US FDA gives Fast Track designation to Boehringer Ingelheim’s nintedanib

Boehringer Ingelheim announces the FDA has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). The FDA’s Fast Track designation enables development of new therapies that treat serious conditions and fulfil an unmet medical need in an effort to get treatments to those in need sooner.

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Boehringer gains first biosimilar approval within EU for Cyltezo

Boehringer Ingelheim has recently won its first biosimilar approval in Europe with authorisation of Cyltezo for a variety of chronic inflammatory conditions, which includes rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Cyltezo is a biosimilar of AbbVie’s Humira, an anti-TNF monoclonal antibody that pulls in annual sales of approximately $15 billion across its

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Scottish Medicines Consortium Recommends Boehringer’s Trajenta

The Scottish Medicines Consortium (SMC) have issued final advice recommending the approval of Boehringer Ingelheim’s Trajenta with insulin to treat adults with type 2 diabetes to improve glycaemic control. The recommendation follows a Health Technology Appraisal accepting Trajenta (linagliptin) for treatment in combination with insulin with or without metformin, when insulin alone, with diet and

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European Commission Grants Boehringer’s Vargatef Regulatory Approval

Boehringher Ingelheim announced yesterday that the European Commission has granted marketing authorisation for their Vargatef (nintedanib).  Vargatef is a triple angiokinase inhibitor for the treatment of lung cancer patients. The drug has been approved when used in combination with docetaxel for adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC)

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European Regulatory Approval for Eli Lilly / Boehringer’s Abasria

The European Commission has granted regulatory approval to Eli Lilly and Boehringer Ingelheim’s Abasria for treating diabetes in adults, adolescents and children aged two years and above. The approval follows EMA’s Committee for Medicinal Products for Human Use (CHMP) positive recommendation earlier this year. The previous recommendation noted that clinical studies of the insulin showed

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Scotland Approves Novartis / ThromboGenics’ Jetrea and Roche’s RoActemra

The Scottish Medicines Consortium (SMC) has announced their latest set of recommendations approving regulatory submissions for Novartis and ThromboGenics’ eye therapy Jetrea and Roche’s RoActemra. The SMC have also announced rejections for the chronic obstructive pulmonary disease (COPD) drugs submitted for approval by Boehringer Ingelheim and GlaxoSmithKline (GSK).

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