Research and Development

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Jyseleca secures European approval in rheumatoid arthritis

September 28, 2020 Research and Development, Sales and Marketing Europe, Jyseleca, arthritis, pharma

The European Commission has awarded approval to Gilead and Galpagos for their oral JAK inhibitor Jyseleca (filgotinib) as a treatment …
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Novel prophylactic nasal spray reduced COVID-19 replication by 96% in animal studies

September 28, 2020 Research and Development, Sales and Marketing COVID-19, Ena Respiratory, Nasal Spray

Australian biotech Ena Respiratory has revealed new data demonstrating that its novel nasal spray almost halted replication of the SARS-CoV-2 …

Novartis’ Zolgensma hits regulatory hurdle after FDA asks to review another study

September 24, 2020 Research and Development FDA

The FDA has requested an additional study in older children being treated with Novartis’ Zolgensma in the review process for …
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FDA grants Emergency Use Authorization for first antibody point-of-care COVID-19 test

September 24, 2020 Research and Development

The FDA has issued an Emergency Use Authorization (EUA) for the first antibody (serology) point-of-care test for coronavirus.  This is …
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Science community calls for transparency on AstraZeneca’s halted US COVID-19 vaccine trial

September 23, 2020 Research and Development AstraZeneca, COVID-19, Vaccine

The halting of AstraZeneca’s COVID-19 vaccine trial around the world was cause for much initial concern over the eventual safety …
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Fujifilm’s Avigan reduces recovery time in non-severe COVID-19 patients

September 23, 2020 Research and Development, Sales and Marketing

Fujifilm has announced promising new Phase 3 findings demonstrating that its antiviral therapy Avigan (favipravir) had a statistically significant impact …
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FDA set to announce stricter criteria for COVID-19 vaccines to receive Emergency Use Authorization

September 23, 2020 Research and Development

The FDA is set to release new guidelines that would raise safety and efficacy requirements required for a COVID-19 vaccine …
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Contracting flu and COVID-19 simultaneously increases the risk of death, new study shows

September 23, 2020 Research and Development coronavirus vaccine, flu vaccine, vaccines

Public Health England has warned that catching seasonal flu and coronavirus at the same time could almost double the risk …
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Pharmafile.com’s weekly COVID-19 news round-up

September 23, 2020 Research and Development COVID-19, coronavirus

The coronavirus news this week largely focuses on clinical trial results, with Pfizer saying that participants in a late-stage trial …
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Positive five-year Keytruda survival data revealed at ESMO in metastatic, PD-L1+ non-small cell lung cancer

September 22, 2020 Manufacturing and Production, Research and Development ESMO 2020, MSD, keytruda, pharma

MSD took the opportunity at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 to unveil new Phase 3 …
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New Lenvima/Keytruda combo data in a range of cancers presented at ESMO 2020

September 21, 2020 Research and Development, Sales and Marketing Cancer, ESMO2020, Eisai, Lenvima, MSD, keytruda

New data from two studies investigating the combination of Eisai’s multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) and MSD’s blockbuster …
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Piqray and Faslodex combo extends survival in HR+/HER2-, PIK3CA+ advanced breast cancer at ESMO 2020

September 21, 2020 Research and Development, Sales and Marketing Cancer, ESMO 2020, Novartis, pharma

New data has been unveiled for the combination of Novartis’ Piqray (alpelisib) with AstraZeneca’s Faslodex (fulvestrant) in the treatment of …
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Promising Phase 2 data for Sanofi and Regeneron’s PD-1 inhibitor Libtayo in locally advanced basal cell carcinoma

September 18, 2020 Medical Communications, Research and Development Cancer, ESMO 2020, Libtayo, Regeneron, Sanofi, pharma

Promising Phase 2 data has been released at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 for Sanofi …
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One in seven Russian COVID-19 vaccine recipients display side-effects, says Health Minister

September 18, 2020 Medical Communications, Research and Development COVID-19, Russia, Sputnik V, Vaccine

Around one in seven patients who have received Russia’s vaccine against COVID-19 have displayed side-effects in clinical studies, according to …
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Novartis’ Tafinlar/Mekinist combo improves five-year relapse-free survival in new Phase 3 data

September 17, 2020 Research and Development Novartis, Tafinlar, mekinist, melanoma

Novartis has unveiled promising new Phase 3 data for its combination of Tafinlar (dabrafenib) with Mekinist (trametinib) in the treatment …
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