03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate of...
02:23 , Jun 30, 2018 |  BioCentury  |  Product Development

Defining access potential - before it’s too late

We see it everywhere: confirmation bias. Innovators believe in a drug, find the evidence to support its value, and dismiss or ignore the facts challenging their preferred story. But confirmation bias is particularly problematic thanks...
19:06 , Jun 6, 2018 |  BC Innovations  |  Distillery Therapeutics

Cardiovascular

INDICATION: Thrombosis Mouse studies suggest JAK inhibitors could help treat thrombosis in patients with JAK-2 mutations. In a mouse model of deep vein stenosis-induced thrombosis harboring a gain-of-function JAK-2 mutation, the JAK-1/JAK-2 inhibitor Jakafi ruxolitinib decreased...
16:32 , Jun 6, 2018 |  BC Innovations  |  Translation in Brief

JAKs and clots

Brigham and Women’s Hospital researchers have uncovered the mechanisms behind a major complication in bone marrow disorders by linking a JAK-2 mutation with thrombosis in patients and mice, and identified a way to treat blood...
19:25 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

Pfizer's Xeljanz gets label extension to include UC

FDA approved an sNDA for Xeljanz tofacitinib from Pfizer Inc. (NYSE:PFE) to treat adults with moderately to severely active ulcerative colitis. The agency said Xeljanz is the first oral drug approved for chronic use in...
18:59 , May 30, 2018 |  BC Extra  |  Company News

Pfizer's Xeljanz gets label extension to include UC

FDA approved an sNDA for Xeljanz tofacitinib from Pfizer Inc. (NYSE:PFE) to treat adults with moderately to severely active ulcerative colitis. The agency said Xeljanz is the first oral drug approved for chronic use in...
16:33 , Apr 20, 2018 |  BC Week In Review  |  Clinical News

FDA says Olumiant's thrombosis signal not a JAK class effect

FDA reviewers raised concerns over a possible increased risk of thrombosis with rheumatoid arthritis candidate Olumiant baricitinib from Eli Lilly and Co. (NYSE:LLY) and partner Incyte Corp. (NASDAQ:INCY). In briefing documents released on April 19 ahead...
23:46 , Apr 19, 2018 |  BC Extra  |  Company News

FDA says Olumiant's thrombosis signal not a JAK class effect

FDA reviewers raised concerns over a possible increased risk of thrombosis with rheumatoid arthritis candidate Olumiant baricitinib from Eli Lilly and Co. (NYSE:LLY) and partner Incyte Corp. (NASDAQ:INCY). In briefing documents released Thursday ahead of...
18:36 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

FDA GI panel backs Pfizer's Xeljanz for ulcerative colitis

FDA’s Gastrointestinal Drugs Advisory Committee voted unanimously in favor of approving twice-daily 10 mg Xeljanz tofacitinib from Pfizer Inc. (NYSE:PFE) to treat adults with moderately to severely active ulcerative colitis. The panel also voted 8-7...
22:42 , Mar 8, 2018 |  BC Extra  |  Company News

FDA GI panel backs Xeljanz for UC

FDA’s Gastrointestinal Drugs Advisory Committee voted unanimously in favor of approving twice-daily 10 mg Xeljanz tofacitinib from Pfizer Inc. (NYSE:PFE) to treat adults with moderately to severely active ulcerative colitis. The panel also voted 8-7...