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UK medicines regulator gives approval for first UK COVID-19 vaccine

The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data, starting in October 2020. This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, ...
- Source: drugdu
- 373
- December 3, 2020
Covid-19 vaccine
Closing In On The Cause Of Alzheimer’s Disease

The unpredictability of Alzheimer’s disease may be partly caused by changes in star-shaped cells in the brain called astrocytes, find scientists from South Korea. AsianScientist (Dec. 1, 2020) – Despite decades of scientific research, Alzheimer’s disease and its causes still largely remain a mystery. Now, scientists from South Korea have identified a key indicator associated with neurodegeneration in Alzheimer’s. Their findings was published in Nature Neuroscience. Poignantly depicted in Hollywood films like The Notebook and Still Alice, Alzheimer’s disease is a brain disorder that accounts for a majority of cases of dementia, the progressive loss of memory and other cognitive abilities. Over the years, numerous hypotheses regarding the cause of Alzheimer’s have been presented. Perhaps the most prominent is the amyloid hypothesis, which pins the progression of Alzheimer’s on the build-up of beta-amyloid (Aβ) plaques in the brain. These plaques block cell signalling—potentially triggering inflammation and leading to brain cell ...
- Source: drugdu
- 391
- December 2, 2020
Alzheimer's disease
Moderna’s Phase 3 COVE study for its COVID-19 vaccine

30 November 2020 The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted. The final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis. Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has ...
- Source: drugdu
- 155
- December 1, 2020
Covid-19 vaccine
Data Byte

A COMPARISON OF NEUTRALIZATION TITERS AND PROTECTION DATA ACROSS CANDIDATES AND AGE GROUPS BY SELINA KOCH, EXECUTIVE EDITOR NOV 20, 2020 | 10:34 AM CST UPDATED ON NOV 20, 2020 AT 11:03 AM CST A pressing question about COVID-19 vaccines is how well they will perform in the elderly, who are at higher risk for severe disease. Wednesday’s report of strong efficacy in subjects over 65 given Pfizer and BioNTech’s mRNA vaccine could portend good news for several of the next candidates. In early-stage clinical trials, at least four other vaccines produced neutralizing antibody levels in non-elderly adults that were in line with those of BNT162b2 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), and for the most part, the vaccines’ titers fell less with age than BNT162b2. Only Ad5-nCoV from CanSino Biologics Inc. (HKEX:6185; Shanghai:688185) produced somewhat lower neutralization titers that fell farther with age than BNT162b2 in a live virus assay. Moderna Inc. ...
- Source: drugdu
- 355
- November 27, 2020
Covid-19 vaccine
How do Coronavirus Antibody Tests Work?

The coronavirus antibody test is performed to determine the blood level of antibodies that are developed against the virus. This test determines if a person was infected by a coronavirus in the past. Image Credit: joel bubble ben/Shutterstock.com What is coronavirus? Coronaviruses are a group of viruses that cause respiratory infections in humans. The infections can range from mild (common cold) to severe (Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS)). Importantly, coronavirus disease 2019 (COVID-19) is a severe, highly infectious disease caused by very recently identified coronavirus namely severe acute respiratory syndrome coronavirus 2 (SARS-CoV 2). How coronavirus is detected in COVID-19 patients? Presently, two types of viral tests are approved by the U.S Food and Drug Administration (FDA): molecular test and antigen test. In molecular tests, the viral genetic material is detected using polymerase chain reaction (PCR). The test is done using biological fluid collected from ...
- Source: drugdu
- 166
- November 25, 2020
Covid-19
Gaps remain in immunization logistics and real-time tracking of vaccine storage and demand

