15:21 , Mar 21, 2017 |  BC Innovations  |  Distillery Therapeutics

Pulmonary

INDICATION: Chronic obstructive pulmonary disease (COPD) In vitro and cell culture studies identified a dual-acting PDE-4 inhibitor/ADRB2 agonist that could help treat COPD. In in vitro activity assays, a quinolone analog conjugated to a PDE-4 inhibitor...
07:00 , Sep 19, 2016 |  BC Week In Review  |  Clinical News

Indacaterol/glycopyrronium bromide: Additional Phase III data

Additional data from the 52-week, double-blind, international Phase III FLAME trial in 3,362 patients with moderate to very severe COPD showed that once-daily 110/50 ug Ultibro Breezhaler significantly reduced the annual rate of COPD exacerbations,...
07:00 , Sep 5, 2016 |  BioCentury  |  Strategy

Back to School: Haste, not waste

As researchers in industry and academia rapidly unravel molecular disease mechanisms and drug developers become more adept at intervening in disease pathways with drugs targeted to specific populations, the current clinical development paradigm cannot keep...
08:00 , Jan 11, 2016 |  BC Week In Review  |  Clinical News

Indacaterol/glycopyrronium bromide/mometasone fuorate: Phase III started

Vectura and Sosei said Novartis began a double-blind, international Phase III trial to compare 2 dose levels of inhaled QVM149 vs. 2 dose levels of Novartis’ inhaled indacaterol/mometasone furoate ( QMF149) or salmeterol xinafoate/fluticasone...
08:00 , Nov 23, 2015 |  BC Week In Review  |  Clinical News

Indacaterol/glycopyrronium bromide: Phase III data

Top-line data from the double-blind, international Phase III FLAME trial in 3,362 patients with moderate to very severe COPD showed that once-daily 110/50 ug Ultibro Breezhaler met the primary endpoint of non-inferiority to Seretide...
02:02 , Nov 18, 2015 |  BC Extra  |  Clinical News

Novartis' inhaler tops GSK's in Phase III COPD trial

Novartis AG (NYSE:NVS; SIX:NOVN) said Ultibro Breezhaler indacaterol/glycopyrronium bromide met the primary endpoint of non-inferiority and demonstrated superiority to Seretide salmeterol/fluticasone propionate from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in the Phase III FLAME trial to reduce...
08:00 , Nov 9, 2015 |  BC Week In Review  |  Clinical News

Indacaterol/glycopyrronium bromide regulatory update

FDA approved an NDA from Novartis for Utibron Neohaler indacaterol/glycopyrronium bromide for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Novartis said the...
07:00 , Jul 13, 2015 |  BC Week In Review  |  Clinical News

Indacaterol/glycopyrronium bromide: Phase III data

The identical, double-blind Phase III FLIGHT 1 and 2 trials in 2,043 patients with moderate to severe COPD showed that twice-daily QVA149 met the primary endpoint in each trial of improving FEV1 AUC from 0-12...
08:00 , Mar 2, 2015 |  BC Week In Review  |  Company News

Heptares, Sosei deal

Sosei acquired Heptares for $180 million in cash and up to $220 million in milestones related to pipeline progress. Sosei declined to disclose further financial terms, and Heptares could not be reached. Sosei will gain...
08:00 , Mar 2, 2015 |  BioCentury  |  Strategy

Sosei finds its R&D engine

Sosei Group Corp. has only one clinical candidate in development, but the Japanese biotech may have found its R&D engine in drug discovery platform company Heptares Therapeutics Ltd. The M&A deal marks a clean break...