BC Extra | Jun 28, 2019
Clinical News

June 28 Clinical Quick Takes: Imfinzi extends survival in Phase III SCLC study; plus LSK, Pfizer, FibroGen, Aclaris and more

AZ's Imfinzi shows survival benefit in Phase III for SCLC  AstraZeneca plc (LSE:AZN; NYSE:AZN) said an interim analysis of the Phase III CASPIAN trial showed Imfinzi plus etoposide and platinum-based chemotherapy met the primary endpoint...
BC Week In Review | Feb 22, 2019
Clinical News

Pfizer reports increase in lung clots, death with high-dose Xeljanz in postmarket study

Pfizer Inc. (NYSE:PFE) disclosed an increase in pulmonary embolisms and deaths among rheumatoid arthritis patients receiving the twice-daily 10 mg dose of Xeljanz tofacitinib in the A3921133 postmarketing CV safety trial. The pharma said Feb....
BC Week In Review | Nov 16, 2018
Clinical News

Concert's hair loss product meets in Phase IIa, but with slower onset than Pfizer's

Concert Pharmaceuticals Inc. (NASDAQ:CNCE) reported Phase IIa data suggesting that its JAK inhibitor CTP-543 may have a later onset in treating alopecia areata than competing Phase IIa products from Pfizer Inc. (NYSE:PFE). Twice-daily 8 mg...
BC Extra | Nov 13, 2018
Clinical News

Concert stock falls as hair loss product meets in Phase IIa, but with slower onset than Pfizer's

Concert Pharmaceuticals Inc. (NASDAQ:CNCE) lost $3.47 (22%) to $12.59 on Monday after reporting Phase IIa data suggesting that its JAK inhibitor CTP-543 may have a later onset in treating alopecia areata than competing Phase IIa...
BC Week In Review | Mar 9, 2018
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...
BC Extra | Mar 8, 2018
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...
BC Week In Review | Jan 26, 2018
Clinical News

FDA panel to discuss Pfizer's Xeljanz for UC

FDA's Gastrointestinal Drugs Advisory Committee will meet on March 8 to discuss an sNDA from Pfizer Inc. (NYSE:PFE) for Xeljanz tofacitinib tablets to treat adults with moderate to severe active ulcerative colitis. In December, FDA...
BC Extra | Jan 19, 2018
Company News

FDA panel to discuss Pfizer's Xeljanz in UC

FDA's Gastrointestinal Drugs Advisory Committee will meet on March 8 to discuss an sNDA from Pfizer Inc. (NYSE:PFE) for Xeljanz tofacitinib tablets to treat adults with moderate to severe active ulcerative colitis. In December, FDA...
BC Innovations | Oct 5, 2017
Product R&D

Nimble move

Celgene Corp. ’s deal with Nimbus Therapeutics LLC is another vote of confidence that Nimbus’ computational drug design technology can solve druggability problems that trip up standard medicinal chemistry. The partnership gives Celgene access to...
BC Week In Review | Jul 21, 2017
Clinical News

FDA to discuss Xeljanz sNDAs in psoriatic arthritis, accepts UC sNDA

FDA’s Arthritis Advisory Committee will meet on Aug. 3 to discuss sNDAs from Pfizer Inc. (NYSE:PFE) for Xeljanz (Jaquinus) tofacitinib and Xeljanz XR extended release to treat adults with active psoriatic arthritis. Pfizer said FDA...
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