EU OKs coronavirus test from Macrogen | Dosing initiated for Innovent Bio's IBI322 in China | Atossa to advance trial for COVID-19 nasal spray
August 6, 2020
DIA Global SmartBrief
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European regulators have given CE mark approval to South Korea-based Macrogen for its Axen COVID-19 RT test that can deliver results within two hours.
Full Story: FDAnews (8/4) 
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Clinical NLP reveals deeper oncology insights
Specific oncology concepts important in understanding cancer progression are often unavailable in structured formats. Manual review of unstructured data is labor intensive and expensive. See how an oncology-focused natural language processing (NLP) system addresses these challenges.
Asia Pacific
Innovent Biologics announced it has dosed the first patient for its early-stage trial in China for IBI322, a recombinant anti-CD47/PD-L1 bispecific antibody designed to treat advanced malignancies in patients who failed standard therapy. The trial will assess the drug's initial anti-tumor efficacy, safety and tolerability.
Full Story: Seeking Alpha (free registration) (8/3) 
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A trial will be launched in Australia by Atossa Therapeutics to test the safety and tolerability of its experimental nasal spray AT-301 as a potential COVID-19 treatment after the study received clearance from Australian regulators. The nasal spray is designed to be used at home to decrease COVID-19 symptoms and decelerate the infection rate so the patient's immune system can combat the SARS-CoV-2 virus.
Full Story: Seeking Alpha (free registration) (8/3) 
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Study: Clinical data strategies & digital transformation
How are organizations managing the rapidly evolving data landscape? Learn about the impact of data on clinical performance and efficiency, and how to leverage automation and AI to enhance analytics capabilities. View study results.
North America
The NIH will launch two clinical trials, one each for inpatients and outpatients, as part of its Accelerating COVID-19 Therapeutic Intervention and Vaccines program to test the safety and efficacy of Eli Lilly's monoclonal antibody LY-CoV555 as a potential treatment for patients in the early stages of a COVID-19 infection.
Full Story: NBC News (8/4) 
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BioSight's investigational drug BST-236, or aspacytarabine, gained the FDA's Fast Track designation as a treatment for adults with acute myeloid leukemia aged 75 years or older or for those unable to undergo induction chemotherapy. The agent is a novel antimetabolite being tested in a Phase IIb trial, and another midstage trial for BST-236 will be launched later this year to test the drug in patients with relapsed/refractory AML, or myelodysplastic syndrome.
Full Story: Healio (free registration) (8/4) 
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The FDA has updated its searchable online Purple Book Database, and it now includes all biological products licensed by the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. "The Purple Book Database is intended to improve transparency and functionality for stakeholders by providing a complete view of biological product options, including whether there are biosimilar and/or interchangeable product options," the FDA noted.
Full Story: Regulatory Focus (8/3) 
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The COVID R&D Alliance has enrolled the first patients in a platform trial testing Amgen's Otezla, Takeda's Firazyr and AbbVie's experimental cenicriviroc as therapeutics in patients hospitalized with COVID-19. Twenty-one drugmakers are part of the alliance and are working in collaboration with Quantum Leap Healthcare Collaborative and the FDA.
Full Story: BioPharma Dive (8/3) 
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