Regulation - Boehringer Ingelheim, Cardio-vascular

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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…

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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

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

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

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

Boehringer Ingelheim updates safety info for Pradaxa related to heart valve

21-12-2012

The US subsidiary of German independent drug major Boehringer Ingelheim says that the US prescribing…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

Australian review finds more work needed on new anticoagulants

19-12-2012

A report into anticoagulation therapies released yesterday by Australian Minister for Health Tanya Plibersek…

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Serious bleeding risk with Boehringer's Pradaxa no worse than warfarin, says FDA

06-11-2012

In a follow up to a 2011 safety communication, the US Food and Drug Administration has evaluated new…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationResearch

NICE final guidance backs NHS use of Boehringer Ingelheim's Actilyse

25-09-2012

In final guidance issued this morning (September 26), UK drugs watchdog the National Institute for Health…

ActilyseBoehringer IngelheimCardio-vascularEuropePharmaceuticalPricingRegulation

NICE issues draft guidance on Boehringer's Actilyse

27-08-2012

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) issued draft guidance…

ActilyseBoehringer IngelheimCardio-vascularEuropePharmaceuticalRegulation

Boehringer Ingelheim updates US labelling of Pradaxa for stroke

07-06-2012

Independent German drug major Boehringer Ingelheim has updated the US prescribing information for Pradaxa…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

EMA unit backs approval of Jentadueto; Agency updates on Pradaxa

28-05-2012

Independent German drug major Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY) have received…

Boehringer IngelheimCardio-vascularDiabetesEli LillyEuropeJentaduetoPharmaceuticalPradaxaRegulation

NICE recommends NHS use of Pradaxa

15-03-2012

In final guidance published today (March 15), the UK drug watchdog the National Institute of Health and…

Boehringer IngelheimCardio-vascularEuropePharmaceuticalPradaxaPricingRegulation

FDA reviews Pradaxa bleeding risk

08-12-2011

Post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate),…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

EMA says bleeding risks associated with Boehringer Ingelheim’s Pradaxa can be managed

20-11-2011

The European Medicines Agency on Friday providing an update on the safety of independent German drug…

Boehringer IngelheimCardio-vascularEuropePharmaceuticalPradaxaRegulation

UK NICE recommends Boehringer’s Pradaxa for stroke prevention

01-11-2011

In final draft guidance published today (November 1), the UK’s drug watchdog the National Institute…

Boehringer IngelheimCardio-vascularEuropePharmaceuticalPradaxaPricingRegulation

EU approves Boehringer’s Pradaxa for stroke prevention in atrial fibrillation

05-08-2011

There was good news for independent German drug major Boehringer Ingelheim yesterday, when the company…

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