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CytoAgents, Quotient Sciences to take COVID-19 drug candidate GP1681 into human trials

US biotech company CytoAgents has joined forces with CDMO and CRO services provider Quotient Sciences to accelerate the development of its COVID-19 drug candidate GP1681 into human clinical trials for the treatment of cytokine storm. According to the partners, scientific consensus is building that severe illness resulting from COVID-19 and other infectious diseases is triggered by […]

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Citius seeks FDA nod for evaluating stem cell therapy for ARDS in COVID-19

Citius Pharmaceuticals has made a Pre-IND submission to the US Food and Drug Administration for a novel stem cell therapy for acute respiratory distress syndrome (ARDS) in COVID-19 patients. In this regard, the late-stage specialty pharma company submitted a pre-IND meeting request and supporting briefing documents to the FDA’s Center for Biologics Evaluation and Research […]

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GS COVID-19RT-PCR diagnostic test : GenoSensor secures FDA EUA status

COVID-19 diagnostic test : GenoSensor has been granted emergency use authorization status from the US Food and Drug Administration (FDA) for its GS COVID-19 real-time reverse transcription-polymerase chain reaction (RT-PCR) diagnostic kit. According to the genomic technology company, the kit has been developed to generate accurate and reproducible quality results to help in clinical decision-making […]

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SARS-CoV-2 vaccine trial : Sinovac Biotec begins COVID-19 vaccine candidate human trial

SARS-CoV-2 vaccine trial : Chinese biopharma company Sinovac Biotech has started a phase 1 clinical trial for SARS-CoV-2 vaccine, its COVID-19 vaccine candidate in 144 healthy adults, aged between 18 and 59. Sinovac Biotech had recently secured approval from China’s National Medical Products Administration (NMPA) to launch the randomized, double-blinded, placebo-controlled study for the coronavirus […]

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Oxford University ChAdOx1 nCoV-19 vaccine trial begins in humans

Researchers at the University of Oxford in the UK have commenced the ChAdOx1 nCoV-19 vaccine trial in healthy human volunteers to test the vaccine candidate’s ability in protecting against the novel coronavirus. Nearly 1,100 people, aged between 18 and 55 are taking part in the Oxford University coronavirus vaccine trial, of which half of them […]

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DNA-based COVID-19 vaccine candidate being developed by University of Waterloo

DNA-based COVID-19 vaccine candidate : Researchers at the University of Waterloo in Canada are developing a DNA-based vaccine candidate which can be given via nasal route to protect from novel coronavirus. The vaccine will be formulated to work on tissues in the nasal cavity and lower respiratory tract which will enable it to replicate within […]

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Vaccine giants Sanofi, GSK announce COVID-19 vaccine partnership

French pharma company Sanofi has announced a COVID-19 vaccine partnership with GlaxoSmithKline (GSK) to develop an adjuvanted vaccine for the novel coranavirus, by combining their drug discovery technologies. Sanofi will provide its S-protein Covid-19 antigen based on recombinant DNA technology to the partnership. The technology is said to be used for generating an exact genetic […]

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Rutgers University’s saliva-based COVID-19 test gets FDA approval

New Jersey-based Rutgers University’s RUCDR Infinite Biologics and its collaborators have been granted emergency use authorization (EUA status) for their saliva-based COVID-19 test by the US Food and Drug Administration (FDA). The new COVID-19 test uses saliva as the main test biomaterial for the SARS-CoV-2 coronavirus. The EUA status permits the immediate use of saliva […]

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Sinovac Biotech gets approval to begin coronavirus vaccine trial

Coronavirus vaccine trial : Chinese biopharma company Sinovac Biotech has secured approval to carry out a human clinical trial on an inactivated COVID-19 vaccine candidate, which it had been developing since late January. The company said that its scientists have quickly wrapped up comprehensive preclinical studies in collaboration with some of the top academic research […]

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Second EUA issued by FDA to decontaminate N95 respirators for reuse

The US Food and Drug Administration (FDA) has granted the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. The regulator said that the EUA will support decontamination of nearly 750,000 N95 respirators per day in the country. The emergency use authorization has […]

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