Research and Development

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Three Ways to Speed Your GxP Validation without Risk

October 23, 2020 Medical Communications, Research and Development

Computer system validation can often take months to complete. It typically involves infrastructure qualification (IQ), operational qualification (OQ), and performance …
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Gilead’s Biktarvy proves non-inferior to standard care for HIV in Black and African American patients

October 22, 2020 Research and Development Biktarvy, Gilead, HIV, pharma

Gilead has revealed promising new Phase 3 data reinforcing the non-inferiority of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg) compared to …
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The European Medicines Agency recommends 10 medicines for approval in October meeting

October 22, 2020 Research and Development

The EMA has recommended marketing authorisation for ten medicines and has also suggested ten label extensions.  The agency’s Committee for …
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Patient dies on AstraZeneca COVID-19 vaccine trial, but didn’t receive vaccine dose

October 22, 2020 Research and Development

The University of Oxford and AstraZeneca say they will continue their coronavirus vaccine clinical trials after a volunteer had died …
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Purdue Pharma pleads guilty to opioid charges in $8bn settlement with US Department of Justice

October 22, 2020 Research and Development

Purdue Pharma has pleaded guilty to criminal charges filed due to its role in America’s opioid crisis and will pay …
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Spain secures 31.6 million doses of AstraZeneca’s COVID-19 vaccine

October 21, 2020 Manufacturing and Production, Research and Development AstraZeneca, COVID-19, Spain, Vaccine

AstraZeneca continues to forge agreements with national governments to deliver its vaccine against COVID-19, with Spain becoming the latest country …
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Eli Lilly refutes FDA quality concerns at New Jersey facility producing COVID-19 drug

October 21, 2020 Manufacturing and Production, Research and Development COVID-19, Eli Lilly, FDA, pharma

Eli Lilly has rebutted reports of FDA quality assurance concerns at its manufacturing facility in Branchburg, New Jersey, where it …
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Brain imaging biomarker could predict how psychiatric disorder patients respond to treatment

October 21, 2020 Research and Development MDMA, PTSD

A recent study has indicated that a newly identified brain imaging biomarker could help match patients with psychiatric disorders with …
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UK set to be first country to expose healthy people to COVID-19 in studies

October 21, 2020 Research and Development

The UK is set to be the first country to conduct challenge trials which will see healthy volunteers intentionally exposed …
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Pharmafile.com’s weekly COVID-19 news round-up

October 21, 2020 Research and Development COVID-19, coronavirus

The coronavirus news this week focuses on COVID-19 treatments, with Gilead’s remdesivir being found to have no impact on mortality …
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New technology allows scientists to study the inside of cells using VR

October 20, 2020 Manufacturing and Production, Research and Development VR, Virtual reality, pharma

New virtual reality software allows researchers to “walk” inside cells and analyse them up close in order to better understand …
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New treatment could extend survival in amyotrophic lateral sclerosis patients

October 20, 2020 Manufacturing and Production, Research and Development als, pharma

Research into an experimental drug combination shows that it could potentially extend the lives for sufferers of amyotrophic lateral sclerosis …
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Gilead’s remdesivir and three other repurposed drugs have no impact on COVID-19 mortality, WHO study finds

October 16, 2020 Medical Communications, Research and Development COVID-19, pharma, remdesivir

Gilead’s antiviral therapy remdesivir has emerged as one of the most promising drugs to treat COVID-19 infections, but recent studies …
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80 researchers argue COVID-19 herd immunity strategy is a “dangerous fallacy” in open letter

October 15, 2020 Medical Communications, Research and Development, Sales and Marketing COVID-19

A group of 80 researchers have lent their signatures to an open letter published in the The Lancet under the …
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FDA approves Regeneron’s antibody Ebola treatment

October 15, 2020 Research and Development Ebola, ebola antibody., ebola treatment

The FDA has approved Regeneron’s antibody drug inmazeb for treating Ebola. The treatment works through targeting the glycoprotein on the …
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