08:00 , Feb 17, 2014 |  BC Week In Review  |  Clinical News

VX-509: Additional Phase IIb data

Additional data from a double-blind, international Phase IIb trial in 358 patients with active RA who had an inadequate response to methotrexate showed that all 4 doses of VX-509 plus methotrexate for 24 weeks significantly...
07:00 , Oct 28, 2013 |  BC Week In Review  |  Clinical News

VX-509: Phase IIb data

A double-blind, international Phase IIb trial in 358 patients with active RA who had an inadequate response to methotrexate showed that all 4 doses of VX-509 plus methotrexate for 24 weeks met the co-primary endpoints...
07:00 , Oct 28, 2013 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory milestones Actelion Ltd. (SIX:ATLN) was off CHF0.20 to CHF69.15 on Friday after EMA's CHMP backed approval of Opsumit macitentan for pulmonary arterial hypertension (PAH). Actelion gained CHF4.55 on the week. The move included a...
23:39 , Oct 21, 2013 |  BC Extra  |  Clinical News

Vertex's VX-509 meets in Phase IIb RA trial

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said all four doses of VX-509 plus methotrexate for 24 weeks each met the co-primary endpoints of improving ACR20 response rate and DAS28 scores from baseline to week 12 vs. placebo...
07:00 , May 7, 2012 |  BC Week In Review  |  Clinical News

VX-509: Phase IIb start

This month, Vertex will begin a 6-month, international Phase IIb trial to evaluate once and twice-daily VX-509 plus methotrexate in about 350 patients. Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), Cambridge, Mass.   Product: VX-509   Business: Autoimmune...
08:00 , Mar 5, 2012 |  BioCentury  |  Strategy

Not optional

Galapagos N.V. desired to control Phase II studies of its GLPG0634 oral Janus kinase-1 inhibitor in rheumatoid arthritis, but also wanted an experienced Phase III partner. The result was last week's hybrid option-like licensing deal...
08:00 , Jan 9, 2012 |  BioCentury  |  Finance

PDUFAs produce yawns

Stephen Hansen Senior Writer  There are more than twice as many PDUFA dates this year than last - at least 40 vs. 17 - but only a handful of potential approvals are drumming up interest...
07:00 , Sep 12, 2011 |  BC Week In Review  |  Clinical News

VX-509: Phase IIa data

Top-line data from the intent-to-treat (ITT; n=204) population of a double-blind, international Phase IIa trial showed that twice-daily 50, 100 and 150 mg oral VX-509 each met the co-primary endpoint of significantly improving ACR20 response...
07:00 , Sep 12, 2011 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory milestones Mela Sciences Inc. (NASDAQ:MELA) rose $1.26 (56%) to $3.50 on Wednesday after receiving CE Mark approval in the EU for MelaFind to aid in the detection of melanoma. The company plans to launch...
00:59 , Sep 7, 2011 |  BC Extra  |  Clinical News

Vertex's VX-509 meets RA endpoint

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said data from a Phase IIa trial of VX-509 to treat rheumatoid arthritis support moving the oral Janus kinase 3 ( JAK-3 ) inhibitor into Phase IIb testing. Twice-daily 50, 100...