Infectious disease
Pennsylvania-based Inovio said the regulatory agency has additional questions about the Phase II/III trial regarding the vaccine candidate itself, known as INO-4800, as well as the company’s Cellectra 2000 delivery device.
The company posted an interim analysis of its Phase I/IIa trial that showed a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants and was well-tolerated.
Even when a first vaccine is finally approved, much of the developing world currently stands to be left behind, as it was during the 2009 H1N1 pandemic.
Endo International’s subsidiary, Par Sterile Products, LLC, has agreed to provide fill-finish manufacturing services to Novavax for commercial distribution of the vaccine company’s nanoparticle COVID-19 vaccine candidate.
New York’s governor hinted he would delay distribution of a quickly approved vaccine until its safety and efficacy could be vetted by a panel of state scientists and researchers.
The late-stage study is part of an agreement struck between the company and the U.K. government last month that includes providing 60 million doses of the vaccine, should it be approved.
First-generation therapeutics have been largely ineffective against the SARS-CoV-2 virus, resulting in significant challenges and opportunities for the second-generation therapeutics that are being designed now.
Infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during pregnancy does not appear to increase the risk of complications during delivery or negatively impact the health of newborns, according to a new JAMA study.
The move was announced due to the advisor’s role in overseeing a clinical study for Moderna’s mRNA vaccine candidate.
Lumen Bioscience was awarded a $4 million grant by the U.S. Army Medical Research and Development Command to develop a rapid, scalable and inexpensive biologic drug cocktail to treat gastrointestinal infection in COVID-19 patients.
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