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Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for […]
Continue ReadingToday, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue removed from the body). The software, called Paige Prostate, is […]
Continue ReadingThe fast spread of the highly infectious Delta variant underscores the need for faster identification of COVID-19 mutations. Uniting governments and medical communities in this challenge, the University of Oxford and Oracle’s Global Pathogen Analysis System (GPAS) is now being used by organizations on nearly every continent. Institutions using the platform include: the University of […]
Continue ReadingRoche (SIX: RO, ROG; OTCQX: RHHBY) announced the introduction of the Roche Digital Pathology Open Environment that allows software developers to easily integrate their image analysis tools for tumour tissue with Roche’s uPath enterprise software, an application for pathologist workflow. This open environment allows for the secure exchange and flow of data so that pathologists […]
Continue ReadingBreathe in, breathe out. That’s how easy it is for SARS-CoV-2, the virus that causes COVID-19, to enter your nose. And though remarkable progress has been made in developing intramuscular vaccines against SARS-CoV- 2, such as the readily available Pfizer, Moderna and Johnson & Johnson vaccines, nothing yet – like a nasal vaccine – has […]
Continue ReadingToday, the U.S. Food and Drug Administration announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT). The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level. This reorganization will advance the agency’s […]
Continue ReadingUsing a virus that grows in black-eyed pea plants, nanoengineers at the University of California San Diego developed a new treatment that could keep metastatic cancers at bay from the lungs. The treatment not only slowed tumor growth in the lungs of mice with either metastatic breast cancer or melanoma, it also prevented or drastically […]
Continue ReadingAn expert review by an international group of scientists, including some at the WHO and FDA, concludes that, even for the delta variant, vaccine efficacy against severe COVID is so high that booster doses for the general population are not appropriate at this stage in the pandemic. The review, published in The Lancet, summarises the […]
Continue ReadingChronic lesions with inflamed rims, or “smoldering” plaques, in the brains of people with multiple sclerosis (MS) have been linked to more aggressive and disabling forms of the disease. Using brain tissue from humans, researchers at the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (NINDS) built a detailed cellular map of […]
Continue ReadingPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. The same data […]
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