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Vancouver, Wash.-based drugmaker CytoDyn is seeking an Emergency Use Authorization (EUA) from the FDA for its HIV treatment leronlimab for the treatment of mild-to-moderate COVID-19 patients. Read More
Sinopharm’s COVID-19 vaccine generated antibodies at levels on par with some of its competitors, according to early trial data released by scientists connected with the company and other China-based research institutes. Read More
A potential COVID-19 treatment that uses mesenchymal stem cells (MSCs) has flown under the radar thus far, but the therapy has shown promise in early research, and phase 2/3 results that will likely come out in early fall could show that it’s a game changer. Read More
The FDA has finally put muscle behind its authority to fine flouters of the ClinicalTrials.gov reporting requirements, issuing a final guidance last week that confirms penalties of up to $10,000 per violation. Read More
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is developing a weakened strain of SARS-CoV-2 for use in human challenge trials in case they’re needed to fully evaluate COVID-19 vaccine and therapeutic candidates, though the institute says the controversial studies would not replace phase 3 trials. Read More
The U.S. government has chosen distribution giant McKesson as a “central distributor” of COVID-19 vaccines and supplies needed to administer them once an approval or emergency authorization is granted. Read More
The EU’s orphan drug regulations are not adequately supporting the development of medicines for rare diseases, according to a new report conducted on behalf of the European Commission. Read More