21:21 , Jun 14, 2019 |  BioCentury  |  Product Development

Despite senior management shake-up, Novartis’ pipeline is primed to deliver

A string of departures at Novartis AG and strategic shifts by new CEO Vasant Narasimhan have produced a fairly thorough makeover of the executive committee he inherited in 2018. The team gains a pipeline that...
22:44 , May 22, 2019 |  BC Extra  |  Clinical News

May 22 Clinical Quick Takes: Lilly's mirikizumab meets Crohn's endpoints; plus Novartis, 89bio and more

Lilly's mirikizumab meets in Phase II for Crohn’s  Mirikizumab (LY3074828) from Eli Lilly and Co. (NYSE:LLY) met the primary and secondary endpoints of improving clinical and endoscopic measures of disease activity at week 12 vs....
23:55 , Apr 28, 2017 |  BioCentury  |  Politics, Policy & Law

Access and innovation in Japan

Regulatory reforms have paved the way for innovative therapies to launch in Japan before anywhere else in the world. This should result in earlier access to more innovative medicines than ever before - but only...
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...
07:00 , Aug 8, 2016 |  BC Week In Review  |  Clinical News

Sialanar glycopyrronium bromide regulatory update

EMA’s CHMP recommended approval of Sialanar glycopyrronium bromide from Proveca to treat persistent drooling and excessive salivation in children and adolescents with neurological conditions. The recommendation reverses a negative opinion CHMP issued in April due...
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

Glycopyrronium bromide regulatory update

EMA’s CHMP recommended against approval of Sialanar glycopyrronium bromide from Proveca to treat persistent drooling and excessive salivation in children and adolescents with neurological conditions. CHMP’s concerns related to a “lack of adequate data” on...
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...
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 salmeterol/fluticasone...
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...