BioCentury | Apr 21, 2020
Product Development

FDA green-lights more than 70 COVID-19 trials via treatment acceleration program

FDA’s Coronavirus Treatment Acceleration Program has cleared the start of 72 therapeutics trials, with another 211 development programs being planned, the agency said Monday. CTAP launched on March 31 and has received 950 inquiries and...
BioCentury | Aug 11, 2017
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,...
BioCentury | Aug 1, 2016
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 NS5B polymerase inhibitor, and...
BioCentury | Jan 18, 2016
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...
BioCentury | Sep 2, 2013
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...
BioCentury | Mar 4, 2013
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...
BioCentury | Oct 1, 2012
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...
BioCentury | Oct 1, 2012
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...
BioCentury | Sep 27, 2012
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...
BioCentury | Jul 23, 2012
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...
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