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 …
EMA’s CHMP recommends conditional approval for Kite Pharma’s CAR T therapy for mantle cell lymphoma
October 20, 2020Manufacturing 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 …
European Commission stands by €1bn remdesivir supply deal despite disappointing COVID-19 benefit
October 19, 2020Manufacturing 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 …
Pfizer won’t apply for COVID-19 vaccine emergency authorisation until after US election, CEO says
October 19, 2020Sales 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 …
UK life sciences industry does not want no-deal Brexit, says ABPI Chief
October 19, 2020Sales 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 …
Sanofi’s Dupixent chalks up CHMP recommendation for paediatric severe atopic dermatitis
October 19, 2020Sales 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 …
CHMP recommendation for Janssen’s Tremfya in active psoriatic arthritis
October 19, 2020Sales 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 …
FDA approves Venclexta combo in acute myeloid leukaemia, despite it missing main study goal
October 19, 2020Sales 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 …
NICE approves Sanofi’s Sarclisa combo for relapsed/refractory multiple myeloma
October 16, 2020Medical 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 …
Gilead’s remdesivir and three other repurposed drugs have no impact on COVID-19 mortality, WHO study finds
October 16, 2020Medical 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 …
Five-year-old girl that was part of Lysogene’s gene therapy clinical trial dies
October 16, 2020Medical Communications
A five-year-old girl had died while taking part in Lysogene’s clinical trial investigating its gene therapy. The child was suffering …
‘Long COVID’ could be taking four different forms
October 16, 2020Medical Communications coronavirus, covid symptoms, long covid, symptoms
People experiencing chronic illnesses after COVID-19 infections could be suffering from one of four separate conditions, according to new research. …
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