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...
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...
16:45 , Mar 2, 2018 |  BC Week In Review  |  Clinical News

Asana reports Phase Ib data for ASN002 in atopic dermatitis

Asana BioSciences LLC (Lawrenceville, N.J.) reported data from a Phase Ib trial showing that atopic dermatitis candidate ASN002 was well tolerated. The most common adverse events reported were transient, mild headache and nausea. The...
16:24 , Feb 9, 2018 |  BC Week In Review  |  Company News

Janssen, Theravance in deal for intestinally-restricted JAK inhibitor

The Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) and Theravance Biopharma Inc. (NASDAQ:TBPH) entered into a deal to co-develop and commercialize Theravance's pan-Janus kinase (JAK) inhibitor TD-1473 and related back-up compounds in inflammatory...
20:38 , Feb 7, 2018 |  BC Extra  |  Company News

Janssen, Theravance in deal for intestinally-restricted JAK inhibitor

The Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) and Theravance Biopharma Inc. (NASDAQ:TBPH) entered into a deal to co-develop and commercialize Theravance's pan-Janus kinase (JAK) inhibitor TD-1473 and related back-up compounds in inflammatory...