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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
- 380
- 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
- 404
- 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
- 161
- December 1, 2020
Covid-19 vaccine
Novel cannabis plant extracts could protect against COVID-19

Researchers in Canada have conducted a study suggesting that novel Cannabis sativaextracts may decrease levels of the host cell receptor that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses to gain viral entry to target tissues. SARS-CoV-2 is the agent responsible for the current coronavirus disease 2019 (COVID-19) pandemic that continues to sweep the globe threatening public health and the worldwide economy. The team – from the University of Lethbridge and Pathway Rx Inc., Lethbridge – developed hundreds of new C. sativa cultivars and tested 23 extracts in artificial 3D human models of the oral, airway and intestinal tissues. As recently reported in the journal Aging, 13 of the extracts downregulated expression of the SARS-CoV-2 host cell receptor angiotensin-converting enzyme 2 (ACE2). “The observed down-regulation of ACE2 gene expression by several tested extracts of new C. sativa cultivars is a novel and crucial finding,” say the researchers. “While our most effective extracts require further large-scale validation, ...
- Source: drugdu
- 471
- November 30, 2020
Covid-19
Subscribe to our FREE newsletter Subscribe New EU pharma strategy looks to future-proof healthcare sector, stimulate innovation and boost access to biosimilars and generics

The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and rare diseases. It is also aiming to bolster the competitiveness and the innovative capacity of the EU’s pharma industry. Enhancing crisis preparedness and response mechanisms, and addressing security of supply, drawing lessons from the COVID-19 crisis, are also namechecked as top policy priorities in the strategy, as well as a need to guarantee a strong EU voice on the global stage by promoting a high level of quality, efficacy and safety standards. “The COVID-19 pandemic has, and continues to have, a very serious impact on Europe. Though Europe’s response has demonstrated strengths, existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines or the availability ...
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- 201
- November 29, 2020
pharma
BioNTech & InstaDeep launch AI innovation lab for next-generation vaccines and biopharmaceuticals

BioNTech and InstaDeep are creating a joint AI innovation lab in Europe to develop novel immunotherapies. “We see a significant opportunity at the intersection of AI and immunology by computational design of new precision immunotherapies,” says BioNTech. One of the key research areas will be the development of next generation vaccines and biopharmaceuticals – including for COVID-19 – as well as for the treatment of cancer and prevention and therapy of infectious diseases. The partnership between Mainz-headquarted BioNTech (which is collaborating with Pfizer on one of the leading mRNA-based COVID-19 vaccine candidates) and London-based InstaDeep will create a joint AI innovation lab between the two cities. The lab will advance a portfolio of initiatives across drug discovery and design, protein engineering, manufacturing and supply chain optimization. Founded in 2014, InstaDeep has already developed collaborations in the global AI ecosystem: such as Google DeepMind, Nvidia and Intel. It was nominated by CB ...
- Source: drugdu
- 418
- November 28, 2020
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
- 362
- November 27, 2020
Covid-19 vaccine
Study on the effect of miR-223 derived from macrophage exosomes on the metastasis of gastric cancer cells

Henan Provincial People’s Hospital Zheng Peiming, Gao Huijie, Li Junmeng, et al. select macrophages and their exosomes to co-culture with gastric cancer cells (not set as a control group) to detect the expression of miR-223 and observe its influence on the metastatic ability of gastric cancer cells. Fluorescence microscope was used to observe whether macrophages delivered miR-223 to gastric cancer cells through exosomes. Macrophages were transfected with miR-223 antagonist, exosomes were isolated and co-cultured with gastric cancer cells, transwell and scratch experiments were performed to observe their effects on gastric cancer cell metastasis, reverse transcription polymerase chain reaction (RT-PCR), Western blot detection on expression of protein tyrosine phosphatase (PTEN) and of transfer-related proteins. The results showed that after macrophages and their exosomes were co-cultured with gastric cancer cells, the metastasis and invasion ability of gastric cancer cells was enhanced [253.2±6.3 (control group), 451.8±12.8, 453.4±14.4, all P<0.01 compared with control group ...
- Source: drugdu
- 321
- November 26, 2020
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
- 175
- 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
- 240
- November 24, 2020
Covid-19 vaccine

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