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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apellis, Bold, Caladrius, CSL, Emergent, Gilead, Grifols, Pfizer, Rigel, Sobi, Sumitomo Dainippon, Takeda, University of Oxford.
COVID-19 stalled clinical trials, halted elective surgeries, and body slammed many med-tech companies’ revenues. Despite that, an industry report released by Ernst & Young (EY) finds that the pandemic also drove some positive changes in the med-tech industry including long-neglected attention to enterprise-wide business continuity.
LONDON – Industry is calling on the government to set out a plan for the safe and sustainable restart of non-COVID-19 clinical studies that were put on hold when the pandemic struck.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Instructions needed for self-sampling from nares; House Dems blast FDA decision on lab test review; DOJ take-down identifies massive telehealth fraud; Health Canada explains COVID-19 disclosures; GAO says FDA lab safety office lacks teeth.
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