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...
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 patients....
07:00 , Aug 6, 2007 |  BioCentury  |  Regulation

Tysabri & infection

Tysabri & infection...
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...