CVT Announces That FDA Continues to Review Ranexa(R) Applications
... data from the MERLIN TIMI-36 study could support expansion of the existing ranexa indication to first line angina. Following submission of the initial sNDA...otential HbA1c reduction claims in patients with coronary artery disease. ranexa is currently indicated for the treatment of chronic angina in patients who ...FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa(R)
...ing expansion to the approved product labeling for ranexa to include a first line angina indication and a si... in the MERLIN TIMI-36 study. Patients receiving ranexa had a 37 percent reduction in their relative risk ...I-36 study could support expansion of the existing ranexa indication to first line angina. ...Cell Therapeutics, Inc. (CTI) Appoints Jim Fong as Vice President, Commercial Operations
...ns subject to closing conditions including obtaining certain third party consents, is expected in mid-November. "Jim did a great job at the launch of ranexa and streamlining CVT's commercial operations. With his prior expertise in marketing and sales, and the launch of a novel blockbuster anti-cancer agent...CV Therapeutics Reports 2007 Third Quarter Financial Results
...revenue. The $18.4 million of net product sales of ranexa in the quarter ended September 30, 2007 represents...consisted of $45.7 million of net product sales of ranexa and $14.7 million of collaborative research revenu...d to the completion of the MERLIN TIMI-36 study of ranexa and lower regadenoson research and development exp...Ranexa(R) Significantly Reduces Ischemia in Women in MERLIN TIMI-36 Study
...ation of the safety and efficacy we have seen with ranexa in other clinical trials and in commercial use," s...I-36 study could support expansion of the existing ranexa indication to first line angina. In September 2007...d a significant reduction in cautionary language. ranexa is currently indicated for the treatment of chroni...CV Therapeutics Identifies Potential Anti-Diabetic Mechanism of Action for Ranexa
-- New Preclinical Information May Correlate with Clinical HbA1c Reductions Observed in Phase 3 CARISA and MERLIN TIMI-36 Clinical Trials -- PALO ALTO, Calif., July 9, 2007 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. announced today that researchers have completed preliminary preclinical studi...New Data Shows Ranexa(R) Increases Glucose-Stimulated Insulin Secretion
...ons in hemoglobin A1c (HbA1c) levels observed with ranexa in cardiovascular patients with diabetes from the ...yndromes and diabetes) clinical trials. In CARISA, ranexa reduced HbA1c levels by an average of up to 0.7 percentage points. In MERLIN-TIMI 36, ranexa lowered HbA1c versus placebo by an average of 0.43...CV Therapeutics Announces Topline MERLIN TIMI-36 Results
...al designed to evaluate the efficacy and safety of ranexa during acute and long-term treatment in approximat...in the study and randomized to receive intravenous ranexa or placebo, followed by long-term outpatient treatment with ranexa extended-release tablets or placebo. All patients ...CV Therapeutics' Board of Directors Rejects Astellas Unsolicited Proposal
...ish a solid cash position. The full promotional launch of the improved U.S. ranexa labeling is just beginning, the introduction of ranexa in Europe is imminent, and Lexiscan is showing real growth in the marketpla...CV Therapeutics Reports 2008 Fourth Quarter and Full Year Financial Results
... $100 million in convertible debt in 2008 - - ranexa prescriptions for first week in February hit recor...an $250 million in non-dilutive net cash, grew our ranexa business by 64 percent year-over-year, and saw our..., the full promotional launch of the improved U.S. ranexa labeling and the imminent introduction of...CV Therapeutics Reports 2008 Third Quarter Financial Results
... Astellas and $0.3 million of amortization of our $70.0 million upfront license payment from the Menarini Group (Menarini) for the exclusive rights to ranexa in the European Union and certain other countries. The $3.2 million of collaboration, milestone and other revenue includes a $3.0 million milestone pa...CV Therapeutics Announces License Agreement for Ranexa(R) in Europe With Menarini Group
...total, the agreement grants rights to Menarini for ranexa in 68 countries, including the 27 countries of the...e development milestones are linked to approval of ranexa in Europe for certain additional indications that ... of physician details and promotional spending for ranexa for a specified period of time. In addition to u...CV Therapeutics Reports Option Grants Under Nasdaq Marketplace Rule 4350
...injection for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. ranexa is also approved for use in the European Union as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequ...CV Therapeutics Receives European Approval for the Brand Name Ranexa(R)
...he brand name Latixa. "Securing approval for the ranexa brand name in Europe provides important brand syne... and chief executive officer of CV Therapeutics. ranexa is approved for use in Europe as an add-on therapy...tients unable to undergo adequate exercise stress. ranexa is also approved for use in the European Union as ...CV Therapeutics Reports 2008 Second Quarter Financial Results
... - ranexa Revenue Grows 15 Percent Quarter-over-Quarter - PALO ALTO, Calif., July 3...pared to the prior quarter ended March 31, 2008 was primarily due to higher ranexa marketing and sales expense. The decrease in costs and expenses in the qu...CV Therapeutics Reports 2008 First Quarter Financial Results
...revenue. The $22.0 million of net product sales of ranexa in the quarter ended March 31, 2008 represents an ...ssociated with various development projects, lower ranexa marketing and sales expenses and lower general and...d to the completion of the MERLIN TIMI-36 study of ranexa and lower regadenoson research and development exp...