BioCentury | Jul 19, 2019
Regulation

A half step forward for heart failure as FDA guidance leaves key question unanswered

A draft FDA guidance for heart failure endpoints could spark investment and accelerate development of cardiovascular therapies. But companies still don’t have a clear sense of when and whether they’ll need to gather mortality data...
BC Extra | Sep 19, 2017
Clinical News

Limited benefit for beta blockers in combo therapy

In a study published in the Journal of the American College of Cardiology , researchers at Monash University in collaboration with the University of North Carolina at Chapel Hill and others showed that beta blockers provided...
BC Week In Review | Sep 12, 2016
Clinical News

Sparsentan: Phase II data

Top-line combined data from the 3 sparsentan cohorts in the double-blind, international Phase II DUET trial in 96 evaluable patients with focal segmental glomerulosclerosis showed that once-daily oral sparsentan met the primary endpoint of reducing...
BC Week In Review | May 2, 2016
Company News

Novartis sales and marketing update

The U.K.’s NICE issued draft guidance recommending the use of Entresto sacubitril/valsartan from Novartis to treat heart failure in patients with moderate to very severe symptoms with reduced ejection fraction and whose heart failure is...
BC Extra | Apr 27, 2016
Company News

NICE backs Novartis' Entresto

The U.K.'s NICE issued draft guidance recommending heart failure drug Entresto sacubitril/valsartan from Novartis AG (NYSE:NVS; SIX:NOVN). The drug is recommended for patients with moderate to very severe symptoms with reduced ejection fraction, and whose...
BC Week In Review | Apr 11, 2016
Clinical News

Sparsentan: Completed Phase II enrollment

Retrophin completed enrollment of >100 patients in the double-blind, international Phase II DUET trial comparing 200, 400 and 800 mg oral RE-021 once daily for 8 weeks vs. once-daily oral irbesartan. Patients are eligible to...
BC Week In Review | Nov 16, 2015
Clinical News

Aclerastide: Phase III discontinued

Derma said it will discontinue its 2 double-blind Phase III trials evaluating once-daily 0.03% DSC127 in patients with chronic, non-healing diabetic foot ulcers based on a pre-specified interim futility analysis of the primary endpoint of...
BioCentury | Nov 16, 2015
Product Development

Myo my

Phase II readouts showing that omecamtiv mecarbil improves cardiac output and physiology could translate into better outcomes and quality of life for chronic heart failure patients, if Amgen Inc. and Cytokinetics Inc. decide to move...
BC Week In Review | Dec 22, 2014
Company News

Teva sales and marketing update

Teva launched a generic version of amlodipine/valsartan/hydrochlorothiazide in the U.S. to treat hypertension. Novartis AG (NYSE:NVS; SIX:NOVN, Basel, Switzerland) markets the combination of the calcium channel blocker amlodipine, the angiotensin receptor blocker valsartan and the...
BC Week In Review | Dec 15, 2014
Clinical News

CCX140: Additional Phase II data

Additional data from a 52-week, double-blind, European Phase II trial in 196 evaluable patients with diabetic nephropathy showed once-daily 5 mg oral CCX140 plus standard of care (SOC) met the primary endpoint of reducing UACR...
Items per page:
1 - 10 of 147