The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ACLA sees need for clarification of test coverage; MITA seeks transparency at USPSTF; NIH eyes license for cancer therapy; GAO says federal agencies falling short on recommendations; TGA updates guidance for risks in drugs and devices.
Investors appear to be maintaining a bullish outlook on biopharma companies developing innovative medicines, with the BioWorld Drug Developers index currently tracking up over 5% in value so far this month heading into third-quarter earnings season.
Exploring new regulatory territory, Iovance Biotherapeutics Inc. hit a snag that will delay the submission of the BLA for its tumor-infiltrating lymphocyte (TIL) therapy, lifileucel (LN-144), in metastatic melanoma.
A first half of the year progress report from the international advocacy group Alliance for Regenerative Medicine finds that the regenerative medicine and advanced therapy sector is in very good shape and has performed well in terms of both clinical development and fundraising.
A first half of the year progress report from the international advocacy group Alliance for Regenerative Medicine (ARM), finds that the regenerative medicine and advanced therapy sector is in very good shape and has performed well in terms of both clinical development and fundraising despite the challenges posed by the ongoing COVID-19 pandemic.
