Tag: Glaxo

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UPDATE 2-FDA panel backs Glaxo asthma drug for adults, not adolescents – Reuters


Channel News Asia

UPDATE 2-FDA panel backs Glaxo asthma drug for adults, not adolescents
Reuters
The panel voted 16-4 that Breo Ellipta should be approved for once daily treatment of asthma in adults 18 years and older. It voted 19-1 that the data did not support approval for use in children aged 12 to 17. The FDA is not obliged to follow the …
U.S. Panel Backs Glaxo's Breo for Adults With Asthma, Not KidsBloomberg
GSK's Breo for asthma? FDA panel says yes–but only in adultsFiercePharma
FDA panel backs Glaxo asthma drug for adults, not adolescentsBusiness Insider
WallStreet.org –Fox Business
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FDA panel backs Glaxo asthma drug for adults, not adolescents – Reuters


Channel News Asia

FDA panel backs Glaxo asthma drug for adults, not adolescents
Reuters
The panel voted 16 to 4 that the product, Breo Ellipta, should be approved for once daily treatment of asthma in adults 18 years and older. It voted 19 to 1 that the data did not support approval for use in children aged 12 to 17. The FDA is not …
Critical inspection of GlaxoSmithKline plc (ADR) (NYSE:GSK) by FDA …WallStreet.org
FDA panel backs Glaxo inhaler for adults, not adolescentsTown Hall
GSK and Theravance Announce Outcome of US FDA Advisory Committee on …MarketWatch
Healio
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View full post on asthma – Google News

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Glaxo, Theravance File Asthma Drug Application with FDA – NASDAQ

Glaxo, Theravance File Asthma Drug Application with FDA
NASDAQ
LONDON–GlaxoSmithKline PLC (GSK.LN) and Theravance Inc. ( THRX ) have submitted a supplemental new drug application to the U.S. Food and Drug Administration for a drug used for treatment of asthma in patients aged 12 years and older. The British …
GSK and Theravance Announce Submission to US Regulatory Authorities for …MarketWatch
Glaxo And Theravance Submits Supplemental NDA For Breo ElliptaLondon South East

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Prospect of generic asthma drug Advair hits Glaxo – Philly.com


The West Australian

Prospect of generic asthma drug Advair hits Glaxo
Philly.com
GlaxoSmithKline P.L.C.'s top-selling drug by far is the asthma medication Advair, which accounts for about 20 percent of company revenue, but generic competition got a bit closer to reality this week. Advair is delivered to patients through an inhaler …
Mylan shares jump after FDA lays out guidelines for asthma genericMarketWatch (blog)
FDA Offers Guidance for Advair KnockoffsWall Street Journal
Glaxo May Face Generic Advair Sooner Than ExpectedForbes
Chicago Tribune –PMLiVE –FiercePharma
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Glaxo starting late-stage study of asthma drug – Businessweek

Glaxo starting late-stage study of asthma drug
Businessweek
British drugmaker GlaxoSmithKline PLC said Monday that it is starting two late-stage patient studies of an experimental biologic drug as an add-on treatment for patients with severe, uncontrolled asthma. Both studies will compare the safety and …
GlaxoSmithKline starts final-stage tests on severe asthma drugFox News
GSK Begins Phase lll Program for Mepolizumab in Severe Refractory AsthmaFox Business
GSK starts final-stage tests on severe asthma drugWHTC
PipelineReview.com (press release)
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Glaxo Tries to Shake Marketing Questions on Advair – Wall Street Journal


Wall Street Journal

Glaxo Tries to Shake Marketing Questions on Advair
Wall Street Journal
GlaxoSmithKline's $3 billion criminal and civil settlement with the U.S. government this week raises questions about the future of asthma treatment Advair.
Glaxo Executives Cited in Case Now Lead Sanofi, ActelionBusinessweek
WSJ: Glaxo Tries to Shake Marketing QuestionsNASDAQ
Ex-Glaxo execs in U.S. case now lead other drugmakersBend Bulletin
FiercePharma –NPR (blog)
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Glaxo Tries to Shake Marketing Questions – Wall Street Journal


The Guardian

Glaxo Tries to Shake Marketing Questions
Wall Street Journal
GlaxoSmithKline's $3 billion criminal and civil settlement with the U.S. government this week raises questions about the future of asthma treatment Advair.
Glaxo Executives Cited in Case Now Lead Sanofi, ActelionBusinessweek
WSJ: Glaxo Tries to Shake Marketing QuestionsNASDAQ
Ex-Glaxo execs in U.S. case now lead other drugmakersBend Bulletin
FiercePharma –NPR (blog)
all 46 news articles »

View full post on asthma – Google News