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22 HOURS AGO - Yahoo! News

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FDA staff backs biosimilar to Remicade; J&J and AbbVie fall

U.S. Food and Drug Administration staff members on Friday said Celltrion Inc's biosimilar form of Johnson & Johnson's Remicade arthritis drug appeared "highly similar" to the widely used branded product. The news sent shares of J&J, whose annual Remicade sales of $6.5 billion are mostly in the United States, down almost 4 percent. It also hit AbbVie Inc and Amgen ...

Tags: FDA staff backs biosimilar to Remicade; J&J and AbbVie fall,  Food And Drug Administration Latest News

22 HOURS AGO - Yahoo! News

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FDA rejects expanded use of Vertex's cystic fibrosis drug

(Reuters) - The U.S. Food and Drug Administration has denied the expanded use of Vertex Pharmaceutical Inc's bestseller, Kalydeco, in certain cystic fibrosis patients, the company said on Friday. The regulator rejected the company's application for using the drug in cystic fibrosis patients aged 2 or older, who have one of 23 residual function mutations. Cystic fibrosis is caused by ...

Tags: FDA rejects expanded use of Vertex's cystic fibrosis drug,  Food And Drug Administration Latest News

FEB 05, 2016 - Reuters

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FDA rejects expanded use of Vertex cystic fibrosis drug

(Reuters) - The U.S. Food and Drug Administration has denied the expanded use of Vertex Pharmaceutical Inc's bestseller, Kalydeco, in certain cystic fibrosis patients, the company said on Friday.

Tags: FDA rejects expanded use of Vertex cystic fibrosis drug,  Food And Drug Administration Latest News

FEB 05, 2016 - Yahoo! News

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FDA reviewers support Celltrion's biosimilar Remicade

(Reuters) - U.S. Food and Drug Administration staff members on Friday said clinical data from Celltrion Inc's biosimilar form of blockbuster arthritis drug Remicade indicated it is "highly similar" to the branded product in terms of safety, purity and potency. FDA scientists released their supportive findings ahead of a scheduled meeting on Tuesday of an independent medical advisory panel to ...

Tags: FDA reviewers support Celltrion's biosimilar Remicade,  Food And Drug Administration Latest News

FEB 04, 2016 - Yahoo! News

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Lundbeck wins U.S. backing that may extend use of anti-depressant

Denmark's Lundbeck said on Thursday a U.S. Food and Drug Administration (FDA) committee had recommended that its anti-depression drug Brintellix can add improved cognitive functions to its information leaflet, a first of its kind. "Lundbeck will be the only product on the market with a leaflet on cognitive effects. FDA is increasing its focus on this area, which means doctors ...

Tags: Lundbeck wins U.S. backing that may extend use of anti-depressant,  Food And Drug Administration Latest News