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With Kevzara in COVID-19 testing, Sanofi and Regeneron won't divvy up their rightsAs part of CEO Paul Hudson's grand vision at Sanofi, the French drugmaker announced late last year a restructuring of its long-standing antibody partnership with Regeneron. But one of those partnered2020/3/20
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Roche takes $25M in BARDA backing to accelerate Actemra trial in COVID-19Roche has stepped on the gas in testing Actemra for coronavirus patients, thanks to a little more help from the U.S. government. With $25 million in backing from the U.S. Biomedical Advanced Research2020/3/20
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Alexion plans phase 2 study of Soliris in COVID-19 in coming days: reportThe race for a COVID-19 therapeutic has attracted many of the biggest names in biopharma, and now Alexion is gettingready to place a bet on its own Soliris,GlobalDatareports. The company, which marke2020/3/13
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Merck's Keytruda inches toward another biomarker-based OK with latest priority reviewMerck & Co.’s immuno-oncology competitors have tried, so far fruitlessly, to use the investigational biomarker tumor mutational burden to help them win approvals. But regulators apparently like w2020/3/13
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FiercePharmaAsia—AZ-Daiichi's fast Enhertu nod; Astellas' 2 partnered approvals, CAR-T buyAsian drugmakers had a few busy days before the end of 2019. Daiichi Sankyo and partner AstraZeneca won FDA approval for HER2 antibody-drug conjugate Enhertu four months ahead of schedule. Astellas,w2020/1/3
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With cancer kickoff, Amgen bets on BeiGene's fast-growing Chinese sales forceCompared with multinational rivals such as Novartis, Roche and AstraZeneca, Amgen didn’t have a strong oncology presence in China. That situation has ended with theofficial launchof a strategic partn2020/1/3
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Migraine, cholesterol upstarts top the list of FDA decisions to watch this quarterIt's a new year, which means it's a new opportunity for drugmakers hoping to pass FDA muster for new therapies––some of which could be sniffing after blockbuster sales. In the first quarter, the FDA2020/1/2
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NICE stiff-arms Akcea's rare disease med Waylivra on unacceptably high priceThe FDA quashed Akcea Therapeutics'hopes for Waylivra in the U.S. in 2018, at least temporarily, but the rare disease med did win a European nod last year. Now, though, it's running into reimbursemen2020/1/2
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Homegrown rivals to Pfizer, Merck cash cow vaccines win nods in ChinaPfizer’s Prevnar 13 and Merck & Co.’s HPV franchise Gardasil are the world’s best-selling vaccines, and China sales have been driving growth for both of them. Now, thanks to new approvals, they'r2019/12/30
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Regeneron to lay off field staffers as it restructures Sanofi partnershipWith its long-standing partnership with Sanofi in its final days, Regeneron is in a belt-tightening phase as it prepares for its new reality. Now, the first blow has landed with some of the New York-2019/12/30