Bayer HealthCare : FDA Grants Orphan Drug Status to Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis

March 11, 2010 – Bayer Schering Pharma AG, Germany, announced that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for the ciprofloxacin dry powder inhaler (DPI) for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency (EMA)... Bayer HealthCare's Press Release -

Bayer Schering Pharma : Progress in Clinical Program for Riociguat

October 6, 2008 – Based on positive Phase II trial findings, Bayer Schering Pharma will move into Phase III trials with its oral agent riociguat (BAY 63-2521). Riociguat is the first member of a new class of vasodilating agents called soluble guanylate cyclase (sGC) stimulators. It is being investigated as a new approach for the treatment of different forms of pulmonary hypertension. Riociguat demonstrated significantly improved exercise capacity in a Phase II study in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) as compared to baseline values. The Phase III program for these indications is planned to be initiated in late 2008... Bayer Schering Pharma's Press Release -