Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerie, Agios, Amgen, Bayer, Biomarin, Boehringer Ingelheim, Chiesi, Heron, Innate, Menari, Moderna, Roche, Samsung, Shionogi, Sobi, UCB, Viiv.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA eyes grant of license for spectrometer for SARS; HQO eyes TAVI/TAVR for low-risk patients; ACLA says testing capacity beginning to strain.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioelectronics, Perkinelmer, Spiderwort, Wren Laboratories.
BOGOTA, Colombia and VANCOUVER, Canada – Anvisa, Brazil’s health care surveillance agency, re-started phase III trials for Coronavac, the COVID-19 vaccine candidate developed by China-based Sinovac Biotech Ltd., after a suspension of just two days. “Anvisa understands that it has sufficient subsidies to allow the resumption of vaccination,” the regulator said on Nov. 11. Anvisa said it plans to continue monitoring “the possible relationship of causality” between an unexpected serious adverse event and the vaccine.
The latest global regulatory news, changes and updates affecting biopharma, including: WHO maps end of the road for some tropical diseases; MHRA updates import licensing guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Apollomics, Bavarian Nordic, Halozyme, Janssen, Mycovia, Neonmind, Valeo, Vasomune.
Some PMA filings manage to scrape by at U.S. FDA advisory hearings, but the application for the Visability device by Refocus Group Inc. was not one of those. The panel voted 15-1 that the benefits of the device for presbyopia did not outweigh the risks, leaving the sponsor with a fundamental question about the viability of a technology that has been under development for more than 20 years.
Novocure Ltd. has scored another win, this time gaining the CE mark for the NovoTTF-100L system. As a result, Novocure plans to commercialize the device as a first-line treatment in combination with pemetrexed and platinum-based chemotherapy for unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM).
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