Regulation - Boehringer Ingelheim

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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

Boehringer’s Pradaxa gains added indication in Europe

Boehringer’s Pradaxa gains added indication in Europe

06-06-2014

German family-owned pharma major Boehringer Ingelheim said today that its blood thinner Pradaxa (dabigatran…

Boehringer IngelheimCardio-vascularEuropePharmaceuticalPradaxaRegulation

EMA accepts Boehringer’s accelerated marketing application for nintedanib in IPF

EMA accepts Boehringer’s accelerated marketing application for nintedanib in IPF

05-06-2014

German family-owned pharma major Boehringer Ingelheim said this morning that the European Medicines Agency…

Boehringer IngelheimEuropenintedanibPharmaceuticalRegulationRespiratory and Pulmonary

Boehringer resolves FDA manufacturing facility concerns

Boehringer resolves FDA manufacturing facility concerns

03-06-2014

German family-owned pharma major Boehringer Ingelheim said today that it has been notified by a letter…

Boehringer IngelheimFood and Drug AdministrationGermanyPharmaceuticalPharmaceutical sciencesProductionRegulationResearchUSA

Boehringer and Lilly’s diabetes drug Jardiance gains EU approval

23-05-2014

German family-owned pharma major Boehringer Ingelheim and US partner Eli Lilly have received Marketing…

Boehringer IngelheimDiabetesEli LillyempagliflozinEuropeJardiancePharmaceuticalRegulation

FDA finds favorable risk:benefit balance for Boehringer’s Pradaxa

18-05-2014

As part of its ongoing review, the US Food and Drug Administration last week released latest findings…

Boehringer IngelheimCardio-vascularPharmaceuticalPradaxaRegulationUSA

UK NICE recommends Giotrif and Velcade, but says “no” to added use of Alimta

23-04-2014

People in England and Wales with lung cancer whose tumors test positive for a mutation will now have…

AlimtaBoehringer IngelheimEli LillyGiotrifJohnson & JohnsonNorthern EuropeOncologyPharmaceuticalPricingRegulationUKVelcade

NDA filing for empagliflozin and linagliptin combo accepted by FDA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

14-04-2014

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational…

Boehringer IngelheimDiabetesEli LillyempagliflozinJardiancelinagliptinNorth AmericaPharmaceuticalRegulationTradjentaUSA

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

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

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

EMA/CHMP recommends empagliflozin for approval for type 2 diabetes

23-03-2014

German family-owned drug major Boehringer Ingelheim and partner Eli Lilly of the USA have announce a…

Boehringer IngelheimDiabetesEli LillyempagliflozinEuropeJardiancePharmaceuticalRegulation

NICE draft guidance recommends Boehringer Ingelheim’s Giotrif

NICE draft guidance recommends Boehringer Ingelheim’s Giotrif

17-03-2014

UK drugs watchdog the National Institute for Health and care Excellence (NICE) this morning issued new…

Boehringer IngelheimGiotrifNorthern EuropeOncologyPharmaceuticalPricingRegulationUK

Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

06-03-2014

German family-owned pharma major Boehringer Ingelheim announced positive results from STARTVerso 4 in…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

05-03-2014

There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer…

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

IQWiG finds that added benefit of Boehringer’s Giotrif depends on mutation status

IQWiG finds that added benefit of Boehringer’s Giotrif depends on mutation status

19-02-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG), in an early benefit assessment…

Boehringer IngelheimGermanyGiotrifNorthern EuropeOncologyPharmaceuticalPricingRegulation

EMA accelerated assessment for Boehringer hep C candidate faldaprevir

EMA accelerated assessment for Boehringer hep C candidate faldaprevir

27-11-2013

Family-owned German drug major Boehringer Ingelheim says that its application for European marketing…

Anti-viralsBoehringer IngelheimEuropefaldaprevirPharmaceuticalRegulation

Boehringer Ingelheim files for expanded EU indication for Respimat

Boehringer Ingelheim files for expanded EU indication for Respimat

13-11-2013

German independent drug major Boehringer Ingelheim has submitted an applications to extend the indication…

Boehringer IngelheimEuropePharmaceuticalRegulationRespimatRespiratory and PulmonarySpiriva

Boehringer files for EU approval of nintedanib

Boehringer files for EU approval of nintedanib

15-10-2013

Boehringer Ingelheim has submitted a Marketing Authorization Application to the EMA for the approval…

Boehringer IngelheimEuropenintedanibOncologyPharmaceuticalRegulation

Boehringer Ingelheim gets Breakthrough designation for leukemia candidate

17-09-2013

German pharma major Boehringer Ingelheim has gained Breakthrough Therapy Designation from the US Food…

Boehringer IngelheimEuropeOncologyPharmaceuticalRegulationvolasertib

Pradaxa sNDA for DVT and PE accepted by FDA

28-08-2013

The US Food and Drug Administration has accepted for review German independent drug major Boehringer…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

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