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.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has approved an additional indication for CT-P59, Incheon-based Celltrion Inc.’s anti-COVID-19 monoclonal antibody.
Astrazeneca plc said it has received about $486 million from the U.S. government to support the development and supply of a long-acting antibody combination under evaluation for the prevention and treatment of COVID-19. Phase III trials of the candidate, AZD-7442, are slated to begin later this month, the company told BioWorld. One trial will enroll more than 6,000 adults for the prevention of COVID-19 with additional trials set to enroll about 4,000 adults for the treatment of the infection, the Cambridge, U.K.-based company said.
LONDON – The first confirmed case of COVID-19 reinfection in the U.S. has been reported, with a patient testing positive for two distinct SARS-CoV-2 strains within 48 days, while testing negative in between contracting the two infections.
The latest global regulatory news, changes and updates affecting biopharma, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Avenue, Astrazeneca, Celltrion, Gannex, Immunomedics, Oncopeptides, Oxular.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altimmune, Antengene, Auravax, Bausch, Cstone, Curon, Eyenovia, Hitgen, Innocan, Ligand, Novabay, Pfizer, Rhizen, Wuxi.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Genmark Diagnostics, Oxford Nanopore.
As clinical trials, halted due to the COVID-19 pandemic, begin to resume and biopharma companies find workarounds to keep the research going, activity in phase I, II and III studies picked up by more than 40% in September.
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