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The Editors’ views: European Pharmaceutical Review’s 2020 round-up
Junior Editors of European Pharmaceutical Review, Hannah Balfour and Victoria Rees, discuss some of the most noteworthy news and announcements from this year.
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Biologics
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Bioprocessing & Bioproduction In-Depth Focus 2020
In this in-depth focus learn about the development and implications of a novel high-throughput method for glycoanalytics and how taking a full-ecosystem approach to microbiome restoration could improve patient survival.
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Health Canada authorises emergency use of Pfizer’s COVID-19 vaccine
Canada becomes the third country to approve Pfizer and BioNTech’s mRNA COVID-19 vaccine BNT162b2 for emergency use - after UK and Bahrain.
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AZD1222 vaccine for COVID-19 is safe and effective in Phase III trials
Interim analysis shows AZD1222 vaccine is effective at preventing COVID-19, with no severe cases or hospitalisations reported more than 21 days after first injection.
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Fact sheet: 5 Secrets to a successful cleaning validation program
Here are five ways to ensure a successful and compliant cleaning validation program.
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Universal influenza vaccine shows promise in early-phase clinical trial
The chimeric hemagglutinin (HA)-based vaccine induced a strong, functional immune response that lasted at least 18 months.
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Supply chain challenges cause Pfizer’s COVID-19 vaccine production target to be slashed
Pfizer spokesperson reveals supply chain challenges and late clinical trial results contributed to its COVID-19 vaccine production target for 2020 being halved.
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Could newborn stem cells revolutionise cell therapies?
In this article, Dr Jaime Shamonki, Generate Life Science’s CMO, discusses how newborn stem cells derived from umbilical cord tissue could make mesenchymal stem cells less expensive and variable to produce.
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COVID-19 S-Trimer vaccine candidates show promise in early trials
When adjuvanted with GSK’s pandemic adjuvant system, the S-Trimer vaccine candidates induced the production of neutralising antibodies in all trial participants.
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Axi-cel highly effective in patients with advanced non-Hodgkin lymphoma, finds Phase II trial
Investigators report 76 percent of trial participants had a complete response to axicabtagene ciloleucel (axi-cel), despite being resistant to other therapies.
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First-in-human universal CAR-T therapy trial begins
The dose-finding trial will evaluate the safety and activity of UniCAR-T-PSMA in up to 16 patients with advanced relapsed/refractory, PSMA-positive solid tumours.
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Moderna applies for regulatory authorisation for COVID-19 vaccine
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
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WHO report suggests African countries are not ready for COVID-19 vaccines
The WHO Regional Director for Africa urges governments to “ramp up readiness” as report suggests the region is not prepared for a COVID-19 vaccine roll-out.
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COVAXX commits to deliver 140 million COVID-19 vaccine doses to emerging markets
The company suggests their experimental COVID-19 vaccine, UB-612, has the features and potential to disrupt the traditional vaccine distribution and supply status quo.
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One of the oldest vaccines could help combat COVID-19
Researchers have shown that recipients of the Bacillus Calmette-Guérin (BCG) vaccine are less likely to contract COVID-19 in a new study.
