BioCentury | May 22, 2019
Clinical News

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

...the primary endpoint of improving peak forced expiratory volume in 1 second (FEV1) vs. twice-daily Advair...
BioCentury | Feb 15, 2019
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...
...LSE:GSK; NYSE:GSK), London, U.K. Product: Wixela Inhub salmeterol/fluticasone Business: Pulmonary, Inflammation Mark Zipkin Adoair, Advair, Advair Diskus, Seretide, salmeterol/fluticasone propionate Wixela...
BioCentury | Feb 1, 2019
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...
...product in the second half of February. GSK had reported £3.1 billion ($4.2 billion) in Advair...
...N.V. (NASDAQ:MYL), Canonsburg, Pa. Product: Wixela Inhub salmeterol/fluticasone Business: Pulmonary, Inflammation Sandi Wong Adoair, Advair, Advair Diskus, Seretide, salmeterol/fluticasone propionate GlaxoSmithKline...
BioCentury | Jun 15, 2018
Clinical News

Mylan expecting another delay for generic Advair

...a second complete response letter from FDA for an ANDA of a generic version of Advair...
...GlaxoSmithKline plc (NYSE:GSK; LSE:GSK). Any delay would be a reprieve for GSK, which reported worldwide Advair...
...according to Mylan. At least two other companies have submitted ANDAs to FDA for generic Advair...
BioCentury | Jun 14, 2018
Company News

Mylan expecting another delay for generic Advair

...a second complete response letter from FDA for an ANDA of a generic version of Advair...
...GlaxoSmithKline plc (NYSE:GSK; LSE:GSK). Any delay would be a reprieve for GSK, which reported worldwide Advair...
...according to Mylan. At least two other companies have submitted ANDAs to FDA for generic Advair...
BioCentury | Apr 6, 2018
Finance

Fundamentally driven

...Novartis AG (NYSE:NVS; SIX:NOVN) FDA issues a complete response letter for a generic version of Advair...
BioCentury | Feb 16, 2018
Clinical News

Sandoz gets CRL for generic Advair

...said it is “highly unlikely” that it will be able to launch its version of Advair...
...not respond in time for publication to inquiries regarding plans for its generic Advair candidate. Advair...
...disease (COPD). Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Generic Advair salmeterol/fluticasone propionate Business: Inflammation Jaime De Leon Adoair Advair Advair Diskus salmeterol/fluticasone propionate Seretide VR315 GlaxoSmithKline...
BioCentury | Feb 8, 2018
Company News

GSK breathes easier after delay for Sandoz’s generic Advair

...said it is “highly unlikely” that it will be able to launch its version of Advair...
...not respond in time for publication to inquiries regarding plans for its generic Advair candidate. Advair...
...corticosteroid. It is approved for asthma and chronic obstructive pulmonary disease (COPD). Jaime De Leon Adoair Advair Advair Diskus AirFluSal Forspiro IrFlosol Forspiro salmeterol/fluticasone propionate Seretide VR315 GlaxoSmithKline...
BioCentury | Sep 19, 2016
Clinical News

Indacaterol/glycopyrronium bromide: Additional Phase III data

...significantly reduced the annual rate of COPD exacerbations, the primary endpoint, by 11% vs. twice-daily Seretide...
...3.59 vs. 4.03, p=0.003). Ultibro Breezhaler also significantly increased median time to first exacerbation vs. Seretide...
...the median time to first moderate or severe exacerbation (127 vs. 87 days, p<0.001) vs. Seretide...
BioCentury | Apr 4, 2016
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...
...international Phase IV VESTRI (SAS115358) trial in 6,250 asthma patients ages 4-11 showed that twice-daily Advair Diskus...
...were hospitalizations and there were no asthma-related deaths or intubations in either treatment arm. Additionally, Advair Diskus...
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