Search Results for “ Pfizer” – Page 36 – media

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
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
- 360
- November 27, 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
- 238
- November 24, 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
- 324
- November 22, 2020
Covid-19 vaccine
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
- 145
- November 19, 2020
Covid-19
Moderna expects to know by the end of the month whether its Covid-19 vaccine works

By Elizabeth Cohen and Lauren Mascarenhas, CNN Updated 0510 GMT (1310 HKT) November 12, 2020 Fauci says vaccine could be available to all by April 02:52 (CNN)Moderna has finished accumulating data for a first analysis of its Covid-19 vaccine and expects to have an announcement on the vaccine’s efficacy by the end of the month, the company said in a statement Wednesday. Pfizer announced Monday that its coronavirus vaccine is more than 90% effective. Moderna is conducting a clinical trial of 30,000 participants, with half receiving the vaccine and half receiving a placebo, which is a shot of saline that does nothing. In order for Moderna’s vaccine to be considered for authorization by the US Food and Drug Administration, at least 53 study participants needed to become ill with Covid-19. The trial hit that 53 mark Wednesday, but Moderna doesn’t know if the participants who became ill received the vaccine or the ...
- Source: drugdu
- 348
- November 17, 2020
Covid-19
Anvisa suspende temporariamente teste da vacina CoronaVac, que será produzida pelo Butantan

Interrupção foi determinada após ‘evento adverso grave’, segundo a agência. Em entrevista à TV Cultura, diretor do Butantan disse que a morte do voluntário não teve relação com o teste. A Agência Nacional de Vigilância Sanitária (Anvisa) suspendeu temporariamente os testes em humanos da vacina CoronaVac contra a Covid-19. De acordo com a agência, a interrupção foi determinada nesta segunda-feira (9) por causa de um “evento adverso grave”, mas não deu detalhes sobre a causa específica da suspensão. A Anvisa informou que foi notificada do “evento” em 29 de outubro. Mais de 10 dias depois, determinou que nenhum novo voluntário poderá ser vacinado até que a agência possa avaliar os dados e “julgar o risco/benefício da continuidade do estudo”. Segundo uma lista divulgada pela agência, são considerados eventos adversos graves “morte, evento adverso potencialmente fatal, incapacidade ou invalidez persistente, internação hospitalar do paciente, anomalia congênita ou defeito de nascimento, qualquer suspeita de transmissão ...
- Source: drugdu
- 397
- November 11, 2020
Covid-19 vaccine
Argentina agrees to buy 25 million doses of Russia’s Covid-19 vaccine

President Fernández reveals in interview with Russian news agency that government will receive initial 10 million doses of Sputnik V vaccine by as early as December, should it clear clinical trials. resident Alberto Fernández said Monday that Argentina has accepted a proposal from Russia to buy an initial 10 million doses of its experimental Covid-19 vaccine, with delivery expected before the end of the year. The vaccine, which is given in two parts, could even arrive as early as next month provided clinical trials are successful, the president said in an interview with a Russian news agency. If successful, another 15 million doses could arrive in January, he added. The news comes just days after Perfil journalist Rosario Ayerdi revealed that Health Access Secretary Carla Vizzotti had travelled to Russia on October 17 on a fact-finding mission to learn more about the Russian vaccine, known as Sputnik V. Fernández confirmed Vizzotti’s ...
- Source: drugdu
- 298
- November 5, 2020
Covid-19 vaccine
Bayer to acquire Asklepios Bio in foray into gene therapy worth up to $4 billion

By Ludwig Burger FRANKFURT (Reuters) – Bayer <BAYGn.DE> agreed to acquire unlisted U.S. biotech firm Asklepios BioPharmaceutical Inc for as much as $4 billion in a bet on gene therapy with the help of modified viruses. Germany’s Bayer will pay $2 billion upfront and up to an additional $2 billion in milestone payments contingent on development achievements, it said on Monday. The North Carolina-based takeover target, also known as AskBio, is trying to use the harmless adeno-associated virus as a delivery device to bring genetic repair kits against a range of diseases into the body.Drugs and farming pesticides maker Bayer needs to upgrade its drug development pipeline amid a weaker outlook for agricultural sales and as it seeks to finalise an $11 billion settlement over claims its Roundup weedkiller causes cancer. Among AskBio’s most advanced projects are early tests on volunteers of prospective treatments against Pompe disease – a ...
- Source: drugdu
- 283
- November 2, 2020
Gene therapy

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