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Boehringer’s nintedanib approved in Europe for systemic sclerosis-associated interstitial lung disease

April 22, 2020
Research and Development, Sales and Marketing Boehringer Ingelheim, EU, nintedanib, pharma

The European Commission has moved to authorise Boehringer Ingelheim’s nintedanib in Europe for the treatment of systemic sclerosis-associated interstitial lung …

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

April 22, 2020
Research and Development COVID-19, coronavirus, hydroxychloroquine

Hydroxychloroquine has faced setbacks as a potential COVID-19 treatment, as it failed a clinical trial in France and a study …

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First in-home COVID-19 testing kit approved by the FDA

April 22, 2020
Research and Development COVID-19, Testing kits, coronavirus, testing swabs

The US Food and Drug Administration have granted emergency clearance to the first in-home COVID-19 testing kit. The nasal swab …

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AbbVie’s Imbruvica scoops up 11th FDA approval with chronic lymphocytic leukaemia/small lymphocytic lymphoma nod

April 22, 2020
Research and Development, Sales and Marketing Cancer, FDA, imbruvica, leukaemia

AbbVie’s Imbruvica (ibrutinib) has scored its 11th FDA approval, this time in combination with rituximab for the treatment of chronic …

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National Institutes of Health says COVID-19 patients should not take hydroxychloroquine

April 22, 2020
Research and Development COVID-19, coronavirus, hydroxychloroquine

Experts at the US National Institutes of Health (NIH) have drafted treatment guidelines for the use of hydroxychloroquine in COVID-19 …

Bayer’s Vitrakvi becomes first tumour-agnostic therapy approved by NICE for NHS patients with NTRK fusion+ cancer

April 21, 2020
Manufacturing and Production, Sales and Marketing Bayer, Cancer, NICE, UK, Vitrakvi, tumour agnostic

Bayer’s oral TRK inhibitor Vitrakvi (larotrectinib) has just been recommended by NICE in the treatment of advanced neurotrophic tyrosine receptor …

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Deaths in England and Wales hit 20 year high due to COVID-19 fatalities

April 21, 2020
Manufacturing and Production COVID-19, COVID-19 UK, coronavirus, coronavirus uk

Deaths in England and Wales have hit a 20 year high, boosted by fatalities from the COVID-19 coronavirus. The Office …

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Phase 3 kidney cancer trial of Bristol Myers Squibb’s Opdivo and Exelixis’ Cabometyx meets primary endpoint

April 21, 2020
Manufacturing and Production BMS, Bristol-Myers Squibb, Exelixis, bristol myers squibb

Bristol Myers Squibb and Exelixis have announced that the Phase 3 trial investigating the combination of Opdivo (nivolumab) and Cabometyx …

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Five-year data supports early treatment with Novartis’ Mayzent in secondary progressive multiple sclerosis

April 21, 2020
Manufacturing and Production, Research and Development Mayzent, Novartis, pharma

Novartis has pulled back the curtain on five-year data from an extension trial for its sphingosine 1-phosphate receptor modulator Mayzent …

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FDA to take steps to ease shortages of drugs for COVID-19 patients on ventilators

April 21, 2020
Manufacturing and Production COVID-19, Ventilators, coronavirus

The FDA is to allow small compound pharmacies to fill the shortages of medicines needed for patients with COVID-19 who …

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How the intended role of generic medicines is being undermined in America

April 20, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Drug pricing, US, feature, generic medicines, generics

The introduction of a generic medicine should, in theory, incentivise companies to lower the price of the original drug, creating healthy …

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Novartis to sponsor large clinical trial of hydroxychloroquine in COVID-19 patients

April 20, 2020
Sales and Marketing COVID19 Coronavirus, coronavirus, covid19

The FDA and Novartis have agreed to move forward with a Phase 3 clinical trial to evaluate the effectiveness of …

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Gilead’s remdesivir significantly reduces COVID-19 symptoms in rhesus monkeys in NIH trial

April 20, 2020
Business Services, Medical Communications, Sales and Marketing COVID-19, Gilead, National Institutes of Health, coronavirus, remdesivir

A study from the National Institutes of Health has shed more light on the efficacy of Gilead’s promising antiviral therapy …

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English COVID-19 cases to be tracked by ethnicity

April 20, 2020
Sales and Marketing African-Americans, BAME, COVID-19, coronavirus

Cases of coronavirus are set to be tracked by ethnicity in England following an announced government review. The governments have …

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Incyte’s Pemazyre becomes FDA’s first and only approved unresectable, advanced cholangiocarcinoma treatment

April 20, 2020
Sales and Marketing FDA, Incyte, pharma

The FDA has approved the United States’ first and only treatment for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma, …

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Hydroxychloroquine fails COVID-19 clinical trial in France

April 20, 2020
Sales and Marketing COVID-19, chloroquine, coronavirus, hydroxychloroquine

The malaria treatment hydroxychloroquine is facing further scrutiny as a coronavirus treatment after failed trials in France. The most recent …

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FDA cautions that drug reviews will be slower due to COVID-19

April 17, 2020
Medical Communications COVID-19, FDA, coronavirus

The FDA has warned that they may not be able to sustain its current levels of timely reviews and approvals …

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US Government’s BARDA to fund Moderna’s coronavirus vaccine by $483m

April 17, 2020
Medical Communications, Research and Development BARDA, COVID-19, Moderna, coronavirus, pharma

Moderna has secured $483 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), to drive development and …

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Top Ten most popular articles on Pharmafile.com this week

April 17, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, coronavirus, top 10

Hydroxychloroquine dominates the news as the potential COVID-19 treatment has gone through various trials. A Chinese study showed that the …

Leaked data show Gilead’s remdesivir allows severe COVID-19 patients to be discharged after six days

April 17, 2020
Medical Communications, Research and Development COVID-19, Gilead, coronavirus, remdesivir

The clinical benefit of Gilead’s promising antiviral therapy Remdesivir has been touted in the treatment of severe cases of COVID-19 …

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