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Forest and Almirall get FDA feedback on fixed dose combo of aclidinium and formoterol

Forest and Almirall get FDA feedback on fixed dose combo of aclidinium and formoterol

09-04-2014

US drugmaker Forest Laboratories and partner Almirall, Spain’s largest pharma company, say they have…

aclidiniumAlmirallForest LaboratoriesformoterolNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryUSA

US District Court upholds Mylan's US patents on Perforomist Inhalation Solution

25-03-2014

US generics major Mylan says the US District Court for the Northern District of West Virginia issued…

GenericsLegalMylan LaboratoriesNorth AmericaPatentsPerforomistRespiratory and PulmonaryTeva Pharmaceutical IndustriesUSA

US Court upholds damages award in Actelion/Asahi litigation

14-03-2014

Switzerland-based Actelion says that the California Supreme Court has denied the firm’ petition for…

ActelionAsahi KaseiBiotechnologyfasudilFinancialLegalNorth AmericaRespiratory and PulmonaryUSA

Tracleer “whistleblower” case by the US Department of Justice dismissed

Tracleer “whistleblower” case by the US Department of Justice dismissed

10-01-2014

In connection with a qui tam proceeding ("whistleblower case"), Swiss biotech firm Actelion previously…

ActelionBiotechnologyLegalNorth AmericaRespiratory and PulmonaryTracleerUSA

Surprise US FDA approval for United Thera’s Orenitram ER for PAH

Surprise US FDA approval for United Thera’s Orenitram ER for PAH

23-12-2013

In what was seen by some observers as unexpected, the US Food and Drug Administration has approved United…

BiotechnologyNorth AmericaOrenitramRegulationRespiratory and PulmonaryTreprostinilUnited Therapeutics

US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

19-12-2013

The US Food and Drug Administration late yesterday approved Anoro Ellipta (umeclidinium and vilanterol…

Anoro ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

GA and PhRMA partner on pilot scheme to enhance patient engagement in three therapy areas

05-11-2013

The USA’s Genetic Alliance and the Pharmaceutical Research and Manufacturers of America have announced…

Gastro-intestinalsHealthcareHematologyNorth AmericaPharmaceuticalRespiratory and Pulmonary

Actelion says PAH drug Opsumit now available in USA

Actelion says PAH drug Opsumit now available in USA

05-11-2013

Actelion has confirmed that Opsumit 10mg, an oral, dual endothelin receptor antagonist for pulmonary…

ActelionMarkets & MarketingNorth AmericaOpsumitPharmaceuticalRespiratory and Pulmonary

Theravance and GSK launch Breo Ellipta in USA

Theravance and GSK launch Breo Ellipta in USA

30-10-2013

GlaxoSmithKline and US partner Theravance today announced that Breo Ellipta for COPD is available to…

Breo ElliptaFinancialGlaxoSmithKlineMarkets & MarketingNorth AmericaPharmaceuticalRespiratory and PulmonaryTheravance

Forest Labs reports rise in sales and EPS doubles in second quarter results

23-10-2013

Forest Laboratories has released its second quarter results which showed that net sales for the quarter…

BystolicCNS DiseasesDalirespFinancialForest LaboratoriesLinzessNamendaNorth AmericaPharmaceuticalRespiratory and PulmonarySavellaTeflaroTudorza PressairViibryd

FDA allows OTC of Sanofi’s Nasacort

FDA allows OTC of Sanofi’s Nasacort

13-10-2013

The US Food and Drug Administration has approved Sanofi’s Nasacort Allergy 24HR nasal spray as an over-the-counter…

ChattemNasacort AQNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySanofi

FDA approves Bayer’s Adempas; firm accelerates drug candidates

FDA approves Bayer’s Adempas; firm accelerates drug candidates

09-10-2013

The US Food and Drug Administration late yesterday approved Adempas (riociguat), developed by German…

AdempasBayerCardio-vascularcopanlisibfinerenoneNorth AmericaOncologyPharmaceuticalRegulationResearchRespiratory and PulmonaryWomen's Health

US FDA backs updated product specifications for Surfaxin

04-10-2013

Discovery Laboratories says that the US Food and Drug Administration has agreed to the company's updated…

Discovery LaboratoriesNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySurfaxin

Bayer gains two orphan drug designations for riociguat

Bayer gains two orphan drug designations for riociguat

26-09-2013

Bayer’s investigational drug riociguat has been granted two orphan drug designations by the US Food…

BayerNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

FDA advisory panel gives thumbs up for Anoro Ellipta approval

11-09-2013

There was a bit of good news for UK pharma giant GlaxoSmithKline yesterday (LSE: GSK) and partner USA-based…

Anoro ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

GSK's Anoro Ellipta shows efficacy in COPD, say FDA briefing papers

09-09-2013

UK drug major GlaxoSmithKline's (LSE: GSK) Anoro Ellipta (vilanterol/umeclidinium) to treat chronic obstructive…

Anoro ElliptaBreo ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

Tris Pharma and FSC Labs enter Karbinal accord

04-09-2013

Drug delivery specialist Tris Pharma and fellow USA-based privately-held company FSC Laboratories have…

FSC LaboratoriesKarbinalLicensingNorth AmericaPharmaceuticalRespiratory and PulmonaryTris Pharma

Rigel shares fall as asthma compound fails to meet primary endpoint

27-08-2013

Shares of USA-based Rigel Pharmaceuticals (Nasdaq: RIGL) fell 10% to $3.27 in morning trading yesterday…

AstraZenecafostamatinibNorth AmericaPharmaceuticalResearchRespiratory and PulmonaryRigel Pharmaceuticals

Forest Labs and Almirall opt to delay US filing for combo COPD drug

15-08-2013

USA-based Forest Laboratories (NYSE: FRX) and Spain's largest drugmaker Almirall (ALM:MC) said late yesterday…

aclidiniumAlmirallForest LaboratoriesformoterolNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTudorza Pressair

Bayer's PAH/CTEPH drug gets unanimous backing from FDA advisory panel

07-08-2013

In what was largely expected following this week's briefing papers from US Food and Drug Administration…

AdempasBayerNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

FDA staffers back riociguat approval, but with modified dose

05-08-2013

On Tuesday (August 6), the US Food and Drug Administration's Renal Drugs Advisory Committee will discuss…

ActelionAdempasBayerNorth AmericaOpsumitPharmaceuticalRegulationRespiratory and PulmonaryriociguatTracleer

FDA advisory committee backs approval of Sanofi drug for OTC

01-08-2013

The US Food and Drug Administration's Nonprescription Drugs Advisory Committee (NDAC) voted 10 to six,…

Nasacort AQNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySanofiTeva Pharmaceutical Industries

Shares jump as Array BioPharma reports positive results for asthma drug

23-07-2013

US biotech firm Array BioPharma (Nasdaq: ARRY) saw its shares jump as it announced that its drug candidate…

Array BioPharmaBiotechnologyNorth AmericaResearchRespiratory and Pulmonary

US pulmonologists views on PAH prescribing options

19-07-2013

US pulmonologists surveyed by health care advisory firm Decision Resources consider a drug's effect on…

ActelionBayerMarkets & MarketingNorth AmericaOpsumitPharmaceuticalRespiratory and Pulmonaryriociguat

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