The Revogene SARS-CoV-2 test from Meridian Bioscience could give false-negative results because of the latest coronavirus variant. The good news is that the diagnostic hasn’t been distributed in the US, the FDA says.

The impending implementation of the EU's new Medical Device and IVD Regulations will cause most firms to pull select legacy devices and in vitro diagnostics from the EU market, a survey of 169 quality and/or regulatory professionals finds. The survey also revealed that companies are in hiring mode as the compliance dates for both regulations approach. Quality and regulatory officials from Abbott Laboratories and Meridian Bioscience weigh in.

Several biologic drugs are now available for the 10% of asthma patients with severe uncontrolled disease, and Dupixent could join them later this year, setting the therapy area up for a competitive showdown.

The competitive dynamics in the pharmaceutical sector appear to be intensifying, with second- and third-to-market drugs reaching the market faster behind first-in-class drugs. That's putting more pressure on new drug launches and impacting drug pricing and rebating strategies.