Manufacturing and Production

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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 …
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 …
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 …
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 …
pexels-photo-3044623_araruna

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 …
800px-mantoux_tuberculin_skin_test_greg_knobloch

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 …

FDA approval for Jazz and PharmaMar’s Zepzelca in metastatic small cell lung cancer

June 17, 2020 Manufacturing and Production, Research and Development, Sales and Marketing Cancer, FDA, PharmaMar, Zepzelca, jazz pharma, lung cancer

The FDA has awarded approval to Jazz Pharma and PharmaMar for Zepzelca (lurbinectedin) as a treatment for metastatic small cell …
sanofi

Sanofi drops €610m on new vaccine research and manufacturing sites in France

June 16, 2020 Manufacturing and Production COVID-19, Sanofi

The coronavirus outbreak has changed the way that the world prioritises healthcare resources, and lay bare just how unprepared many …
bhf

British Heart Foundation funding trial of experimental drug designed to prevent blood clots in coronavirus patients

June 16, 2020 Manufacturing and Production COVID-19, blood clots, coronavirus

The British Heart Foundation is funding a trial for a drug that could prevent life-threatening blood clots that have been …
nz

New Zealand no longer virus free after two new cases come from Britain

June 16, 2020 Manufacturing and Production COVID-19, New Zealand, coronavirus, pandemic

New Zealand has reported its first new case of coronavirus after two COVID-19 positive women arrived in the country from …
sinovac

Sinovac’s COVID-19 vaccine successfully generates immune response at Phase 1/2

June 16, 2020 Manufacturing and Production, Research and Development COVID-19, Sinovac, Vaccine, coronavirus, pharma

As more than 130 efforts to develop an effective vaccine against the novel coronavirus continue to roll on, Beijing-based firm …
fda

FDA revokes emergency approval of hydroxychloroquine and chloroquine

June 16, 2020 Manufacturing and Production COVID-19, chloroquine, coronavirus, hydroxychloroquine

The FDA has revoked its emergency approval of hydroxychloroquine and chloroquine due to health risks and a lack of effectiveness …
marc_p2

Mundipharma names Marc Princen as Global Chief Executive Officer

June 15, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Mundipharma, appointment

Marc Princen was revealed in mid-June as the new Global Chief Executive Officer (CEO) of the Mundipharma network, having taken …
covid-19-4922384_640

COVID-19: UK and Europe life sciences regulatory developments

June 15, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Sidley Austin, coronavirus, pharma, regulation

Marie Manley, Partner, and Bethany Wise, Trainee Solicitor, at Sidley Austin look at UK and EU life sciences regulatory developments …
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Top Ten most popular articles on Pharmafile.com this week

June 12, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing coronavirus, top 10

The news this week continues to be dominated by breakthroughs in COVID-19 treatments, with a US clinical trial of the …
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