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NICE knocks back Novartis’ Mayzent in secondary progressive multiple sclerosis over data gaps

June 25, 2020
Sales and Marketing Mayzent, NHS, NICE, Novartis

Novartis’ Mayzent (siponimod) has been unsuccessful in securing a recommendation from NICE for use on the NHS for the treatment …

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New research highlights how biases play a role in FDA drug approvals

June 25, 2020
Business Services FDA, FDA Approval

A new study has highlighted how human biases affect the regulatory approval process of the FDA.

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antibody_tests

COVID-19 antibody tests are being used by the NHS without proper assessment, experts warn

June 25, 2020
Business 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, …

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fauci

NIH ordered to cancel coronavirus research funding by White House, Dr Fauci tells Congress

June 25, 2020
Business 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 …

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Gilead acquires 49.9% of Pionyer Therapeutics in potential $1.5bn+ deal

June 24, 2020
Research 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 …

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UK health leaders urge “rapid review” of COVID-19 preparedness as England relaxes lockdown

June 24, 2020
Research 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 …

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Pharmafile.com’s weekly COVID-19 news round-up

June 24, 2020
Research 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 …

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Johnson & Johnson loses bid to overturn baby powder cancer case

June 24, 2020
Research 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 …

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home_office

UK Home office reclassifies Epidyolex as a Schedule 5 drug

June 24, 2020
Research 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 …

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Boehringer withdraws its £700m investment in Hikma Pharmaceuticals

June 23, 2020
Manufacturing 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 …

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saney

MHRA extends Santhera’s Puldysa on the Early Access to Medicines Scheme

June 23, 2020
Manufacturing and Production

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended Santhera’s Duchenne muscular dystrophy (DMD) drug Puldysa (idebone) for …

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vaccinesss_1

Sanofi expects approval for its COVID-19 vaccine by the start of 2021

June 23, 2020
Manufacturing 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 …

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gilead-sciences

Gilead to investigate inhaled formulation of promising COVID-19 therapy remdesivir

June 23, 2020
Manufacturing 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 …

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fda

FDA and EMA agree to intensify collaboration during COVID-19 pandemic

June 23, 2020
Manufacturing 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 …

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How is COVID-19 impacting the rare disease community?

June 22, 2020
Business 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 …

Feature
sanofi

Sanofi’s Dupixent scores Chinese approval in moderate to severe atopic dermatitis

June 22, 2020
Sales 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 …

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New UK consortium established to monitor COVID-19 vaccine efficacy once they hit market

June 22, 2020
Manufacturing 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 …

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lockdown_uk

SAGE group warns it is not safe to relax social distancing rules across Britain

June 22, 2020
Sales 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 …

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NIH halts hydroxychloroquine trial after no benefit found in COVID-19 patients

June 22, 2020
Sales 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 …

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Germany’s infection rate rapidly rises as world sees its largest daily increase in COVID-19 cases

June 22, 2020
Sales 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. …

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