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FDA grants EUA for Gilead’s investigational COVID-19 drug remdesivir

FDA grants EUA for Gilead’s investigational COVID-19 drug remdesivir

Remdesivir EUA status : The US has officially pushed the use of remdesivir for treating the novel coronavirus with the Food and Drug Administration (FDA) granting emergency use authorization (EUA) to the investigational COVID-19 drug candidate being developed by Gilead Sciences. The EUA lets the antiviral drug candidate to be used for the treatment of […]

Eiger BioPharmaceuticals doses first patients with Lambda in COVID-19 trial

Eiger BioPharmaceuticals said that it has dosed the first patients in a phase 2 trial of its hepatitis delta virus drug candidate peginterferon lambda (Lambda) in outpatients at the Stanford University School of Medicine having mild COVID-19. The California-based biopharma company said that nearly 120 patients will be randomly grouped in a 1:1 ratio to […]

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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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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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RECOVERY coronavirus trial : First patients enrolled in COVID-19 clinical trial by University of Oxford

RECOVERY coronavirus trial : University of Oxford researchers in the UK have initiated a coronavirus clinical trial called the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial. The RECOVERY clinical trial, which has enrolled the first patients, will test the effects of potential drug treatments for COVID-19 patients admitted to hospitals. The objective of the clinical […]

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Coronavirus home testing kit launched by US health tech company Nurx

US health tech company Nurx has unveiled a coronavirus home testing kit apart from launching an online coronavirus consultation service to address the COVID-19 pandemic, which has already infected more than 25,000 people in the US. The company claims to have seamlessly and safely connected people with testing, education, and care to slow down the […]

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Coronavirus vaccine trial : Moderna doses first subject with mRNA-1273 in phase 1 trial

Coronavirus vaccine trial : US biotech company Moderna has dosed the first participant in the phase 1 study of mRNA-1273, its mRNA vaccine against the novel coronavirus (SARS-CoV-2). The phase 1 coronavirus clinical trial is being carried out under its own Investigational New Drug (IND) application by the National Institutes of Health (NIH). mRNA-1273 is […]

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TenNor Therapeutics gets FDA orphan drug status for TNP-2092 in prosthetic joint infections

TenNor Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its multitargeting drug conjugate TNP-2092 for the treatment of prosthetic joint infections. According to the Chinese biopharma company, biofilm infections associated with prosthetic joints, central venous catheters, artificial heart valves, and other medical devices has become a huge challenge. […]

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Nabriva secures Xenleta FDA approval for community-acquired pneumonia

Xenleta FDA approval : Irish pharma company Nabriva Therapeutics has bagged approval from the US Food and Drug Administration for its semi-synthetic pleuromutilin antibiotic Xenleta (lefamulin) for the treatment of community-acquired bacterial pneumonia in adults. Community-acquired pneumonia is caused when someone develops pneumonia in the community, that is not in a hospital. Pneumonia is a […]

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TB Alliance bags Pretomanid FDA approval for highly drug-resistant TB

Pretomanid FDA approval : Non-profit organization TB Alliance has secured approval for Pretomanid Tablets in combination with bedaquiline and linezolid from the US Food & Drug Administration (FDA) for the treatment of highly drug-resistant forms of tuberculosis. The combination regimen was approved by the FDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD […]

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