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Johnson and Johnson today announced that it will accelerate the launch of its Phase 1/2a human clinical trial of a new crown recombinant vaccine Ad26.COV2-S, through its Janssen companyClinical trials, originally scheduled to begin in September, are now expected to begin in the second half of Julythis randomized double-blind, placebo-controlled phase 1/2a study will evaluate the safety, reactive (response) and immunogenicity of the research new coronary recombinant vaccine Ad26.COV2-SThe program is to recruit 1,045 healthy adults between the ages of 18 and 55, as well as adults over 65The study will be conducted in the United States and BelgiumThe vaccine was developed on Johnson and Johnson's Ad26 adenovirus vector technology platformThe company has developed vaccines against HIV, respiratory syncytial virus, and Ebola virus based on this technology platformthe company is in discussions with the National Institute of Allergy and Infectious Diseases (NIAID) to launch Phase 3 clinical trials ahead of schedule if the results are positive and approved by regulators"Based on the preclinical data we have so far and our interactions with regulators, we are able to further accelerate the clinical development of the research-based new crown vaccine," said DrPaul Stoffels, chief scientific officer atJohnson and JohnsonAt the same time, we are continuing our efforts to build important global partnerships and invest in our vaccine production technologies and manufacturing capabilitiesOur goal is to ensure that vaccines are available globally to protect people around the world from the pandemic"
Illumina's new NGS-based virus testing is authorized by the FDA for emergency use
Today, Illumina Announced that the U.SFDA has granted the company's COVIDSeq Testing Emergency Use Authorization (EUA)This is a high-throughput, new coronavirus in vitro diagnostic (IVD) workflow based on next-generation sequencing technology (NGS)The press release noted that this is the first new NGS-based diagnostic test to be authorized by the FDA for emergency useCOVIDSeq uses upper respiratory tract samples, including nasopharyngeal swabs or mouth swabs, and the NovaSeq 6000 sequencing system, which can obtain results within 24 hours of receiving the sampleThis diagnostic test includes 98 amplifiers targeting the entire genome of the new coronavirus, with a high degree of accuracy and sensitivity"COVIDSeq leverages the performance of NGS to help address the global demand for diagnostic testing to counter the COVID-19 pandemic," said MrFrancis de Souza, CEO of Illumina"In addition to developing diagnostic tests, Illumina and many of our customers are exploring NGS-based workflows for high-throughput screening and support for return to work and school"
NGS-based new coronavirus detection method scants not only for the diagnosis and screening of new coronavirus infections, but also because it can read the genome sequence of the new coronavirus, it may provide valuable information in monitoring the evolution of the new coronavirus by detecting genetic variation in the new coronavirusOriginal Title: COVID-19 Development: Johnson and Johnson's New Crown Vaccine will be tested in humans ahead of schedule, and the first NGS-based new crown test will be approved by the FDA for emergency use