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FDA accepts Celgene's ozanimod filing ahead of BMS close Bristol-Myers Squibb scored more bragging rights for its coming megamerger: The FDA is now officially reviewing one of the "Big 5" Celgene candidates touted as cornerstones of the deal. And it's ozanimod, the blockbuster MS prospect whose applica.. 2019-06-11 Merck has supplies in hand as measles cases spike to highest number in 25 years The U.S. is experiencing the greatest spike in measles cases in 25 years, but Merck, the sole producer of the measles vaccine for the U.S., says it has production in hand.The increase in cases has reportedly come from unvaccinated travelers bringing the virus .. 2019-05-05 Lonza plagued by supply problems after China plant explosion An explosion at a chemical plant in China that killed 62 people not only exposed weaknesses in China’s safety oversight but it also exposed weaknesses in the global ingredient supply chain. The disruption from the blast has exacerbated shortages for Swiss pha.. 2019-04-23 Novartis’ Cosentyx beats J&J, Lilly to land first-in-class Chinese psoriasis nod Novartis’ psoriasis blockbuster Cosentyx has beaten out rivals from Eli Lilly and Johnson & Johnson as the first interleukin-17A inhibitor approved in China.China’s National Medical Product Administration has approved Cosentyx to treat moderate-to-severe.. 2019-04-08 Sage wins OK for depression drug Zulresso. Up next? Major marketing challenges Sage Therapeutics now boasts the first-ever approval for a prescription drug for postpartum depression, thanks to the FDA’s Tuesday nod for Zulresso. But it also faces some big challenges in launching the new drug.Regulators greenlighted the product—a one-ti.. 2019-03-21 Valsartan probe teaches FDA lesson about impurities in manufacturing It was a U.S. drugmaker that first alerted the FDA that the valsartan API it got from a Chinese ingredient maker contained a potentially dangerous impurity. And in the process of investigating, the FDA learned something it hadn’t known: that a combination of .. 2018-09-10
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