WHO warns regulators to consider all available evidence before approving remdesivir for COVID-19
October 26, 2020Sales and Marketing COVID, COVID-19, Gilead, coronavirus
The World Health Organization’s Chief Scientist Soumya Swaminathan has warned that experts and regulators assessing the use of Gilead’s remdesivir …
Patient Experience: Living with Timothy syndrome
October 26, 2020Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Timoty syndrome, feature, patient experience, rare disease
Thirteen-year-old Calvin Muir lives with the ultra-rare genetic condition Timothy syndrome. Like many parents of rare disease patients, his mother …
IBM and Pfizer designing AI model to predict onset of neurological diseases
October 23, 2020Medical Communications
IBM has partnered with Pfizer to design an artificial intelligence model to predict the eventual onset of neurological diseases – …
FDA approves Gilead’s remdesivir for hospitalised COVID-19 patients
October 23, 2020Medical Communications, Sales and Marketing COVID-19, FDA, Gilead, remdesivir
The FDA has approved Gilead’s antiviral therapy Veklury (remdesivir) for the treatment of hospitalised COVID-19 patients, making it the first …
Bayer’s Nubeqa secures NICE recommendation for hormone-relapsed prostate cancer at risk of metastasis
October 23, 2020Medical Communications, Sales and Marketing Bayer, NCIE, Nubeqa, pharma
NICE has given its recommendation to Bayer’s androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) for …
Three Ways to Speed Your GxP Validation without Risk
October 23, 2020Medical Communications, Research and Development
Computer system validation can often take months to complete. It typically involves infrastructure qualification (IQ), operational qualification (OQ), and performance …
Top Ten most popular articles on Pharmafile.com this week
October 23, 2020Medical Communications
The top ten news stories this week focus on coronavirus research, with the UK is set to be the first …
NICE recommends MSD’s Keytruda for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma
October 22, 2020Sales and Marketing MSD, NCIE, NHS, keytruda
NICE has moved to recommend the use of MSD’s blockbuster immunotherapy drug Keytruda (pembrolizumab) as a monotherapy in the treatment …
Gilead’s Biktarvy proves non-inferior to standard care for HIV in Black and African American patients
October 22, 2020Research 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 …
The European Medicines Agency recommends 10 medicines for approval in October meeting
October 22, 2020Research and Development
The EMA has recommended marketing authorisation for ten medicines and has also suggested ten label extensions. The agency’s Committee for …
Patient dies on AstraZeneca COVID-19 vaccine trial, but didn’t receive vaccine dose
October 22, 2020Research and Development
The University of Oxford and AstraZeneca say they will continue their coronavirus vaccine clinical trials after a volunteer had died …
Purdue Pharma pleads guilty to opioid charges in $8bn settlement with US Department of Justice
October 22, 2020Research and Development
Purdue Pharma has pleaded guilty to criminal charges filed due to its role in America’s opioid crisis and will pay …
Spain secures 31.6 million doses of AstraZeneca’s COVID-19 vaccine
October 21, 2020Manufacturing 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 …
Eli Lilly refutes FDA quality concerns at New Jersey facility producing COVID-19 drug
October 21, 2020Manufacturing 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 …
Brain imaging biomarker could predict how psychiatric disorder patients respond to treatment
October 21, 2020Research and Development MDMA, PTSD
A recent study has indicated that a newly identified brain imaging biomarker could help match patients with psychiatric disorders with …
UK set to be first country to expose healthy people to COVID-19 in studies
October 21, 2020Research and Development
The UK is set to be the first country to conduct challenge trials which will see healthy volunteers intentionally exposed …
Pharmafile.com’s weekly COVID-19 news round-up
October 21, 2020Research 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 …
New technology allows scientists to study the inside of cells using VR
October 20, 2020Manufacturing 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 …
New treatment could extend survival in amyotrophic lateral sclerosis patients
October 20, 2020Manufacturing 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 …
FDA grants priority review to AstraZeneca’s Tagrisso as an adjuvant for early-stage EGFR-mutated non-small cell lung cancer
October 20, 2020Manufacturing and Production, Sales and Marketing AstraZeneca, FDA, Tagrisso
The FDA has revealed its decision to grant Priority Review to AstraZeneca’s Tagrisso (osimertinib) as an adjuvant treatment of patients …
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