19:58 , Jun 15, 2018 |  BC Week In Review  |  Clinical News

Mylan expecting another delay for generic Advair

Mylan N.V. (NASDAQ:MYL) said it expects to receive a second complete response letter from FDA for an ANDA of a generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK). Any delay would be a...
22:40 , Jun 14, 2018 |  BC Extra  |  Company News

Mylan expecting another delay for generic Advair

Mylan N.V. (NASDAQ:MYL) said it expects to receive a second complete response letter from FDA for an ANDA of a generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK). Any delay would be a...
23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
19:59 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

Sandoz gets CRL for generic Advair

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said it is “highly unlikely” that it will be able to launch its version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in the U.S. this year...
23:58 , Feb 8, 2018 |  BC Extra  |  Company News

GSK breathes easier after delay for Sandoz’s generic Advair

Sandoz said it is “highly unlikely” that it will be able to launch its version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in the U.S. this year as planned after the Novartis AG (NYSE:NVS;...
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 , Apr 4, 2016 |  BC Week In Review  |  Clinical News

Advair Diskus: Phase IV data

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K.   Product: Advair Diskus ( Seretide - EU) salmeterol/fluticasone propionate   Business: Inflammation   Molecular target: Adrenergic receptor beta 2 ( ADRB2 ); Corticoid receptors   Description: Adrenergic receptor...
08:00 , Feb 15, 2016 |  BC Week In Review  |  Clinical News

Inspiolto Respimat: Additional Phase III data

Additional data from the double-blind, crossover, international Phase III ENERGITO trial in about 229 patients with moderate to severe COPD showed that once-daily oral Stiolto Respimat improved FEV1 AUC over 0-12 hours at week 6,...
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...
01:56 , Nov 20, 2015 |  BC Extra  |  Clinical News

Teva's inhalers meet in Phase III asthma studies

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said two multidose dry powder inhalers, fluticasone propionate/salmeterol MDPI formulation and fluticasone propionate MDPI formulation, met the primary endpoints of three Phase III trials to treat persistent asthma. The company...