20:04 , Feb 15, 2019 |  BC Week In Review  |  Company News

Mylan launches first U.S. generic of GSK's Advair

Mylan N.V. (NASDAQ:MYL) launched Wixela Inhub salmeterol/fluticasone, the first generic version of Advair Diskus, in the U.S. at a list price 70% less than the branded version. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) markets Advair Diskus. Both...
01:15 , Feb 1, 2019 |  BC Week In Review  |  Clinical News

Mylan gets first FDA approval for an Advair generic

FDA approved Wixela Inhub salmeterol/fluticasone from Mylan N.V. (NASDAQ:MYL), the first generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK), to treat asthma or chronic obstructive pulmonary disease (COPD). Mylan plans to launch the...
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,...