Eye on FDA

AUGUST 4, 2021

When Breakthrough Therapy (BT) designation is granted, then the drug gets Fast Track status and receives more intensive guidance – which can begin as early as Phase I clinical trials. That said, BT would be a lagging indicator since it can be granted so early in the development process.

Clinical Pharmacology 122

Clinical Pharmacology Compounding Vaccines 122

Eye on FDA

JANUARY 5, 2022

Of note, this tally does not include meetings of the Vaccines and Related Biologic Products Advisory Committee held to consider a recommendation for COVID-19 vaccines, but includes only drugs and biologics. FDA Adcomms have been declining in number even as the agency approves more drugs.

Clinical Pharmacology 76

Clinical Pharmacology Vaccines Compounding Diabetes 76

Pharmaceutical Technology

DECEMBER 16, 2022

Novel therapeutics and vaccines for malaria. This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology. Pyramax was codeveloped by MMV and the South Korean company Shin Poong.

Drug Development 105

Drug Development Vaccines Clinical Pharmacology Compounding 105