One of the few surgical procedures that does not routinely involve closing tissue is a lumbar discectomy to repair a disc herniation, because up until recently there has been no easy and effective technique. The standard of care is to let the surgical opening attempt to heal on its own. However this neglect results in roughly 15% of cases requiring reoperation due to reherniation. Anulex Technologies Inc.’s Xclose tissue repair system provides surgeons with the opportunity to approximate and close the tissue of the anulus fibrosus immediately following a discectomy.

Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.