Eugene

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LATEST

Arranta Bio Progresses New $100-M Mfg Facility for Advanced Biologics
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Arranta Bio, a CDMO focused on live therapeutic products and the human microbiome, has reported the mechanical completion of GMP suites at its new $100-million manufacturing facility in Watertown, Massachusetts.…

Gilead Sciences’ Chairman and CEO Provides Update on Potential COVID-19 Antiviral
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Daniel O’Day, Chairman and CEO of Gilead Sciences, issued an open letter on April 10, 2020 to provide an update on the clinical developments of the company’s antiviral drug, remdesivir,…

Pharma Companies Advance Potential COVID-19 Treatments
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The latest from pharma companies on potential COVID-19 treatments with news from Lilly, Sanofi, GSK, AstraZeneca, CSL Behring, and Bausch Health. Lilly, US Gov’t Partner To Study Potential COVID-19 TherapyEli…

Pharma Companies Step Up Relief Efforts Against COVID-19
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The latest contributions from J&J, Gilead, BMS, Merck & Co, Bayer, Novo Nordisk, Lilly, and Daiichi Sankyo in funding and donations supporting relief efforts against COVID-19. J&J Commits $50 M…

FDA Updates Policy for COVID-19 Diagnostic Tests; Roche, Thermo Fisher, Abbott Get Authorization
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The US Food and Drug Administration (FDA) has issued an updated guidance (March 16, 2020) to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and…

Roche To Test Arthritis Drug Actemra for COVID-19 Pneumonia
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Roche reports that it is working with the US Food and Drug Administration (FDA) to initiate a Phase III clinical trial to evaluate the safety and efficacy of Roche’s Actemra/RoActemra…

EU Forms COVID-19 Advisory Panel; EMA, FDA Co-Chair Global Regulatory Workshop
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The European Commission launches an advisory panel on the novel coronavirus (COVID-19), and the European Medicines Agency and the FDA co-chair first global regulatory workshop on COVID-19. European Commission Launches…

FDA Postpones US Inspections, Issues Clinical Trials Guidance Due to COVID-19
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The US Food and Drug Administration (FDA) has announced that it has temporarily postponed all domestic routine surveillance facility inspections due to the novel coronavirus (COVID-19) outbreak and has issued…

Pfizer Outlines Five-Point Plan for Combating COVID-19
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Pfizer has issued a five-point plan for its collaboration with industry and government on R&D and manufacturing for vaccines and treatments against the novel coronavirus (COVID-19).  “In this troubling time,…

Sanofi, Regeneron Begin Clinical Trial for Antiviral Kevzara for Coronavirus
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Sanofi and Regeneron Pharmaceuticals, Inc., a Tarrytown, New York-based biopharmaceutical company, have started a clinical program evaluating Kevzara (sarilumab), an antiviral compound, in patients hospitalized with severe COVID-19 (the novel…