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Boehringer Ingelheim

FDA accepts filing of cardiovascular outcomes for Jardiance

26 January 2016 | By Victoria White

The FDA has accepted a sNDA for Jardiance (empagliflozin) based on cardiovascular risk reduction data from the EMPA-REG OUTCOME trial...

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Benefit-risk profile of ambroxol and bromhexine medicines confirmed by EC

22 January 2016 | By Victoria White

The decision includes an update of the product information of all ambroxol and bromhexine containing products to include the rare risk of hypersensitivity reactions and a Precaution and Warning regarding severe cutaneous adverse reactions...

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Boehringer Ingelheim to open new biopharmaceutical facility in Vienna

22 December 2015 | By Victoria White

The facility will produce ingredients manufactured using cell cultures and will create more than 400 new jobs in the Austrian capital...

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FDA grants Breakthrough designation for BI 1482694 in lung cancer

21 December 2015 | By Victoria White

BI 1482694 is Boehringer Ingelheim’s 3rd-generation, epidermal growth factor receptor mutation-specific tyrosine kinase inhibitor...

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Sanofi and Boehringer Ingelheim announce business swap

15 December 2015 | By Victoria White

The proposed transaction would consist of an exchange of Sanofi animal health business (Merial) and Boehringer Ingelheim consumer healthcare (CHC) business...

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Trial of Ofev and pirfenidone in IPF starts

14 December 2015 | By Victoria White

The trial’s primary endpoint is the percentage of patients with on-treatment gastrointestinal adverse events from baseline to week 12...

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EC approves anticoagulant reversal agent idarucizumab

26 November 2015 | By Victoria White

Idarucizumab (Praxbind) rapidly and specifically reverses the anticoagulant effects of dabigatran etexilate (Pradaxa) in cases of emergency surgery /urgent procedures or in uncontrolled bleeding...

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New analyses add to efficacy and safety profile of Ofev in IPF

13 November 2015 | By Victoria White

A post-marketing surveillance study showed that treatment with Ofev in the real-world clinical setting had a safety profile consistent with that observed in clinical trials...

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Boehringer Ingelheim initiates Phase II trial of BI 1482694 in NSCLC

3 November 2015 | By Victoria White

BI 1482694 is a novel, third-generation, oral, irreversible EGFR mutant-specific tyrosine kinase inhibitor (TKI) developed to specifically target tumours with T790M mutations...

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Boehringer Ingelheim announces data for Spiolto Respimat and biosimilar candidate

28 October 2015 | By Victoria White

Boehringer Ingelheim today announced new data from post-hoc analyses of studies of Spiolto Respimat and a Phase I trial of its adalimumab biosimilar candidate...

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FDA approves Boehringer Ingelheim’s Praxbind

19 October 2015 | By Victoria White

Praxbind is indicated for patients treated with Pradaxa, when reversal of the anticoagulant effects of Pradaxa is needed for emergency surgery or in uncontrolled bleeding...

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BI 655066 cleared skin better than ustekinumab in psoriasis study

8 October 2015 | By Victoria White

Boehringer Ingelheim has reported new results from a Phase II head-to-head psoriasis study that showed superior efficacy of the company’s biologic compound BI 655066 over ustekinumab...

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New data demonstrates long-term efficacy of Ofev in IPF

30 September 2015 | By Victoria White

The results confirm that Ofev has a long-term effect on slowing IPF disease progression and has a manageable side effect profile...

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CHMP issues positive opinion for idarucizumab, the reversal agent for dabigatran

25 September 2015 | By Victoria White

Idarucizumab is intended for use in patients treated with dabigatran who require immediate anticoagulant reversal prior to urgent procedures or in case of uncontrolled bleeding...

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Successful Phase 1 results for cardiometabolic disease drug PXS-4728A

22 September 2015 | By Victoria White

PXS-4728A is a highly selective inhibitor of an enzyme and adhesion protein which reduces inflammation and oxidative stress...

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