Pharmaceutical - Pharmaceutical, North America, Boehringer Ingelheim

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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

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

Novel oral anticoagulants will continue to drive atrial fibrillation drug market growth

20-12-2013

The atrial fibrillation drug market will experience continued growth through the rest of the decade,…

Asia-PacificBayerBoehringer IngelheimBristol-Myers SquibbCardio-vascularEliquisEuropeMarkets & MarketingNorth AmericaPfizerPharmaceuticalPradaxaXarelto

Trajenta studies prove efficacy in broad range of diabetes patients

Trajenta studies prove efficacy in broad range of diabetes patients

07-11-2013

Boehringer Ingelheim and Eli Lilly (NYSE: LLY) have released new data that reinforces the efficacy and…

Asia-PacificBoehringer IngelheimDiabetesEli LillyNorth AmericaPharmaceuticalResearchTrajentaUSA

Type 2 diabetes market to reach $38.8 billion by 2019

25-10-2013

The global type 2 diabetes market is expected to expand from $20.4 billion in 2012 to $38.8 billion by…

Boehringer IngelheimDiabetesEli LillyEuropeGemigliptinMarkets & MarketingNesinaNorth AmericaPharmaceuticalTakeda PharmaceuticalsTradjenta

Boehringer’s US injectables to cease production

Boehringer’s US injectables to cease production

07-10-2013

Ben Venue Laboratories, a subsidiary of Boehringer Ingelheim, has decided to cease production by the…

Ben Venue LabsBoehringer IngelheimNorth AmericaPharmaceuticalProduction

Global type 2 diabetes market to reach $38.8 billion by 2019

25-09-2013

The global type 2 diabetes market is expected to grow from $20.4 billion in 2012 to $38.8 billion by…

Boehringer IngelheimDiabetesEli LillyEuropeGemigliptinLG Life SciencesMarkets & MarketingNesinaNorth AmericaPharmaceuticalTakeda PharmaceuticalsTradjenta

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

Gilotrif to debut in the USA in week starting Sept 2

23-08-2013

The US subsidiary of family-owned German drug major Boehringer Ingelheim says that, following last month's…

Boehringer IngelheimGilotrifMarkets & MarketingNorth AmericaOncologyPharmaceutical

US FDA approves Boehringer Ingelheim's first cancer drug

15-07-2013

In what the family-owned German drug major Boehringer Ingelheim hopes is just the first drug to come…

afatinibBiotechnologyBoehringer IngelheimGilotrifNorth AmericaOncologyPharmaceuticalQiagenRegulation

Briefs: Boehringer files Pradaxa for DVT and PE; Astellas' Mycamine pediatric approval; Simcere divests Boda

25-06-2013

Family-owned German drug major Boehringer Ingelheim has submitted an application to the European Medicines…

Antibiotics and Infectious diseasesAstellas PharmaBoehringer IngelheimCardio-vascularEuropeJilin BodaMergers & AcquisitionsNorth AmericaPharmaceuticalRegulationSimcere PharmaceuticalYidashen

FDA approves Boehringer and Lilly's Tradjenta and Jentadueto labeling to reflect pancreatitis risk

21-06-2013

German family-owned Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY) revealed yesterday (June…

Boehringer IngelheimDiabetesEli LillyJentaduetoNorth AmericaPharmaceuticalRegulationTradjenta

SOBI gets FDA approval to manufacture substance for Kineret with partner Boehringer Ingelheim

11-06-2013

Swedish Orphan Biovitrum (STO: SOBI) said today (June 11) that it has received approval from the US Food…

Boehringer IngelheimInflammatory diseasesKineretNorth AmericaPharmaceuticalProductionRegulationSavient PharmaceuticalsSwedish Orphan Biovitrum

Gilead gains FDA priority review for hep C candidate sofosbuvir; new data on Boehringer's faldaprevir

10-06-2013

US biotech firm Gilead Sciences (Nasdaq: GILD) revealed on Friday (June 7) that the US Food and Drug…

Anti-viralsAsia-PacificBiotechnologyBoehringer IngelheimfaldaprevirGilead SciencesNorth AmericaPharmaceuticalRegulationResearchsofosbuvir

US FDA approves companion diagnostic for Tarceva, and new indication for the Roche drug

15-05-2013

The US Food and Drug Administration late yesterday (May 14) approved Swiss drug major Roche (ROG: SIX)…

Boehringer IngelheimNorth AmericaOncologyPharmaceuticalQiagenRegulationRocheTarcevaTomtovok

Surveys reveal opportunity for medical community to fully embrace biomarker testing in lung cancer

07-05-2013

Results of two surveys that explored how pulmonologists and pathologists are incorporating biomarker…

Boehringer IngelheimNorth AmericaOncologyPharmaceuticalResearch

Regulatory briefs on Bayer's Stivarga, Boehringer/Lilly's empagliflozin and Pfizer's Xeljanz

26-03-2013

Drug regulator Health Canada has approved German drug major Bayer's Stivarga (regorafenib tablets), indicated…

Anti-Arthritics/RheumaticsAsia-PacificBayerBiotechnologyBoehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaOncologyPfizerPharmaceuticalRegulationStivargaXeljanz

FDA confirms views that Boehringer's Pradaxa bleeding rates no higher than for warfarin

19-03-2013

A new perspective from the US Food and Drug Administration states the agency has not changed its recommendations…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaResearch

FDA probes possible higher risk of pancreatitis for newer type 2 diabetes drugs

15-03-2013

The US Food and Drug Administration revealed in a web posting yesterday that it is evaluating unpublished…

Boehringer IngelheimBristol-Myers SquibbDiabetesEli LillyExenatide InjectionlinagliptinMerck & CoNorth AmericaNovo NordiskPharmaceuticalRegulationsaxagliptinsitagliptinVictoza

FDA advisory panel backs Boehringer's COPD drug olodaterol

30-01-2013

In a 15 to one vote with one abstension, the US Food and Drug Administration's Pulmonary-Allergy Drugs…

Boehringer IngelheimNorth AmericaolodaterolPharmaceuticalRegulationRespiratory and PulmonaryStriverdi Respimat

Boehringer Ingelheim's afatinib NDA gets priority review in USA

16-01-2013

The US subsidiary of German independent drug major Boehringer Ingelheim revealed yesterday that the New…

afatinibBoehringer IngelheimNorth AmericaOncologyPharmaceuticalQiagenRegulationTomtovok

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

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

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