Keeping Track: Opana ER Abuse Deterrence Claim Withdrawn; Third Neulasta Biosimilar Submitted; Keytruda Cleared In Head And Neck Cancer

The heat of August saw a new biosimilar sponsor, Coherus BioSciences Inc., reach FDA with a filing under the still-emerging 351(k) pathway, but also saw a competitor drop out of the quest for an abuse deterrent claim for a long-acting opioid.

Heron Therapeutics Inc.'s long-acting anti-emetic Sustol finally received approval from FDA, nearly seven years after new drug application (NDA)...