The Immune System: Friend & Sometimes Foe

Emily BurkeAuthor Emily Burke PhD, Biotech Basics, Edited by Sarah Van Tiem, Immune System, Immunotherapy

The Immune System: Friend & Sometimes Foe The immune system. Yes, everybody has one. It’s pretty important to our health. But what the heck is it? In short, the immune system is a complicated network of organs, cells, and signaling molecules. Without this guardian, we fall prey to dangerous pathogens and toxic substances in the environment. The immune system can … Read More

Groundbreaking Migraine Drug Explained

Emily BurkeAuthor Emily Burke PhD, Drug Approvals, Drug Development, Drug Discovery, Drug Targets, Edited by Sarah Van Tiem, Migraine

FIRST IN CLASS MIGRAINE APPROVAL Last month the FDA approved Amgen’s (Thousand Oaks, CA) new migraine drug Aimovig, the first drug shown to prevent the onset of migraines. The drug significantly reduces the number of migraine days in difficult-to-treat (those that have failed 2 to 4 prior treatments) patient populations. In some patients dubbed “super responders”, migraines occurrence went from several times/month to no occurrence for 6 … Read More

From Drug Development To Approval: Phase III

Emily BurkeAuthor Emily Burke PhD, Drug Approvals, Drug Development, FDA, The WEEKLY

Phase III Is No Guarantee Our last Biotech Primer WEEKLY explored the riskiest part of the human clinical trials pathway: Phase II. About 70% of drugs that enter Phase II never make it out. Most often, it’s because they fail to demonstrate effectiveness. Even making it to Phase III is no guarantee of success – about 40% of drugs fizzle … Read More