Alkem’s ‘affordable’ cetuximab biosimilar set to take on Erbitux in India, even as Merck KGaA pursues a court case seeking information and data related to efficacy and interchangeability of the Indian company's product.

Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight. 

CBER’s Marks said US FDA is working with Novavax on manufacturing to allow its protein-based vaccine to be ready for a fall roll-out. After some concerns about international coordination, multiple regulators seem to be settling on a monovalent approach for fall vaccinations.

The Swiss major should have a considerable first-to-market advantage over other IL-17 biologics from the likes of UCB and Acelyrin that are also targeting the hidradenitis suppurativa space.