08:00 , Jan 5, 2015 |  BC Week In Review  |  Clinical News

Nebivolol/valsartan regulatory update

FDA issued a complete response letter to Actavis for its fixed-dose combination of nebivolol and valsartan to treat hypertension. The company said it will review the letter and determine next steps. Last September, FDA’s Cardiovascular...
07:00 , Oct 6, 2014 |  BioCentury  |  Finance

4Q14 Financial Markets Preview: Commercial race in HCV

HCV and cancer immunotherapy again top the list of milestones in 4Q14, as investors expect approval of three new HCV regimens plus clinical data for combos looking to challenge Gilead Sciences Inc. and AbbVie Inc....
07:00 , Oct 6, 2014 |  BioCentury  |  Finance

3Q14 Stock Wrap-Up: Going big again

For the second quarter in a row, only the large caps finished in the black in 3Q14. In the over $5 billion segment, which was up 9%, gainers outnumbered decliners 22-9, while the decliners led...
07:00 , Sep 15, 2014 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Actavis plc (NYSE:ACT) gained $3.09 to $234.38 last week after FDA's Cardiovascular and Renal Drugs Advisory Committee voted 6-4 against approval of an NDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension....
07:00 , Sep 15, 2014 |  BC Week In Review  |  Clinical News

Nebivolol/valsartan regulatory update

FDA's Cardiovascular and Renal Drugs advisory committee voted 6-4 against approval of an NDA from Actavis for a fixed-dose combination of nebivolol and valsartan to treat hypertension. The product has a Dec. 24 PDUFA date....
02:32 , Sep 11, 2014 |  BC Extra  |  Company News

FDA panel rebuffs Actavis' nebivolol/valsartan

FDA's Cardiovascular and Renal Drugs advisory committee voted 6-4 against approval of an NDA from Actavis plc (NYSE:ACT) for a fixed-dose combination of nebivolol and valsartan to treat hypertension. The product has a Dec. 24...
02:14 , Sep 9, 2014 |  BC Extra  |  Politics & Policy

Reviewers ask FDA for CV 'polypill' development pathway

FDA reviewers asked the agency's Cardiovascular and Renal Drugs Advisory Committee for advice on a development pathway for fixed-dose combination therapies for hypertension. In polypill and if sufficient adherence could be achieved without rigorous monitoring....
01:21 , Sep 6, 2014 |  BC Extra  |  Company News

FDA reviewers question nebivolol/valsartan benefit

FDA reviewers questioned whether a fixed-dose combination of nebivolol and valsartan from Actavis plc (NYSE:ACT) provides a "clinically meaningful" benefit in patients with hypertension. The reviewers noted the combo led to a greater reduction in...
08:00 , Mar 3, 2014 |  BC Week In Review  |  Clinical News

Nebivolol/valsartan regulatory update

Forest submitted an NDA to FDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension. Forest said the application was based on a double-blind pivotal trial in 4,161 hypertensive patients that compared fixed...
08:00 , Nov 18, 2013 |  BC Week In Review  |  Company News

Actavis Inc., Alkem Laboratories, Amerigen Pharmaceuticals Ltd., Forest Laboratories, Glenmark, Hetero Drugs Ltd., Indchemie Health Specialties Pvt. Ltd., Torre

Forest settled two lawsuits that alleged the generic companies' ANDAs for generic versions of hypertension drug Bystolic nebivolol infringed U.S. Patent No. 6,545,040. In March 2012, Forest filed Forest Laboratories Inc. et al v. Torrent...