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Viking data suggest obesity drug could rival Zepbound, Wegovy

Bio Pharma Dive

The biotech’s drug led to significant weight loss in a Phase 2 trial, causing shares to double as analysts compared results to the marks set by drugs from Eli Lilly and Novo Nordisk.

Drugs 306
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Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Bio Pharma Dive

The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.

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Bristol Myers says KRAS drug succeeds in key trial

Bio Pharma Dive

Confirmatory results for Krazati, which Bristol Myers acquired via its buyout of Mirati, could help the drug win full approval while Amgen has been set back.

Drugs 293
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Madrigal wins FDA approval of first drug for MASH

Bio Pharma Dive

But its sales potential is unclear, and competition could emerge from popular weight loss drugs. Rezdiffra’s clearance is a turning point in the fight against the liver disease.

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Commercial Drug Sourcing for Clinical Trials

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Watch this video to learn more about what to look for when selecting a commercial drug sourcing specialist, as well as Catalent’s approach to this process.

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FDA accepts Shorla’s oral liquid leukaemia drug NDA

Pharmaceutical Technology

The FDA has approved the NDA for SH-201, an oral liquid drug that slows or stops the growth of certain types of leukaemia.

Drugs 264
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Diagonal starts up with $128M to make better ‘activator’ antibody drugs

Bio Pharma Dive

The startup claims to have a more efficient way to develop biologic drugs that treat disease by turning on cellular pathways, rather than blocking them.

Antibody 286
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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and (..)

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development?

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.