GlaxoSmithKline (GSK), Theravance (THRX) Announces US FDA Approval of … – StreetInsider.com

GlaxoSmithKline (GSK), Theravance (THRX) Announces US FDA Approval of
StreetInsider.com
GlaxoSmithKline (NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) announced that the US Food and Drug Administration (FDA) has approved BREO ELLIPTA (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 …
Glaxo Wins U.S. Approval to Sell Breo Only to Adults With AsthmaBloomberg
FDA approves Glaxo's inhaler drug Breo Ellipta for new use in treating adults Minneapolis Star Tribune

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GSK and Theravance submit US sNDA for Breo Ellipta in asthma – The Pharma Letter


The Pharma Letter

GSK and Theravance submit US sNDA for Breo Ellipta in asthma
The Pharma Letter
Today's filing is based on data generated from the comprehensive clinical development program for FF/VI in asthma. The clinical development program comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients …
Glaxo, Theravance File Asthma Drug Application with FDANASDAQ
Glaxo submits new drug application for asthma treatmentIFA Magazine
GSK and Theravance Announce Submission to US Regulatory Authorities for MarketWatch
RTT 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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GSK, Theravance asthma drug shows improved lung function in study – Reuters


Drug Discovery & Development

GSK, Theravance asthma drug shows improved lung function in study
Reuters
The drug, already approved in the U.S. to treat chronic obstructive pulmonary disease (COPD) under the brand name Breo, proved more effective than fluticasone furoate alone for patients with moderate to severe asthma at the end of a 12-week treatment 
GSK, Theravance Report Positive Results For FF/VI In Late Stage Asthma StudyNASDAQ
Theravance and Glaxo say asthma study succeededSan Antonio Express

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GSK, Theravance Announce Relvar Ellipta Approval In Japan For Asthma … – RTT News

GSK, Theravance Announce Relvar Ellipta Approval In Japan For Asthma
RTT News
GlaxoSmithKline plc(GSK: Quote,GSK.L), and Theravance, Inc.(THRX: Quote), Friday said that Relvar Ellipta for the treatment of bronchial asthma got approval from the Japanese Ministry of Health, Labour and Welfare. The company said Relvar Ellipta is
Japan approves lung drugs from GSK/Theravance and SkyePharmaReuters
Glaxo's Relvar Lung Treatment Recommended by EU RegulatorBloomberg
GlaxoSmithKline Treatments Given Positive Opinion In Europe, Approved in JapanLondon South East

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GSK and Theravance file for FF/VI approval in the USA and Europe; Talks with … – The Pharma Letter

GSK and Theravance file for FF/VI approval in the USA and Europe; Talks with
The Pharma Letter
Asthma (100/25mcg and 200/25mcg): The regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate. • COPD (100/25mcg): The
GSK, Theravance seek approvals for FF/VI in US, EuropePharmaceutical Business Review
GSK and Theravance file next-generation Advair in USA, EUPharma Times

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GSK, Theravance seek FDA, European approval of COPD/asthma drug – Upstart (blog)

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GSK and Theravance Announce Regulatory Submissions for FF/VI in the US and … – MarketWatch (press release)

GSK and Theravance Announce Regulatory Submissions for FF/VI in the US and
MarketWatch (press release)
Asthma (100/25mcg and 200/25mcg): The regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate. COPD (100/25mcg): The
GSK, Theravance unveil Regulatory Submissions for FF/VI in US, EuropeRTT News
GSK files key new lung drug for regulatory approvalWHTC

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Glaxo to Hike Stake in Theravance – Zacks.com


Proactive Investors USA & Canada

Glaxo to Hike Stake in Theravance
Zacks.com
The increased holding by the pharma major reflects its confidence in the Relovair program, under which the companies are looking to replace one of Glaxo's best selling drugs Advair by evaluating treatment options for asthma and chronic obstructive
GlaxoSmithKline Boosts Stake In Theravance To 27%RTT News
GlaxoSmithKline to Increase Its Ownership in TheravanceMarketWatch (press release)
Glaxo Lifts Theravance StakeWall Street Journal
Triangle Business Journal
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GlaxoSmithKline Boosts Stake In Theravance To 27% – RTT News


RTT News

GlaxoSmithKline Boosts Stake In Theravance To 27%
RTT News
The move is said to be on the potential success of asthma drug Relovair, which is believed to be the successor of Seretide/Advair that logged sales of roughly $8.1 billion in 2011. Relovair is developed by Theravance and GlaxoSmithKline and is a
GlaxoSmithKline to Increase Its Ownership in TheravanceMarketWatch (press release)
Glaxo Lifts Theravance StakeWall Street Journal
GlaxoSmithKline invests $213M in Theravance Inc.Triangle Business Journal
DailyFinance
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