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EMA's Medicinal Committee Backs Eli Lilly's COVID-19 Antibody Therapy
Friday, March 5, 2021 - 1:51pm | 215European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for Eli Lilly and Co's (NYSE: LLY) bamlanivimab alone, and bamlanivimab plus etesevimab, in COVID-19 in patients. The opinion covers the...
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Regeneron's COVID-19 Antibody Cocktail Wins EU Positive Opinion
Friday, February 26, 2021 - 2:02pm | 280Regeneron Pharmaceuticals Inc (NASDAQ: REGN) has received a positive opinion from European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its COVID-19 antibody cocktail (casirivimab with imdevimab). The CHMP recommends that the antibody...
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European Medical Agency Starts Rolling Review Of Novavax's COVID-19 Vaccine Candidate
Wednesday, February 3, 2021 - 2:15pm | 209The European Medical Agency's (EMA) human medicines committee, or CHMP, has started a rolling review of Novavax Inc's (NASDAQ: NVAX) COVID-19 vaccine candidate, NVX-CoV2373. The CHMP's decision is based on preliminary results from laboratory studies and early...
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3 Pharma Companies Receive Positive EU Opinions
Friday, September 16, 2016 - 10:07am | 415Pfizer Inc. (NYSE: PFE), Amgen, Inc. (NASDAQ: AMGN) and Eli Lilly and Co (NYSE: LLY) received favorable opinions from the European Medicines Agency in response to their respective applications. Pfizer's IBRANCE® Pfizer disclosed that the European Medicines Agency (EMA)'s Committee for Medicinal...
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Amicus Therapeutics Gains 3% On Favorable EU Medicines Recommendation
Friday, April 1, 2016 - 2:37pm | 392Shares of Amicus Therapeutics, Inc. (NASDAQ: FOLD), a bio-pharmaceutical company that focuses on the treatment of rare and orphan diseases, were trading higher by 3 percent Friday afternoon. Amicus Therapeutics announced earlier in the day that the European Committee for Medicinal Products for...
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Leerink Comments On Orexigen Therapeutics, Says Current Projections Could Prove To Be 'Conservative'
Wednesday, March 4, 2015 - 1:01pm | 110In a report published Wednesday, Leerink analyst Paul Matteis commented on Orexigen Therapeutics, Inc. (NASDAQ: OREX) and wrote that following a positive opinion from the CHMP, the company expects a final opinion from the EMA on the Mysimba (Contrave) marketing authorization application. Matteis...