STAT+: Pharmalittle: India regulator finds 5% of drug samples are substandard; EMA claims new clinical trial registry is fixed

Hello, everyone, and how are you today? A steely gray sky is hovering this morning over the Pharmalot campus, where the official mascot has begun his latest round of hours-long snoozing. As for us, we are foraging for interesting stories and quaffing cups of stimulation, as you might have guessed. Our choice today is a Mardi Gras blend. We will leave it to you to guess what it contains. And how is your morning going? Is your schedule filled with meetings and deadlines and what-not? To help you along, here are some tidbits. Hope you conquer the world, and do keep us in mind when you see something fascinating. …

The European Medicines Agency has not identified any safety signals in the region related to the updated Covid-19 booster shot from Pfizer and BioNTech, Reuters notes. Last Friday, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention said that a safety monitoring system had flagged that the shot could possibly be linked to a type of brain stroke in older adults, according to preliminary data. In their own statement, the companies acknowledged that they were aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated booster.

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