New research highlights how biases play a role in FDA drug approvals
June 25, 2020Business Services FDA, FDA Approval
A new study has highlighted how human biases affect the regulatory approval process of the FDA.
COVID-19 antibody tests are being used by the NHS without proper assessment, experts warn
June 25, 2020Business Services, Research and Development COVID-19, antibodies, antibody, coronavirus
Coronavirus antibody tests that are beginning to be used by NHS and care staff have been distributed without adequate assessment, …
NIH ordered to cancel coronavirus research funding by White House, Dr Fauci tells Congress
June 25, 2020Business Services COVID-19, Fauci, NIH, coronavirus, pandemic
The National Institutes of Health had its funding cut from a research project into bat coronavirus, according its Director Dr …
Gilead acquires 49.9% of Pionyer Therapeutics in potential $1.5bn+ deal
June 24, 2020Research and Development, Sales and Marketing Gilead, Pionyr, pharma
Gilead has announced its intention to acquire 49.9% of shares in cancer immunotherapy specialist Pionyr Therapeutics with a payment of …
UK health leaders urge “rapid review” of COVID-19 preparedness as England relaxes lockdown
June 24, 2020Research and Development COVID-19, England, UK, coronavirus
British Prime Minister Boris Johnson announced an extensive rollback of existing lockdown measures to restrict the spread of COVID-19 in …
Pharmafile.com’s weekly COVID-19 news round-up
June 24, 2020Research and Development COVID, COVID-19, coronavirus
Coronavirus news this week sees treatments for existing diseases being tested in COVID-19 patients, with Roche’s rheumatoid arthritis drug Actemra …
Johnson & Johnson loses bid to overturn baby powder cancer case
June 24, 2020Research and Development Johnson and Johnson, talc, talc powder
Johnson & Johnson have had a bid to overturn a verdict that blamed the company’s baby powder for giving women …
UK Home office reclassifies Epidyolex as a Schedule 5 drug
June 24, 2020Research and Development CBD, cannabiodiol, cannabis
The Home Office has announced that the drug Epidyolex (cannabidiol) has been reclassified as a Schedule 5 drug, a move …
Boehringer withdraws its £700m investment in Hikma Pharmaceuticals
June 23, 2020Manufacturing and Production, Sales and Marketing Boehringer, Hikma
Boehringer has revealed that it intends to withdraw its investment from Hikma Pharmaceuticals, with the company poised to sell 28 …
MHRA extends Santhera’s Puldysa on the Early Access to Medicines Scheme
June 23, 2020Manufacturing and Production
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended Santhera’s Duchenne muscular dystrophy (DMD) drug Puldysa (idebone) for …
Sanofi expects approval for its COVID-19 vaccine by the start of 2021
June 23, 2020Manufacturing and Production COVID-19, coronavirus
Sanofi has said it expects to have its coronavirus vaccine approved by the start of next year which is faster …
Gilead to investigate inhaled formulation of promising COVID-19 therapy remdesivir
June 23, 2020Manufacturing and Production, Research and Development COVID-19, Gilead, remdesivir
Gilead is intent on pushing the applications of its antiviral drug remdesivir after it has shown efficacy in the treatment …
FDA and EMA agree to intensify collaboration during COVID-19 pandemic
June 23, 2020Manufacturing and Production COVID-19, coronavirus
Senior officials from the US Food and Drug Administration and the European Medicines Agency have pledged to continue working closely …
How is COVID-19 impacting the rare disease community?
June 22, 2020Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, cambridge rare disease network, pharma, rare disease
The COVID-19 pandemic has altered the life of just about everyone, especially patients in receiving continued treatment and care. But …
Sanofi’s Dupixent scores Chinese approval in moderate to severe atopic dermatitis
June 22, 2020Sales and Marketing China, Dupixent, Sanofi, atopic dermatitis, pharma
China’s National Medical Products Administration (NMPA) has moved to approve a 300mg pre-filled pen formulation of Sanofi and Regeneron’s Dupixent …
New UK consortium established to monitor COVID-19 vaccine efficacy once they hit market
June 22, 2020Manufacturing and Production, Sales and Marketing COVID-19, DSRU, MEMO Research, Vaccine, coronavirus, pharma
The UK’s Drug Safety Research Unit (DSRU) and the University of Dundee’s Medicines Monitoring Unit (MEMO Research) have come together …
SAGE group warns it is not safe to relax social distancing rules across Britain
June 22, 2020Sales and Marketing COVID-19, coronavirus, pandemic
The Independent SAGE group has warned that it is not safe to relax social distancing rules for indoor settings, after …
NIH halts hydroxychloroquine trial after no benefit found in COVID-19 patients
June 22, 2020Sales and Marketing COVID-19, chloroquine, hydroxychloroquine, pandemic
The National Institutes of Health (NIH) have suspended clinical trials of hydroxychloroquine after the drug was found to have no …
Germany’s infection rate rapidly rises as world sees its largest daily increase in COVID-19 cases
June 22, 2020Sales and Marketing COVID-19, coronavirus, pandemic
Germany’s coronavirus R number has drastically increased while the world faced its largest increase in cases since the pandemic began. …
EU reportedly in talks with J&J to secure doses of its COVID-19 vaccine
June 19, 2020Medical Communications, Research and Development, Sales and Marketing COVID-19, EU, Europe, J&J, JJ, Vaccine
It has been reported that the European Union is currently negotiating a deal with pharma giant Johnson & Johnson to …
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