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Creating a COVID-19 Safety Toolkit for pharmaceutical businesses
Marta Kalas explains how to develop a COVID Safety Toolkit to ensure pharmaceutical businesses comply with changing regulations.
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Trial to evaluate monoclonal antibody therapy for mild-to-moderate COVID-19
The study will determine if the combination of BRII-196 and BRII-198, two investigational antibodies for SARS-CoV-2, can prevent disease progression.
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Novel COVID-19 test could significantly reduce testing time
The new COVID-19 test, called RTF-EXPAR, was able to accurately detect the presence of SARS-CoV-2 viral RNA in under five minutes.
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FDA approves Ebanga (Ansuvimab-zykl) for the treatment of Ebola
Ebanga was approved based on its ability to reduce 28-day mortality in patients with confirmed Ebolavirus infection.
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First long-acting HIV treatment approved in Europe
The European Commission approval of the long-acting injectable HIV treatment could transform the lives of people living with the disease.
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Moderna’s COVID-19 vaccine is 94 percent effective, according to trial results
Phase III trial data suggests the mRNA-1273 vaccine is safe and highly effective at preventing COVID-19 in adults.
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Concerns raised over India’s approval of COVID-19 vaccine with incomplete data
The All India Drug Action Network has said it is "shocked" India has given approval to Covaxin, a COVID-19 vaccine with a lack of peer reviewed safety and efficacy data.
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EC orders additional 80 million doses of Moderna’s COVID-19 vaccine
Europe will receive an extra 80 million doses of Moderna's mRNA-1273, a COVID-19 vaccine candidate, following the EC's decision.
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First hospitalised COVID-19 patient dosed in FSD201 treatment trial
The study will evaluate whether FSD201 is safe and of benefit to hospitalised patients with COVID-19, in combination with standard of care.
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Phase I/II trial initiated to study VLA2001, potential COVID-19 vaccine
Valneva has initiated its Phase I/II trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
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Current innovations in the vaccine pipeline
As the global COVID-19 response continues, so does the rapidly expanding pipeline for a novel COVID-19 vaccine. Here, experts from Avalere Health outline ongoing US and global vaccine development efforts, including the role of public-private partnerships in accelerating vaccine development. They will also focus on the broader context of respiratory…
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Many people may not receive a COVID-19 vaccine until 2022
Studies show that more than a fifth of the global population, mostly in low- and middle-income countries, may have to wait until at least 2022 to receive a COVID-19 vaccine.
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New opportunities for the global API market
Active pharmaceutical ingredients (APIs) are primary components in the manufacture of drugs, yet this global market experiences numerous challenges. Regulatory pressure, pricing arbitrages, a shift to digital manufacturing and patents for blockbuster drugs are chief among them, but the COVID-19 pandemic added a further hurdle as governments globally decided to…
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COVID-19 challenge trials: is there a compelling ethical argument against?
Ethicist says that, should trials offer the huge benefits and low risks, he finds no compelling ethical objection to challenge trials for COVID-19 vaccines.
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Raman spectroscopy: a useful tool in the fight against COVID-19
Raman spectroscopy has numerous applications in the pharmaceutical industry, ranging from verification of raw materials to quality control of products. This article explores how researchers are using the technique to aid our understanding of SARS-CoV-2, potentially improving detection speed and methods of analysis.
