Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Codon

JANUARY 21, 2024

You can do a challenge trial with deadly diseases, but you need a “rescue therapy.” With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. What is your pitch for them?

Vaccine 111

Vaccine Trials Disease Virus 111

Codon

MARCH 14, 2023

For every 5,000 drug compounds tested in mice, five move into human studies. The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies. Nobody really knows why.

DNA 52

DNA Laboratories Animal Testing Engineering 52