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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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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 …

News
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FDA grants priority review to AstraZeneca’s Tagrisso as an adjuvant for early-stage EGFR-mutated non-small cell lung cancer

October 20, 2020
Manufacturing 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 …

News
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EMA’s CHMP recommends conditional approval for Kite Pharma’s CAR T therapy for mantle cell lymphoma

October 20, 2020
Manufacturing and Production, Sales and Marketing CAR T, CAR-T, CHMP, EMA, kite pharma, lymphoma

Kite Pharma’s anti-CD19 chimeric antigen receptor (CAR) T cell therapy known as KTE-X19 has received positive recommendation from the EMA’s …

News
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European Commission stands by €1bn remdesivir supply deal despite disappointing COVID-19 benefit

October 19, 2020
Manufacturing and Production, Sales and Marketing COVID-19, Europe, Gilead, remdesivir

As Europe continues to face down a rising second wave of COVID-19, the European Commission quickly moved to secure a …

News

Pfizer won’t apply for COVID-19 vaccine emergency authorisation until after US election, CEO says

October 19, 2020
Sales and Marketing COVID-19, Pfizer, US, Vaccine

The Chief Executive Officer of Pfizer has said that the company will now submit their vaccine for FDA Emergency Use …

News
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UK life sciences industry does not want no-deal Brexit, says ABPI Chief

October 19, 2020
Sales and Marketing ABPI, EU, UK, brexit, pharma

Prime Minister Boris Johnson’s sudden change of position that the UK is now expecting a no-deal scenario with the European …

News
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Sanofi’s Dupixent chalks up CHMP recommendation for paediatric severe atopic dermatitis

October 19, 2020
Sales and Marketing Dupixent, EMA, Sanofi, atopic dermatitis

Sanofi’s interleukin-4 and -13 inhibitor Dupixent (dupilumab) has been given the recommendation of the European Medicines Agency’s Committee for Medicinal …

News
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CHMP recommendation for Janssen’s Tremfya in active psoriatic arthritis

October 19, 2020
Sales and Marketing CHMP, EMA, Janssen, Tremfya

Janssen’s interleukin (IL)-23 inhibitor Tremfya (guselkumab) has scored a recommendation from the EMA’s Committee for Medicinal Products for Human Use …

News

FDA approves Venclexta combo in acute myeloid leukaemia, despite it missing main study goal

October 19, 2020
Sales and Marketing AbbVie, FDA, Roche, Venclexta, pharma

The FDA has given approval to AbbVie and Roche’s jointly-developed BCL-2 inhibitor Venclexta (venetoclax) in combination with azacitidine, decitabine, or low-dose …

News
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NICE approves Sanofi’s Sarclisa combo for relapsed/refractory multiple myeloma

October 16, 2020
Medical Communications, Sales and Marketing NICE, Sanofi, Sarclisa, multiple myeloma

Sanofi’s Sarclisa (isatuximab) has secured a recommendation from NICE for routine use on the NHS in England and Wales as …

News
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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 …

News
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Five-year-old girl that was part of Lysogene’s gene therapy clinical trial dies

October 16, 2020
Medical Communications

A five-year-old girl had died while taking part in Lysogene’s clinical trial investigating its gene therapy. The child was suffering …

News
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