August 12, 2020
August 10, 2020
August 5, 2020
August 13, 2020
August 12, 2020
August 5, 2020
Enforcement letter output from the FDA’s advertising watchdog has slowed to zero during the COVID-19 pandemic. Only one letter from Office of Prescription Drug Promotion (OPDP) has been sent in 2020, and that was back in February, before the pandemic […]
July 31, 2020
Merck is joining the ranks of pharmaceutical companies that have a COVID-19 vaccine candidate in clinical development. Merck will move its candidate into clinical trials in the third quarter of this year, the company announced this morning. The move to […]
July 22, 2020
Generally speaking, the quality of a manufacturer’s data is only as good as the policies in place to ensure the information. Allowing all employees to access those data files—and even possibly delete them—isn’t exactly a good policy, and the FDA […]
August 10, 2020
Genetic Engineering and Biotechnology NewsBiogen (BIIB) said its BLA for aducanumab, the Alzheimer’s disease candidate it is co-developing with Eisai, has been accepted for Priority Review by the FDA with a target action date of March 7, 2021—and a decision expected from the agency […]
Clinical Trials, Research and Development
August 10, 2020
Genetic Engineering and Biotechnology NewsResearchers at the Ragon Institute of MGH, MIT and Harvard, and the University of Washington (UW) School of Medicine, have identified five immune response markers that, collectively, were able to distinguish between those COVID-19 patients who convalesced from the infection, […]
August 7, 2020
BioSpaceShares of Biogen jumped more than 11% in premarket trading after the company announced the U.S. Food and Drug Administration accepted its Biologics License Application for aducanumab, an investigational treatment for Alzheimer’s disease. Not only did the regulatory agency accept […]
Clinical Trials, Industry, Pharma, Research and Development
August 7, 2020
Pharma IQAs the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. The governing […]
Biotech, Clinical Trials, Industry, Research and Development
August 6, 2020
Genetic Engineering and Biotechnology NewsThe influence that the gut microbiota has over the human body continues to expand in interesting ways. Seeing as the intestinal tract contains the largest concentration of immunological tissue (mucosa-associated lymphoid tissue or MALT) it seems logical that the microbial […]
Clinical Trials, Research and Development
August 6, 2020
Genetic Engineering and Biotechnology NewsJust one in 2,000 bone marrow cells is a hematopoietic stem cells (HSC), but these cells are the source of the ten billion blood cells that the human body makes every day. The results of research in mice by scientists […]
August 13, 2020
August 12, 2020
August 13, 2020
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