07:00 , Sep 29, 2014 |  BC Week In Review  |  Clinical News

Humira adalimumab regulatory update

FDA approved an sBLA from AbbVie for Humira adalimumab to treat moderately to severely active Crohn's disease (CD) in pediatric patients ages ≥6 years who have had an inadequate response to corticosteroids or immunomodulators, such...
08:00 , Mar 7, 2013 |  BC Innovations  |  Targets & Mechanisms

ALL emerges from relapse

Separate teams led by researchers from New York University and Columbia University have identified mutations in 5ʹ-nucleotidase cytosolic II that predict relapse, drug resistance and poor prognosis in acute lymphoblastic leukemia.1,2 Inhibiting the enzyme could...
07:00 , Oct 29, 2012 |  BC Week In Review  |  Clinical News

Simponi golimumab: Phase III data

The Phase III PURSUIT maintenance study in 1,228 patients with moderately to severely active UC showed that low- and high-dose subcutaneous Simponi as maintenance therapy each met the primary endpoint of a greater proportion of...
07:00 , May 28, 2012 |  BC Week In Review  |  Clinical News

Simponi golimumab: Phase III data

The double-blind, international Phase III PURSUIT trial in 774 patients showed that induction therapy with low- and high-dose subcutaneous Simponi each met the primary endpoint of a greater proportion of patients achieving a clinical response...
23:34 , May 21, 2012 |  BC Extra  |  Clinical News

Simponi meets Phase III UC endpoint

Johnson & Johnson (NYSE:JNJ) said induction therapy with low- and high-dose Simponi golimumab each met the primary endpoint of a greater proportion of patients achieving a clinical response at week six vs. placebo in the...
08:00 , Jan 30, 2012 |  BC Week In Review  |  Clinical News

Remicade infliximab regulatory update

EMA's CHMP issued a positive opinion to expand the label of Remicade infliximab from Johnson & Johnson to include ulcerative colitis (UC) in patients ages 6-17 years who have an inadequate response to standard of...
07:00 , Aug 22, 2011 |  BC Week In Review  |  Clinical News

6-mercaptopurine: Phase II started

Researchers at the National Institute for Health Research Oxford Biomedical Research Centre began a U.K. Phase II trial to evaluate 75 mg/m 2 oral 6MP daily plus 20 mg/m 2 methotrexate weekly in 65...
07:00 , Aug 6, 2007 |  BioCentury  |  Regulation

Tysabri & infection

Tysabri & infection Tysabri & infection Eleven opportunistic and other uncommon infections were seen in Crohn's disease patients who received Tysabri in clinical trials, while none occurred in patients on placebo. Three patients died after...
07:00 , Jul 28, 2003 |  BioCentury  |  Product Development

Maintaining hope for Antegren

Though Antegren natalizumab from Biogen Inc. and Elan Corp. plc failed to meet the primary endpoint in a Phase III study, it is too soon to pass judgement on its utility for Crohn's disease. A...
07:00 , May 1, 2000 |  BC Week In Review  |  Clinical News

PRO-PredictR assays: Marketed

Researchers published in Gastroenterology a study of 92 pediatric patients receiving 6-mercaptopurine (6-MP) or azathioprine therapy to treat IBD, showing that levels of certain metabolites of the drugs correlated with therapeutic response and risk of...