New FDA Specialty Approvals
✦ July 9: The FDA gave an additional approval to Astellas Pharma US, Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who ...
News Briefs
✦ Bristol Myers Squibb will voluntarily withdraw the U.S. indication for Opdivo (nivolumab) as a monotherapy for people with hepatocellular carcinoma who previously were treated with sorafenib. The move follows an...
Zeposia May Have Challenges Within Ulcerative Colitis Class
A recently approved product in the ulcerative colitis therapeutic class brings a new mechanism of action. However, according to payers responding to a survey by Zitter Insights, the treatment — Bristol Myers Squib...
News Briefs
✦ Merck & Co., Inc. will voluntarily withdraw the accelerated approval indication for Keytruda (pembrolizumab) for the treatment of people with recurrent locally advanced or metastatic gastric or gastroesophag...
New FDA Specialty Approvals
✦ June 7: The FDA granted another indication to Alexion Pharmaceuticals, Inc.’s Ultomiris (ravulizumab-cwvz) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in children at least 1 month old and ad...
Employers Have Variety of Approaches for High-Cost Drugs
As more high-cost drugs, including one-time gene therapies, come onto the market, employers are considering implementing a variety of contracting models to make sure their employees have access to these agents. Howe...
Prime Rolls Out New Medical Benefit Management Offering
As payers continue to look for ways to tackle the rising spending on specialty drugs, Prime Therapeutics LLC is launching a medical drug management program. Known as MedDrive, the offering will be rolled out in phas...
Offering Patients Money to Switch Drugs May Become PBM Tool
PBMs have used formulary exclusions as an effective way to negotiate with manufacturers for several years. However, at least one payer has gotten more aggressive with its tactics to get members to move from an exclu...
News Briefs
✦ The U.S. Supreme Court denied a petition from Novartis AG’s Sandoz unit to review the 2020 Federal Circuit decision to uphold two patents of Amgen Inc.’s Enbrel (etanercept). The FDA approved Sandoz’s Enbr...
New FDA Specialty Approvals
✦ May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of loca...