European Commission

June 30, 2017June 30, 2017

New Esbriet Tablets for IPF Treatment Now Available in Europe

The European Commission has approved a new formulation of Esbriet (pirfenidone) tablets for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). Esbriet, developed by Roche, is an oral antifibrotic medication approved ... Read more

February 17, 2017February 17, 2017

European Environmental Federation Hails EU Air-standards Compliance Move

Asthma, Chronic Bronchitis, News

The non-profit European Environmental Bureau (EEB) is hailing a European Commission move toward legal action against France, Germany, Italy, Spain and the United Kingdom for failing to protect their citizens from ... Read more

May 17, 2016May 25, 2016

Actelion’s Uptravi for PAH Granted Marketing Authorization by European Commission

News, Pulmonary Hypertension

The European Commission recently granted marketing authorization in the EU for Switzerland-based Actelion’s product Uptravi (selexipag) for the treatment of pulmonary arterial hypertension. PAH is a life-threatening disease characterized by abnormal constriction of the pulmonary ... Read more

February 5, 2016February 18, 2016

Respiratory Infections in CF Patients Are Focus of Orphan Drug Application in Europe

News

Arch Biopartners recently announced that it filed an application for orphan drug designation to the European Medicines Authority (EMA) for its medicine AB569, developed as a treatment for the bacterium Pseudomonas aeruginosa (P. aeruginosa) that ... Read more

February 2, 2016February 3, 2016

European Medicines Agency Gives Positive Opinion to Uptravi for Long-Term PAH Treatment

News, Pulmonary Hypertension

The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has given a positive opinion to Uptravi (selexipag) for the treatment of pulmonary ... Read more

September 28, 2015September 28, 2015

CHMP Issues Positive Recommendation for ORKAMBI and KALYDECO in the EU

News

Biotechnology company Vertex Pharmaceuticals, Inc. recently announced that the European Union Committee for Medicinal Products for Human Use (CHMP) has released a positive opinion and recommendation for Marketing Authorization of breakthrough ... Read more

July 21, 2015July 21, 2015

European Commission Approves Nivolumab BMS by Bristol-Myers Squibb for NSCLC

Lung Cancer, News

Bristol-Myers Squibb Company recently announced the European Commission has granted approval of Nivolumab BMS as an effective post-chemotherapy treatment for locally advanced or metastatic squamous (SQ) non-small cell lung cancer ... Read more

January 14, 2015January 14, 2015

Lung Therapeutics’ Empyema Drug Receives European Orphan Medicinal Product Status

News, Pneumonia

Pharmaceutical company Lung Therapeutics, Inc. has received the orphan medicinal product designation from the European Commission (EC) for its lead drug candidate LTI-01 for the treatment of empyema, a complication related to pneumonia. The status was ... Read more

December 12, 2014December 12, 2014

Nintedanib by Boehringer Approved in EU as Second-Line NSCLC Treatment

Lung Cancer, News

Drug maker Boehringer Ingelheim has announced that the European Commission granted Vargatef® (nintedanib) marketing approval in 28 EU countries. Together with docetaxel, it is indicated for the post-chemotherapy treatment of either locally ... Read more