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Novartis announces positive Phase 2 data of rare renal disease therapy iptacopan

October 26, 2020
Sales and Marketing

Novartis has announced positive Phase 2 interim analysis results for iptacopan, which is an investigational oral treatment for rare renal …

News
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UK Government outlines steps to tackle growing misuse of fentanyl

October 26, 2020
Sales and Marketing

The British Government has responded to a report investigating the misuse of fentanyl and painkillers in the UK. In January …

News
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WHO warns regulators to consider all available evidence before approving remdesivir for COVID-19

October 26, 2020
Sales 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 …

News
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Patient Experience: Living with Timothy syndrome

October 26, 2020
Business 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 …

Feature
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IBM and Pfizer designing AI model to predict onset of neurological diseases

October 23, 2020
Medical Communications

IBM has partnered with Pfizer to design an artificial intelligence model to predict the eventual onset of neurological diseases – …

News
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FDA approves Gilead’s remdesivir for hospitalised COVID-19 patients

October 23, 2020
Medical 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 …

News
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Bayer’s Nubeqa secures NICE recommendation for hormone-relapsed prostate cancer at risk of metastasis

October 23, 2020
Medical 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 …

News
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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 …

News
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Top Ten most popular articles on Pharmafile.com this week

October 23, 2020
Medical Communications

The top ten news stories this week focus on coronavirus research, with the UK is set to be the first …

News
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NICE recommends MSD’s Keytruda for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma

October 22, 2020
Sales 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 …

News
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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 …

News
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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 …

News
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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 …

News
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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 …

News
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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 …

News
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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 …

News
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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 …

News
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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 …

News
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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 …

News
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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 …

News
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