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GLP-1 Receptor Agonists: Clinical Trial Considerations

The U.S. Food & Drug Administration (FDA) has approved certain GLP-1 drugs for commercialization and use, including liraglutide (Victoza®), semaglutide (Ozempic®, Wegovy®), and tirzepatide (Mounjaro®, Zepbound®). Although...more

Antibody Drug Conjugates Keep Growing: What You Need to Know

What Are ADCs and Why Are They Growing? Over the past few years economic headwinds have resulted in fewer deals, with companies and private equity firms alike reassessing where to spend money. But one portion of the...more

Cancer Drugs: Clinical Trial Issues for Antibody Drug Conjugates (ADCs)/Antibody Therapeutics

Antibody Drug Conjugates (ADCs) are a class of small molecule drugs (also known as a payload) and an antibody conjugated together by a chemical linker. ADCs are designed to target specific cells, such as cancer cells, while...more

Decentralized Clinical Trials: Diversity in Clinical Trials

The U.S. Food and Drug Administration (FDA) has demonstrated a commitment to expanding diversity in clinical trials. Decentralized Clinical Trials ( DCTs) contribute to this effort by enhancing convenience for trial...more

FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance

On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more

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