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FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products
expresspharma
July 23, 2020
The US FDA is revising the guidance to reflect that FDA generally intends to exercise enforcement discretion with respect to IND and premarket approval requirements for certain HCT/Ps through May 2021.
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Glenmark announces top-line results from Phase 3 clinical trial of favipiravir for COVID-19 treatment
expresspharma
July 23, 2020
The study evaluated the efficacy and safety of favipiravir plus standard supportive care, versus standard supportive care alone, in mild to moderate patients of COVID-19.
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Queen’s University awarded grant to research bacterial co-infections in COVID-19
expresspharma
July 23, 2020
The grant is one of only five projects supported in the UK by the Biotechnology and Biological Sciences Research Council (BBRSC) and will last eighteen months.
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Just - Evotec Biologics Wins COVID-19 DoD Contract
contractpharma
July 23, 2020
To develop and manufacture monoclonal antibodies (mAbs) for treatment and/or prevention of COVID-19.
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Piramal Critical Care, Medivant Enter Strategic Injectables Alliance
contractpharma
July 23, 2020
Aims to address the shortage of injectable drugs in hospitals across the U.S. or COVID-19 patients.
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Rigel Announces Trial of Fostamatinib for COVID-19 Pneumonia
americanpharmaceuticalreview
July 22, 2020
Rigel Pharmaceuticals announced the initiation of an investigator-sponsored trial (IST) being conducted by Imperial College London to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of COVID-19 ...
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Enzychem Files IND for Phase 2 Study of EC-18 in Preventing ARDS Due to COVID-19 Pneumonia
americanpharmaceuticalreview
July 22, 2020
Enzychem Lifesciences has filed an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for a Phase 2 clinical trial of EC-18 as a preventative therapeutic against Acute Respiratory Disease Syndrome (ARDS) due to ...
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Partnership to fight COVID-19 medication counterfeiting and advance blockchain solutions
europeanpharmaceuticalreview
July 22, 2020
The alliance between Chronicled and Deloitte intends to enhance security and efficiency in the pharma supply chain by bring to market new blockchain-powered solutions.
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Six people tests coronavirus positive in Maha FDA
expresspharma
July 22, 2020
Six staff of the Maharashtra Food and Drug Administration’s (FDA) have tested coronavirus positive.
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Wave of promising study results raises hopes for coronavirus vaccines
expresspharma
July 22, 2020
Whether any of these efforts will result in a vaccine capable of protecting billions of people and ending the global pandemic that has claimed more than 600,000 lives is still far from clear.