Archives: 2021-01-12

PIER MARIA FORNASARI
2021-01-12

EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca. Marketing authorisation could be issued by 29 January

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines (CHMP), provided

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PIER MARIA FORNASARI
2021-01-11

A CDC study published on JAMA shows that People without symptoms spread SARS-CoV-2 in more than half of cases.

A model developed by CDC researchers estimates that 59% of coronavirus cases in the United States are spread by asymptomatic carriers. Transmissions from individuals who have not yet begun to exhibit signs of infection account for 35% of that total, while transmissions from people who never develop symptoms make up the other 24%. A model

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PIER MARIA FORNASARI
2021-01-11

Regulatory perspectives of Exosomes as therapeutics and drug delivery vehicles

Exosomes are nano-sized extracellular vesicles secreted by all cells. Extensive research over recent years has now shown these vesicles to be important players in intercellular signalling and to have a role in tissue regeneration, immunomodulation and other biological functions. A lipid bilayer protects the exosome cargo of nucleic acids and proteins from degradation and permits

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PIER MARIA FORNASARI
2021-01-11

Study finds higher burden of acute brain dysfunction for COVID-19 ICU patients

COVID-19 patients admitted to intensive care in the early months of the pandemic were subject to a significantly higher burden of delirium and coma than is typically found in patients with acute respiratory failure. Choice of sedative medications and curbs on family visitation played a role in increasing acute brain dysfunction for these patients. That’s

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PIER MARIA FORNASARI
2021-01-11

For U.K. health officials, Interleukin-6 inhibitors (Tocilizumab or Sarilumab) should be prescribed to adult patients admitted to ICU with Covid-19 pneumonia.

Clinicians should consider prescribing intravenous tocilizumab following the criteria defined below for patients in intensive care. Intravenous sarilumab could be considered as an alternative (if available).Any provider organisation treating patients with this intervention will be required to assure itself that the internal governance arrangements have been completed before either medicine is prescribed. These arrangements may

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PIER MARIA FORNASARI
2021-01-11

An In Vitro Study Shows Pfizer-Biontech COVID-19 Vaccine Elicits Neutralizing Antibodies against SARS-COV-2 with N501Y Mutation

 Pfizer Inc. and BioNTech SE  announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB) that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. The results were published

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PIER MARIA FORNASARI
2021-01-08

FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff

Impact on molecular tests remains low The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results

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