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LATEST PUBLICATIONS



FDA ad police’s warning letters have stalled during COVID-19, and that’s likely the new norm: expert

August 5, 2020

Category: FDA, News, Regulations

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 […]


Merck to Move COVID-19 Vaccine Candidate into Phase I in Q3

July 31, 2020

Category: Industry, Vaccines

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 […]


FDA rails at California CDMO for failing to secure data used to determine strength of its drugs

July 22, 2020

Category: FDA, Regulations

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 […]


FDA, Regulations

FDA Accepts Biogen’s BLA for Alzheimer’s Candidate Aducanumab

August 10, 2020

Via: Genetic Engineering and Biotechnology News

Biogen (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

COVID-19 Patients Exhibit Early Antibody Signatures Potentially Predictive of Death or Recovery

August 10, 2020

Via: Genetic Engineering and Biotechnology News

Researchers 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, […]


FDA, Regulations

FDA Accepts BLA for Biogen’s Alzheimer’s Drug, Grants Priority Review

August 7, 2020

Via: BioSpace

Shares 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

Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19…

August 7, 2020

Via: Pharma IQ

As 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

Gut Microbiome Influences B Cell and Antibody Repertoire

August 6, 2020

Via: Genetic Engineering and Biotechnology News

The 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

Epigenetic Regulation Key to Daily Formation of Billions of Blood Cells

August 6, 2020

Via: Genetic Engineering and Biotechnology News

Just 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 […]