New & Notable
Lilly's Zepbound–Taltz combo wins again in obesity, psoriasis study
Eli Lilly’s late-stage psoriasis study shows promising results for combining its obesity drug Zepbound with Taltz, potentially setting the stage for expanded approval.
FDA reverses course on Moderna’s flu vaccine
Moderna said after a “Type A” meeting, the agency agreed to move forward and review its application for the mRNA-based shot.
— BioPharma Dive
Viking Therapeutics pushes GLP-1/GIP obesity pill to phase 3
Viking Therapeutics is progressing the oral version of its leading drug candidate, VK2736, into phase 3 testing this year, following a mid-stage win.
FDA refuses to review Moderna’s mRNA flu vaccine
Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA communications and went against the regulator’s established guidance for flu shots.
— BioPharma DiveHims cancels plans to sell compounded GLP-1 pill after FDA backlash
— BioPharma DiveThe most valuable up-and-coming GLP-1s
— PharmaVoiceHealthcare Strategies: A Podcast
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A podcast for healthcare professionals seeking solutions to today's and tomorrow's top challenges. Hosted by the editors of Xtelligent Healthcare Media, this podcast series focuses on real-world use cases that are leading to tangible improvements in care quality, outcomes, and cost.
Guests from leading provider, payer, government, and other organizations share their approaches to transforming healthcare in a meaningful and lasting way.
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Latest News
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ConcertAI unveils agentic AI tool to cut trial timelines, costs
ConcertAI has rolled out Accelerated Clinical Trials, an agentic AI platform that can cut trial timelines by 10–20 months and study design time by up to 50%, the company says.
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Oracle launches AI data tool to expedite life sciences research
Oracle's new GenAI data platform was built to help pharmaceutical and life sciences companies speed up drug research and development using real-world health datasets.
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Fractyl Health's Revita reduces post-GLP-1 weight regain by ~70%
Fractyl Health's outpatient endoscopic procedure, Revita, reduces post-GLP-1 weight regain by ~70% after 6 months, midpoint cohort data shows.
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Roche's top obesity drug outperforms Wegovy in phase 2 trial
Roche's leading obesity drug achieved up to 22.5% weight loss in a mid-stage trial, reinforcing its bid to challenge market leaders Eli Lilly and Novo Nordisk.
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Novo expands diabetes partnership with Aspect Biosystems
Novo Nordisk and Canadian bioprinting company Aspect Biosystems build on their 2023 deal to develop cell-based treatments for diabetes.
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Trust concerns hinder agentic AI adoption, orchestration
Despite significant investment, most pharmaceutical and life sciences companies are struggling to bring agentic AI into production, a new report says.
Features
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5 emerging AI/ML trends in clinical research
Emerging AI and machine learning tools are reshaping clinical research as trial sponsors continue to grapple with rising costs, lengthy timelines and low success rates.
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5 trends defining the next wave of life sciences M&A
As the market rebounds, five key trends are shaping the next wave of mergers and acquisitions in the life sciences industry.
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GLP-1 drugs primed for FDA approval in 2026
With Pharma titans Eli Lilly and Novo Nordisk continuing to duke it out for control of the GLP-1 market, both are seeking FDA approval for new drugs this year.
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Blurring the line between GLP-1 compounders, counterfeiters
Weak regulatory oversight has allowed 503A compounding facilities to abuse customization rules, blurring the line between GLP-1 compounders and unregulated drug manufacturers.