Monday, October 21, 2024

FDA Office of Scientific Investigations (OSI) Requests for Bioresearch Monitoring (BIMO) Data for NDA/BLA Submission

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FDA has a Bioresearch Monitoring (BIMO) program and the BIMO program is managed by the Office of Scientific Investigations (OSI).  BIMO pro...
Saturday, September 28, 2024

Crossover design in confirmatory therapeutic trials

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This week, FDA approved a new drug called Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pi...
Monday, September 23, 2024

The Role of Radiolabeling in Clinical Studies: Exploring Lung Deposition and Mass Balance Studies

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Radiolabeling is an advanced and valuable technique in clinical research that enables scientists to trace the journey of drugs through the h...
Sunday, September 08, 2024

Patents vs. Trade Secrets: Understanding the Best Approach for Your Innovation and Invention

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In today’s competitive business landscape, protecting intellectual property (IP) is critical. Whether you’re an inventor developing a ground...
Friday, August 30, 2024

Understanding Patent and FDA Exclusivity: Protecting Innovation and Encouraging Drug Development

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In the world of pharmaceuticals, innovation is the lifeblood of progress. Developing a new drug is an incredibly complex and expensive proce...
Friday, August 23, 2024

Estimand Framework - discussions at JSM 2024

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In the Joint Statistical Meetings 2024 , there was a session "Global Impact of the ICH E9(R1) Addendum - 5-Year Anniversary for the Tri...
Sunday, July 28, 2024

Five most frequently used strategies for handling intercurrent events

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The original ICH E9 guideline, titled " Statistical Principles for Clinical Trials ," was established in 1992. An updated version,...
Wednesday, July 24, 2024

Clinical trial succussed in phase 2, but failed in phase 3

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Clinical trials are the backbone of drug developments, acting as the gateway between laboratory research and practical, commercial, real-wor...
Sunday, June 23, 2024

Elevidys in DMD: Approved Despite Trial Failed in Primary Efficacy Endpoint

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The US Food and Drug Administration has given the green light for the first gene therapy that treats a rare form of muscular dystrophy ( Du...
Wednesday, June 19, 2024

Functional Unblinding in Double-blind, Randomized, Controlled Trials (RCTs)

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Earlier this month,  FDA advisory committee declined to endorse Lykos Therapeutics’ application to market its psychedelic drug MDNA, also k...