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Boehringer’s Ofev approved in EU for the treatment of IPF

19-01-2015

German family-owned pharma major Boehringer Ingelheim revealed today that the European Commission has…

Boehringer IngelheimEuropeOfevPharmaceuticalRegulationRespiratory and Pulmonary

GlaxoSmithKline files for EU extended indication for Volibris in PAH

GlaxoSmithKline files for EU extended indication for Volibris in PAH

11-12-2014

UK pharma major GlaxoSmithKline says it has filed a regulatory submission to the European Medicines Agency…

EuropeGilead SciencesGlaxoSmithKlineLetairisPharmaceuticalRegulationRespiratory and PulmonaryVolibris

AstraZeneca’s Duaklir Genuair approved in the EU for COPD

AstraZeneca’s Duaklir Genuair approved in the EU for COPD

25-11-2014

The European Commission has granted marketing authorization for Anglo-Swedish pharma major AstraZeneca’s…

AstraZenecaDuaklir GenuairPharmaceuticalRegulationRespiratory and PulmonaryUK

More November EMA/CHMP recommendations

22-11-2014

A total of 10 new medicines have been recommended for approval at the November 2014 meeting of the European…

apremilastBoehringer IngelheimCelgene Corp.DermatologicalsEuropeNephrology and HepatologyNeurologicalnintedanibOfevOtezlaPharmaceuticalRasagilineRegulationRespiratory and PulmonarySanofiShionogiTeva Pharmaceutcal Industries

GlaxoSmithKline files for US and EU approval of mepolizumab

GlaxoSmithKline files for US and EU approval of mepolizumab

05-11-2014

UK pharma major GlaxoSmithKline says it has filed regulatory submissions in the USA and Europe for mepolizumab…

BarclaysBiotechnologyBosatriaEuropeGlaxoSmithKlineImmunosuppressantsmepolizumabRegulationRespiratory and PulmonaryUnited StatesUSA

Boehringer Ingelheim's Spiriva Respimat NDA for asthma accepted for review by FDA

Boehringer Ingelheim's Spiriva Respimat NDA for asthma accepted for review by FDA

04-11-2014

German family-owned drug major Boehringer Ingelheim has had its Spiriva Respimat (tiotropium bromide)…

Boehringer IngelheimGermanyPharmaceuticalRegulationRespiratory and PulmonarySpirivaSpiriva Respimat

IQWiG finds no added benefit for GSK’s Anoro Ellipta in COPD

21-10-2014

According to the findings of an early benefit assessment under the German Act on the Reform of the Market…

Anoro ElliptaGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationRespiratory and Pulmonary

New Zealand's PHARMAC funds four new medicines as part of major agreement with Novartis

New Zealand's PHARMAC funds four new medicines as part of major agreement with Novartis

20-10-2014

New Zealand's Pharmaceutical Managment Agency PHARMAC has agreed to fund four new medicines for which…

Antibiotics and Infectious diseasesCardio-vascularglycopyrroniumindacaterolNew ZealandNovartisOmalizumabPharmaceuticalRegulationRespiratory and PulmonaryTobramycin

US FDA approves Genentech’s Esbriet and Boehringer Ingelheim’s Ofev for IPF

US FDA approves Genentech’s Esbriet and Boehringer Ingelheim’s Ofev for IPF

16-10-2014

The US Food and Drug Administration has approved Esbriet (pirfenidone), from Roche subsidiary Genentech,…

Boehringer IngelheimEsbrietGenentechnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

New Zealand approval of Novartis multiproduct proposal

10-10-2014

New Zealand’s Pharmaceutical Management Agency PHARMAC has announced the approval of an agreement with…

NeurologicalNew ZealandOncologyPharmaceuticalRegulationRespiratory and Pulmonary

Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

26-09-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a…

aclidiniumAlmirallAstraZenecaBrimica GenuairDuaklir GenuairEuropeformoterolPharmaceuticalRegulationRespiratory and Pulmonary

Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD

Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD

25-09-2014

German family-owned pharma major Boehringer Ingelheim Pharmaceuticals has received US Food and Drug Administration…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivaUSA

FDA accepts Tuzistra XR NDA for full review

FDA accepts Tuzistra XR NDA for full review

15-09-2014

The US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR, a prescription…

LicensingPharmaceuticalRegulationRespiratory and PulmonaryTris PharmaTuzistraUSAVernalis

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

02-09-2014

UK-based Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory…

EuropeEvohalerFinancialFluticasone PropionateGenericsGlaxoSmithKlineMylanProsonixRegulationRespiratory and Pulmonary

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

21-08-2014

UK pharma giant GlaxoSmithKline revealed late yesterday that the US Food and Drug Administration has…

Arnuity ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryUSA

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

15-08-2014

There was good news late yesterday for German family-owned pharma major Boehringer Ingelheim, when an…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivatiotropiumUS Food and Drug AdministrationUSA

Vertex received European approval for CF drug Kalydeco

Vertex received European approval for CF drug Kalydeco

01-08-2014

US biotech firm Vertex Pharmaceuticals has announced that the European Commission has approved Kalydeco…

BiotechnologyCommittee for Medicinal Products for Human UseCystic fibrosisKalydecoPharmaceuticalRegulationRespiratory and PulmonaryUSAVertex Pharmaceuticals

FDA approves Boehringer’s Striverdi Respimat for COPD

FDA approves Boehringer’s Striverdi Respimat for COPD

01-08-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimPharmaceuticalPulmonologyRegulationRespiratory and PulmonaryStriverdi RespimatUSA

US breakthrough status for InterMune’s pirfenidone

US breakthrough status for InterMune’s pirfenidone

21-07-2014

US biotech firm InterMune’s Esbriet (pirfenidone) has been granted Breakthrough Therapy designation…

BiotechnologyEsbrietFood and Drug AdministrationInterMunepirfenidoneRare diseasesRegulationRespiratory and PulmonaryUSA

US breakthrough designation in IPF for Boehringer’s nintedanib

US breakthrough designation in IPF for Boehringer’s nintedanib

17-07-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation for German family-owned…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

FDA accepts Teva’s NDA for albuterol MDPI

FDA accepts Teva’s NDA for albuterol MDPI

15-07-2014

Israel-based generic giant Teva Pharmaceuticals Industries says that the US Food and Drug Administration…

albuterolExercise-induced bronchospasmGenericsPulmonologyRegulationRespiratory and PulmonaryTeva Pharmaceutical IndustriesUSA

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

02-07-2014

The US subsidiary of German family-owned drug major Boehringer Ingelheim says that the New Drug Application…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

Boehringer submits tiotropium + olodaterol Respimat for European approval in COPD

Boehringer submits tiotropium + olodaterol Respimat for European approval in COPD

02-07-2014

German family-owned pharma major Boehringer Ingelheim says it has submitted Marketing Authorization Applications…

Boehringer IngelheimEuropePharmaceuticalRegulationRespiratory and Pulmonarytiotropium + olodaterol Respimat

GSK and Theravance submit US sNDA for Breo Ellipta in asthma

GSK and Theravance submit US sNDA for Breo Ellipta in asthma

30-06-2014

US pharma giant GlaxoSmithKline and US partner Theravance have submitted a supplemental New Drug Application…

Breo ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravanceUSA

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