Regulation - Boehringer Ingelheim, Pharmaceutical

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Boehringer’s Vargatef gains approval in EU for lung cancer

Boehringer’s Vargatef gains approval in EU for lung cancer

28-11-2014

The European Commission has granted EU marketing authorization for German family-owned pharma major Boehringer…

Boehringer IngelheimEuropeOncologyPharmaceuticalRegulationVargatef

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

Added benefit of Jardiance not proven, says IQWiG

19-11-2014

Following an examination as to whether Jardiance (empagliflozin) offers an added benefit over appropriate…

Boehringer IngelheimDiabetesEli LillyGermanyJardiancePharmaceuticalPricingRegulation

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

FDA study shows Pradaxa reduces stroke risk but raises chances of GI bleeding

FDA study shows Pradaxa reduces stroke risk but raises chances of GI bleeding

03-11-2014

A study carried out by the US Food and Drug Administration on Pradaxa (dabigatran etexilate mesylate)…

Boehringer IngelheimHematologyPharmaceuticalPradaxaRegulationResearchUSAWarfarin Sodium

NICE recommends Pradaxa for DVT and PE

NICE recommends Pradaxa for DVT and PE

31-10-2014

In draft guidance published today, the UK health costs watchdog the National Institute for Health and…

Boehringer IngelheimCardio-vascularPharmaceuticalPradaxaPricingRegulationUK

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

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

EU approval for Boehringer and Lilly’s insulin glargine biosimilar

EU approval for Boehringer and Lilly’s insulin glargine biosimilar

10-09-2014

The European Commission granted marketing authorization for US drug major Eli Lilly and family-owned…

AbasriaBasaglarBiosimilarsBoehringer IngelheimDiabetesEli LillyEuropeInsulinLantusPharmaceuticalRegulationSanofi

UK NICE wants more info on type 2 diabetes drug Jardiance

UK NICE wants more info on type 2 diabetes drug Jardiance

28-08-2014

In a new draft guidance issued today, the UK drugs watchdog the National Institute for Health and Care…

Boehringer IngelheimDiabetesEli LillyJardiancePharmaceuticalPricingRegulationUK

FDA expands indication for Eliquis to treatment of DVT and PE

FDA expands indication for Eliquis to treatment of DVT and PE

22-08-2014

US pharma majors Bristol-Myers Squibb and Pfizer late yesterday said that the US Food and Drug Administration…

Boehringer IngelheimCardio-vascularEliquisPfizerPharmaceuticalPulmonary embolismRegulationUSA

Tentative FDA approval for Lilly and Boehringer Ingelheim's Basaglar

Tentative FDA approval for Lilly and Boehringer Ingelheim's Basaglar

19-08-2014

The US Food and Drug Administration yesterday granted tentative approval for Basaglar (insulin glargine…

AbasriaBasaglarBiosimilarsBoehringer IngelheimDiabetesEli LillyInsulin Glargine [rDNA origin] InjectionLantusPharmaceuticalRegulationUSA

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

US FDA approves Jardiance for adults with type 2 diabetes

US FDA approves Jardiance for adults with type 2 diabetes

02-08-2014

The US Food and Drug Administration on Friday approved Jardiance (empagliflozin) tablets as an adjunct…

Boehringer IngelheimDiabetesEli LillyEuropeGermanyJardiancePharmaceuticalRegulationUSA

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

BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators

BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators

24-07-2014

German family-owned drug major Boehringer Ingelheim has been accused of withholding ‘important analyses’…

Boehringer IngelheimDabigatranGermanyHematologyPharmaceuticalPradaxaPyridinesRegulationUKUniversity of California

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

Boehringer Ingelheim’s Pradaxa available in UK for DVT

Boehringer Ingelheim’s Pradaxa available in UK for DVT

15-07-2014

German family-owned drug major Boehringer Ingelheim says that Pradaxa (dabigatran etexilate) will be…

Boehringer IngelheimDeep vein thrombosisHematologyPharmaceuticalPradaxaRegulationUK

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

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

26-06-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to idarucizumab, an…

Boehringer IngelheimCardio-vascularidarucizumabPharmaceuticalPradaxaRegulationResearchUSA

Boehringer Ingelheim pulls out of hepatitis C drug development

Boehringer Ingelheim pulls out of hepatitis C drug development

23-06-2014

German family-owned pharma major Boehringer Ingelheim revealed that, following a re-evaluation of its…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

Boehringer and Lilly re-file empagliflozin NDA with FDA

Boehringer and Lilly re-file empagliflozin NDA with FDA

19-06-2014

The US subsidiary of German family-owned drugmaker Boehringer Ingelheim and pharma major Eli Lilly have…

Boehringer IngelheimDiabetesEli LillyempagliflozinPharmaceuticalRegulationUSA

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