The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Medicare overpaid for facet-joint injections; FDA posts IIE policy for non-COVID tests.
Johnson & Johnson said it has temporarily paused further dosing of its adenoviral vector-based COVID-19 vaccine candidate, JNJ-78436735, due to an unexplained illness in a study participant. Trial enrollment is also on hold while the company awaits a recommendation on how to proceed from the study's data safety monitoring board.
An NIH-sponsored phase III trial testing Eli Lilly and Co.'s SARS-CoV-2 neutralizing antibody candidate, LY-CoV555, alongside the Gilead Sciences Inc. antiviral Veklury (remdesivir) has been paused at the request of its data safety monitoring board, the company told BioWorld.
LONDON – Apogenix GmbH has added its CD95 ligand inhibitor, asunercept, to the band of cancer immunotherapies that are being repurposed to treat the most severe effects of COVID-19 infection.
The latest global regulatory news, changes and updates affecting biopharma, including: Retiring lawmakers urge 340B modernization; How human are ‘human antibodies’?; ANDA suitability MAPP updated; MHRA: Drug interactions possible with COVID-19.
NEW DELHI – India’s digital health market is poised to grow rapidly over the next five years propelled by the COVID-19 pandemic, according to two new reports.
PARIS – A consortium that includes Therapanacea SAS, GE Healthcare France SAS, Orange Healthcare SA, the AP-HP group of 39 hospitals in the Paris region and the French academic society for thoracic imaging has created a database for COVID-19.
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