This Week’s Biotech Highlights

This week in biotech, regulators ran amok.

On the plus side, the FDA approved two new drugs this past week, including one — prostate cancer drug Jevtana — months ahead of the FDA’s deadline.

The FDA also moved this week to regulate LDTs (laboratory developed tests) more closely. Most direct-to-consumer (DTC) genetic tests fall into this category, and a series of letters from the FDA to DTC manufacturers last week is evolving into broader action.

Health Canada also took action this week, with the goal of soliciting reports of adverse drug reactions directly from patients. Unfortunately, the benefits of this approach will be hard to realize unless they develop a consumer-friendly form to go along with the new policy.

For more regulatory news, deal news and news of anyone running amok in biotech, stay tuned to The Cross-Border Biotech Blog and @crossborderbio on Twitter.

Comments are closed.