22:23 , Aug 11, 2017 |  BioCentury  |  Regulation

Foundation for inclusion

Hosting a patient-focused drug development workshop was the National Kidney Foundation Inc. ’s first step in assuming the role of facilitator to collect patient perspectives that will shape R&D for kidney disease. On Aug. 4,...
07:00 , Aug 1, 2016 |  BC Week In Review  |  Company News

Vertex, Trek Therapeutics deal

Vertex granted Trek exclusive, worldwide rights to develop and commercialize lomibuvir ( VX-222 ) and merimepodib ( VX-497 ) to treat infectious disease. Vertex is eligible for undisclosed milestones and royalties. Lomibuvir, a non-nucleoside HCV...
08:00 , Jan 18, 2016 |  BC Week In Review  |  Clinical News

FF-10501: Preliminary Phase I/II data

Preliminary data from 17 patients with relapsed or refractory myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) in the Phase I portion of an open-label, dose-escalation, U.S. Phase I/II trial showed that twice-daily 50-400 mg/m...
07:00 , Sep 2, 2013 |  BC Week In Review  |  Clinical News

CellCept mycophenolate mofetil regulatory update

Roche's Chugai Pharmaceutical Co. Ltd. (Tokyo:4519, Tokyo, Japan) majority-owned subsidiary submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for an additional form of CellCept mycophenolate mofetil called Cellcept Powder for Oral...
08:00 , Mar 4, 2013 |  BioCentury  |  Strategy

Simple solution

Aurinia Pharmaceuticals Inc. says reverse-merging with Isotechnika Pharma Inc. gives investors what they want: a publicly traded entity with a simplified ownership structure for voclosporin. The company is looking to raise $25-$28 million to start...
07:00 , Oct 1, 2012 |  BC Week In Review  |  Clinical News

Myfortic mycophenolic acid regulatory update

FDA approved a single REMS for all immunosuppressants containing mycophenolate to address the risks of first-trimester miscarriage and congenital birth defects. The REMS includes an education program for prescribers, a medication guide, a registry for...
07:00 , Oct 1, 2012 |  BC Week In Review  |  Clinical News

CellCept mycophenolate mofetil regulatory update

FDA approved a single REMS for all immunosuppressants containing mycophenolate to address the risks of first-trimester miscarriage and congenital birth defects. The REMS includes an education program for prescribers, a medication guide, a registry for...
01:09 , Sep 27, 2012 |  BC Extra  |  Company News

FDA unveils REMS for mycophenolate drugs

FDA approved a single REMS for all immunosuppressants containing mycophenolate to address the risks of first-trimester miscarriage and congenital birth defects. The REMS includes an education program for prescribers, a medication guide, a registry for...
07:00 , Jul 23, 2012 |  BC Week In Review  |  Clinical News

CellCept mycophenolate mofetil regulatory update

FDA approved an updated label for Roche's CellCept mycophenolate mofetil to include a black box warning on embryofetal toxicity, malignancies and serious infections. The agency also added a warning stating that the use of CellCept...
08:00 , Nov 21, 2011 |  BC Week In Review  |  Clinical News

CellCept mycophenolate mofetil: Phase III data

A double-blind, double-dummy, international Phase III trial in 227 patients with lupus nephritis who responded to induction therapy showed that once-daily 2 g oral CellCept met the primary endpoint of significantly improving time to treatment...