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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ac Immune, Alliance Family of Companies, Applied DNA Sciences, Battelle, Caretaker Medical, Cerner, Clinical Laserthermia Systems, Columbia University, DNA Labs International, Freedom Innovations, Haliodx, Induction, Medalliance, OSU Wexner Medical Center, Osmind, Ottobock, Pacific Edge, Paltown Development Foundation Proteor, Providence, Southwest Labs, Stratus, Tegria, Thermo Fisher Scientific, Votis.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cartiheal, GE Healthcare, Varian.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation; AMA adds codes for COVID-influenza testing; MedPAC concerned about post-pandemic telehealth; CMS: CLIA audits yield cease-and-desist letters.
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