Sanofi’s Dupixent shows strength at Phase 3 in eosinophilic esophagitis

October 27, 2020
Manufacturing and Production Dupixent, Sanofi, pharma

Sanofi has lifted the curtain on new Phase 3 data for Dupixent (dupilumab), showing that the drug met all of …

Eli Lilly antibody treatment fails COVID-19 study

October 27, 2020
Manufacturing and Production

The US Government is putting an early end to clinical trials testing Eli Lilly’s antibody drug in COVID-19 patients.  The …

New trial to test if cancer drug can effectively treat hallucinations in Parkinson’s patients

October 27, 2020
Manufacturing and Production Parkinson's, Parkinson's UK

A new study is set to go ahead that will test if ondansetron is safe and effective in treating Parkinson’s …

US could have avoided over 130,000 COVID-19 deaths, according to a new study

October 27, 2020
Manufacturing and Production COVID, COVID-19, Trump, coronavirus

New studies suggest that the US could have avoided over 130,000 deaths if it responded earlier and in a coordinated …

Bayer buys out US-based Asklepios BioPharmaceutical in potential $4bn deal

October 26, 2020
Sales and Marketing Asklepios, Bayer, acquisition, pharma

Bayer has moved to bolster its cell and gene therapy (CGT) business through the acquisition of US biotech Asklepios BioPharmaceutical …

AstraZeneca’s COVID-19 vaccine generates immune response in both old and young participants

October 26, 2020
Research and Development, Sales and Marketing AstraZeneca, COVID-19, University of Oxford, Vaccine

AstraZeneca’s much-hyped COVID-19 vaccine candidate, AZD1222, currently in development in partnership with the University of Oxford, has shown promising immune …

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 …

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 …

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 …

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 …

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 – …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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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