Research and Development

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Phase 3 Libtayo monotherapy trial halted early due to strong benefit in advanced non-small cell lung cancer

April 29, 2020 Research and Development Cancer, Libtayo, Regeneron, Sanofi, lung cancer

A Phase 3 study of Sanofi and Regeneron’s Libtayo (cemiplimab) as a monotherapy for advanced or metastatic non-small cell lung …
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Australia calls for investigation into China’s coronavirus response

April 29, 2020 Research and Development Australia, COVID-19, China, coronavirus

Scott Morrison, the Australian Prime Minister, has called for an investigation into the origins of the COVID-19 coronavirus, as Australia …
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Pharmafile.com’s weekly COVID-19 news round-up

April 29, 2020 Research and Development BARDA, COVID-19, coronavirus, hydroxychloroquine

Hydroxychloroquine continues to feature in coronavirus news. Rick Bright, the Director of BARDA, alleges he was pushed out of his …
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EU approval for Novartis’ Cosentyx in active non-radiographic axial spondyloarthritis

April 29, 2020 Research and Development, Sales and Marketing Cosentyx, EU, Novartis, axial spondyloarthritis, pharma

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial …
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NICE backtracks to approve Janssen’s Stelara in ulcerative colitis

April 28, 2020 Manufacturing and Production, Research and Development Janssen, NICE, Stelara, ulcerative colitis

NICE has recommended Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC), a move which …

Reinventing the value equation

April 27, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Drug pricing, feature, real world data, real world evidence, real-world data, real-world evidence

There is a duty to ensure access to innovative treatments for patients with unmet need, but a health service gatekeeper …
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Leading COVID-19 hope remdesivir fails to provide clinical benefit in first randomised trial

April 24, 2020 Medical Communications, Research and Development COVID-19, Gilead, coronavirus, pharma, remdesivir

Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage …

Novartis’ Jakavi Phase 3 trial is first of its kind to hit main goal in steroid-refractory acute graft-versus-host disease

April 23, 2020 Research and Development Jakavi, Novartis, pharrma

Novartis has revealed impactful new Phase 3 data for its therapy Jakavi (ruxolitinib) in the treatment of patients with steroid-refractory …
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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 …
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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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