FDA Decision for Sarepta’s Gene Therapy for DMD Sets New Regulatory PrecedentHistoric Regulatory Decision for First FDA-Approved Gene Therapy for DMDAug 10, 2023Aug 10, 2023
New Weapons Emerge in the Fight Against Respiratory Syncytial Virus (RSV)Imagine your newborn baby has been hospitalized with a serious respiratory infection and is struggling to breathe. That’s a reality for…Aug 10, 2023Aug 10, 2023
Communicating the Complexities of Subgroup Analyses at an AdComWithin clinical trials, exploratory or post-hoc subgroup analyses are widely recognized as only “hypothesis generating” due to their high…Aug 10, 2023Aug 10, 2023
Quick Snips: CRISPRCRISPR is a powerful gene-editing tool that enables targeted therapeutic gene editing, with clinical applications for improving treatment…Aug 9, 2023Aug 9, 2023
Neurology Takes a Page Out of the Oncology Playbook of FDA Accelerated ApprovalsThe field of neurology is experiencing a significant upswing in innovative therapeutic development, propelled by advances in genetics…Aug 9, 2023Aug 9, 2023
The Rise of ChatGPT in the Pharma IndustryArtificial Intelligence (AI) is rapidly transforming how we work, and the pharmaceutical industry is no exception. In particular, the…Aug 9, 2023Aug 9, 2023
Thinking Outside the Beta-Amyloid BoxThe dominant amyloid hypothesis of AD has translated into an armada of anti-amyloid biologics in the near-term pipeline — led by Eisai and…Aug 9, 2023Aug 9, 2023
Multiple Data Sources Show That Decentralized Clinical Trials Pay OffTraditional clinical trials are typically conducted at central locations or sites that patients must travel to in order to be evaluated and…Aug 9, 2023Aug 9, 2023
Regulatory Policy Watch: The FDA Is Taking Accelerated Approval Pathway Reforms Into Their Own…On September 30, 2022, President Biden signed into law the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), which will be…Aug 9, 2023Aug 9, 2023