The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services, First Coast Services Options, Livanova, Medline Industries, National Institute for Health and Care Excellence, Novitas Solutions
Matthew Ros, chief strategy and business officer for Epizyme Inc., said the company is “not providing specific guidance at the moment” about the sales force that will be deployed to market Tazverik (tazemetostat) in follicular lymphoma (FL), an indication for which U.S. regulators are considering the oral, first-in-class EZH2 inhibitor. “But I can assure you we’ve planned very thoughtfully” about the effort, he said. “That's always been a part of why we thought epithelioid sarcoma [ES] was such a strategically important component of the overall business strategy to get on-the-ground experience.” The sales force numbers 19 for now.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Cowen Washington Research Group, European Commission, GE Healthcare
Whether large or small, or based in the U.S. or abroad, life sciences companies are an increasingly attractive target for shareholder suits. The number of securities fraud class action suits filed in the U.S. in 2019 across all industries totaled 404, just one more than the 403 cases filed in 2018 and down from the peak of 412 in 2017, according to a new Dechert LLP report.