Drugs & Pharmaceuticals

News and analysis on drug development, clinical evidence, regulatory approvals, pharmacology, and the science behind treatments — from small molecules to biologics.

Let's all Shed a Tear for the Pharmaceutical Industry

Last week, Merck filed suit against the US Department of Health and Human Services to prevent them from implementing drug pricing provision of the Inflation Reduction Act.

The Story You Thought You Knew About Thalidomide and Birth Defects is All Wrong

Enantiomerism – the property of asymmetric molecules that look "the same" but are actually mirror images of each other – is one of the many topics, perhaps the most egregious, that drive organic chemistry students bats###t crazy.

Pull Incentive for Antibiotic R&D from Europe

As many of you know, I spent many working days in Europe during my career and I still live there several months a year. In fact, I’m currently in a rather cool, wet Europe.

FDA’s ‘Accelerated Approval’ Pathway for Drugs is Important, But Imperfect

During my years as an FDA official, I learned that there is a fundamental fact of life that underlies all drug testing and regulatory review: The data are seldom as complete and unequivocal as you might like.

Will Pfizer's New Weight Loss Pill Silence the Ozempic Commercials?

It would be so delightful, even life-affirming, to get Novo Nordisk's execrable O-O-O-Ozempic TV ad off the air, or even reduce its malevolent presence. While there is no shortage of cringe-worthy TV ads (am I the only one

The CDC data are based on all cases reported to the national poison data system, the American Association of Poison Control Centers’ dataset. Between 2012 and 2021, 260,435 pediatric ingestions of melatonin were reported, 2.25% of the total.