used. These were among the activities noted as part of the European Medicines Agency’s priority medicines scheme during the first half of 2024.

Lilly, With Tirzepatide Supply Issues Addressed, Raises Guidance By $3bn

 
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Lilly now expects to bring in between $45.4bn and $46.6bn in total revenue this year, thanks mainly to continued growth for Mounjaro and Zepbound.

Novo Pulls Wegovy Heart Failure Application, Will Resubmit To Get ‘Hard Endpoints’ In Label

 

However, Lilly already has outcomes data for tirzepatide, meaning Novo could lose the race to market with a heart failure claim even after being first to the US FDA.

Novo Nordisk Not Unnerved By ‘Quarterly Blip’

 
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Sales of Wegovy and Ozempic were strong again in the second quarter and while they were shy of analyst expectations, the Copenhagen-based giant is confident of continuing demand despite competition from Eli Lilly’s Zepbound.

Zevra’s Arimoclomol Use With Standard Of Care Complicates US FDA Adcomm Efficacy Assessment

 
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Determining the efficacy of arimoclomol alone in Niemann-Pick disease type C was challenging because most study subjects also received miglustat, an off-label drug in the US. An FDA official said panelists should assess arimoclomol’s efficacy as it was studied in the pivotal trial.

Quick Listen: Scrip's Five Must-Know Things

 
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In this week's podcast edition of Five Must-Know Things: Pfizer bullish on its oral glp-1; BMS’s rising confidence about Medicare pricing of Eliquis; more long term data for Leqembi; NewAmsterdam’s CETP inhibitor shows promise; and a look at Mankind’s Bharat Serums buy.  

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