Two new projects have begun, one on standardizing the assessment of immune responses in individuals vaccinated in clinical trials, the other to improve understanding of potential immunity in patients who have been infected with SARS-CoV-2.

Avenu’s Ellipsys vascular access system is an ultrasound-guided catheter to create a durable arteriovenous fistula for patients undergoing dialysis.

Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals. 

China is set to grant priority reviews to major biologics from Roche, the first CAR-T therapy from Wuxi Juno, and breakthrough therapy designation to a pediatric respiratory antiviral from ArkBio.