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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Development of Additive Manufacturing, American College of Cardiology, Butterfly Network, Castle Biosciences, Cb Scientific, Curvafix, Dexcom, Eli Lilly, Fondazione Michelangelo, Fortanix, Fresenius, Intel, Isoplexis, Livongo, Mango Wellness, Microsoft, Mölab, My Cardia Thailand, Mybio, Nanovibronix, Nec Oncoimmunity, Oncocyte, Palmetto GBA Moldx, Rhythm AI, Scanwell Health.
Keeping you up to date on recent developments in diagnostics, including: Improving sensitivity of COVID-19 tests; Deep learning algorithm helps triage suspected COVID-19 cases; Cancer image analysis tool incorporates HER2 biomarker assay.
The ongoing pandemic brought about several challenges for investors looking for the next big thing, but some areas still have experienced growth. Experts addressed this topic and other issues during a panel discussion Oct. 6 at the Cleveland Clinic’s 2020 Medical Innovation Summit.
The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada explains COVID-19 disclosures; TGA on changing sponsor details; FDA awards research grants for rare diseases; Se habla español.
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