How prepared is the existing global cold chain, and especially refrigerated transport, to cope with the full temperature ranges required for the multiple COVID-19 vaccine candidates? A cold chain expert responds. “Overall, securing an end-to-end unbroken cold chain – from vaccine manufacturer to the site of injection, is an extremely hard thing to do. It requires constant monitoring and remedial action. “Why? The constituent parts of the cold chain are vastly distinct. They are separately operated but uniformly coordinated systems within an overall vaccine supply chain,” said Raja Rao, director, cold chain strategy and markets, B Medical Systems. Storage Vaccine distribution is complexity at its finest, he said. “It is almost always the case that the cold chain is relatively strongest between the site of manufacture and arrival at the port of entry, from Belgium to Nairobi, for example. This is because vaccines are air-shipped in modern, cold storage containers, ...
- Source: drugdu
- 235
- November 24, 2020
Covid-19 vaccine
‘We will be ready to distribute within hours of authorization’

The companies announced the conclusion of the vaccine’s Phase 3 trial earlier this week: reporting 95% efficacy. They also announced that they had gathered the two months of safety data required by the US’ Food and Drug Administration (FDA) for a Emergency Use Authorization (EUA) submission. Dr. Albert Bourla, Pfizer Chairman and CEO, said: “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.” Other regulatory submissions will follow ‘immediately’ Pfizer and BioNTech have already started rolling reviews of the ...
- Source: drugdu
- 396
- November 23, 2020
Covid-19 vaccine
Gaps remain in immunization logistics and real-time tracking of vaccine storage and demand

How prepared is the existing global cold chain, and especially refrigerated transport, to cope with the full temperature ranges required for the multiple COVID-19 vaccine candidates? A cold chain expert responds. “Overall, securing an end-to-end unbroken cold chain – from vaccine manufacturer to the site of injection, is an extremely hard thing to do. It requires constant monitoring and remedial action. “Why? The constituent parts of the cold chain are vastly distinct. They are separately operated but uniformly coordinated systems within an overall vaccine supply chain,” said Raja Rao, director, cold chain strategy and markets, B Medical Systems. Storage Vaccine distribution is complexity at its finest, he said. “It is almost always the case that the cold chain is relatively strongest between the site of manufacture and arrival at the port of entry, from Belgium to Nairobi, for example. This is because vaccines are air-shipped in modern, cold storage containers, ...
- Source: drugdu
- 320
- November 22, 2020
Covid-19 vaccine
FDA authorises first home self-testing kit for COVID-19

RELATED TAGS: Lucira Health, Us, emergency use authorization, COVID-19 The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Lucira COVID-19 All-In-One Test Kit: the first COVID-19 diagnostic test for self-testing at home. Lucira says the kit takes around two minutes to use; and gives rapid results within 30 minutes. The $50 kit – which fits in the palm of the hand – provides a simple ‘positive’ or ‘negative’ reading. The kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. It is authorized for prescription home use with self-collected nasal swab samples in people aged 14+ who are suspected of having COVID-19 by a healthcare provider. “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at ...
- Source: drugdu
- 340
- November 21, 2020
Covid-19
China’s Sinovac reports mixed findings in early coronavirus vaccine trials

A man works in a laboratory of Sinovac Biotech in Beijing on Sept. 24. The Chinese company is developing an experimental coronavirus vaccine. (Thomas Peter/Reuters) By Eva Dou November 18, 2020 at 5:09 p.m. GMT+8 Sinovac Biotech, one of China’s coronavirus vaccine front-runners, published mixed findings from its two first clinical trials Tuesday, raising the stakes in Indonesia, which has already declared plans to roll out Sinovac’s vaccine. While the vaccine appeared to be safe in these early clinical trials, the company reported that it generated lower levels of protective antibodies in the bloodstream compared with those arising in recovered coronavirus patients. In comparison, Moderna and Pfizer, which have separate experimental vaccines, had reported antibody levels on par with or higher than those produced in recovered coronavirus patients. These early results put Sinovac on the back foot to prove its vaccine is effective in ongoing Phase 3 trials. “That is a concern,” ...
- Source: drugdu
- 143
- November 19, 2020
Covid-19

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