Key Developments: Basilea Pharmaceutica AG (BSLN.S)

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Latest Key Developments (Source: Significant Developments)

Basilea Pharmaceutica in-licenses targeted cancer therapy
Wednesday, 1 Apr 2015 01:15am EDT 

Basilea Pharmaceutica AG:Entered into license agreement for novel panRAF kinase inhibitors with consortium of organizations including Institute Of Cancer Research, London, Cancer Research Technology, Wellcome Trust and University Of Manchester.  Full Article

Basilea Pharmaceutica reports U.S. FDA approval of isavuconazole for treatment of invasive aspergillosis and invasive mucormycosis
Friday, 6 Mar 2015 05:13pm EST 

Basilea Pharmaceutica:Announced that the FDA approved Astellas' New Drug Application (NDA) for the use of isavuconazole for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.  Full Article

Basilea Pharmaceutica AG comments on FY 2015 outlook
Tuesday, 17 Feb 2015 01:15am EST 

Basilea Pharmaceutica AG:Total operating expenses for FY 2015 are estimated at approx. 9 million francs on average per month.Average operating loss in FY 2015 is estimated at approx. 4 million francs per month.  Full Article

Basilea Pharmaceutica AG announces that FDA's anti-infective drugs advisory committee recommends approval of isavuconazole
Thursday, 22 Jan 2015 03:12pm EST 

Basilea Pharmaceutica AG:Says FDA's Anti-Infective Drugs Advisory Committee voted unanimously to recommend approval of the investigational once-daily intravenous and oral antifungal isavuconazole, the active moiety of the prodrug isavuconazonium sulfate.Says it is for the treatment of invasive aspergillosis, and eight to two with one abstention to recommend approval for the treatment of invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients.  Full Article

Basilea Pharmaceutica AG says Swissmedic approves Zevtera
Monday, 22 Dec 2014 01:15am EST 

Basilea Pharmaceutica AG:Says Swissmedic approves Basilea's antibiotic Zevtera (ceftobiprole medocaril) for treatment of pneumonia.Swissmedic approved Zevtera for treatment in adults of community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).  Full Article

Basilea Pharmaceutica announces launch of antibiotic Zevtera (ceftobiprole medocaril) in Germany
Friday, 5 Dec 2014 01:16am EST 

Basilea Pharmaceutica AG:Announces launch of antibiotic Zevtera (ceftobiprole medocaril) in Germany.  Full Article

Basilea Pharmaceutica AG reports granting of U.S. orphan drug designation to isavuconazole for treatment of invasive candidiasis
Monday, 3 Nov 2014 01:18am EST 

Basilea Pharmaceutica AG:Says that the U.S. Food and Drug Administration has granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis/candidemia, a potentially life-threatening infection caused by Candida yeasts.Isavuconazole has previously been granted orphan drug status in the European Union and the U.S. for the treatment of invasive aspergillosis and mucormycosis.  Full Article

Basilea Pharmaceutica AG receives notification from U.S. FDA of acceptance of filing of isavuconazole NDA for the treatment of invasive aspergillosis and invasive mucormycosis
Saturday, 6 Sep 2014 08:22am EDT 

Basilea Pharmaceutica AG:Says that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application for isavuconazole submitted by Basilea's license partner Astellas Pharma Inc.Says the NDA seeks approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis) in adults.Says in accordance with the FDA Prescription Drug User Fee Act (PDUFA), the FDA designated the date of March 8, 2015 for the completion of the review.  Full Article

European Medicines Agency accepts Basilea Pharmaceutica's Isavuconazole marketing authorization application for review
Thursday, 21 Aug 2014 01:16am EDT 

Basilea Pharmaceutica AG:Says European Medicines Agency accepts Isavuconazole marketing authorization application for review.Seeks approval of Isavuconazole for treatment of invasive aspergillosis and mucormycosis (zygomycosis) in adults.  Full Article

Basilea Pharmaceutica AG confirms FY 2014 guidance
Thursday, 14 Aug 2014 01:25am EDT 

Basilea Pharmaceutica AG:Confirms its unchanged guidance.Total operating expenses for 2014 are estimated at 8 to 9 million Swiss francs on average per month.The operating loss in 2014 is estimated at 4 to 5 million Swiss francs on average per month.  Full Article

BRIEF-Basilea Pharmaceutica reports start of first-in-human phase 1 oncology study with oral panRAF kinase inhibitor

* Said on Monday it reported start of first-in-human phase 1 oncology study with oral panRAF kinase inhibitor

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