Key Developments: Basilea Pharmaceutica AG (BSLN.S)

BSLN.S on Swiss Exchange

91.75CHF
23 Dec 2014
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Latest Key Developments (Source: Significant Developments)

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

Basilea Pharmaceutica AG to launch Zevtera/Mabelio (ceftobiprole medocaril) in Europe through Quintiles
Monday, 21 Jul 2014 01:16am EDT 

Basilea Pharmaceutica AG:Reports that it has entered into an agreement with Quintiles for the commercialization of Zevtera/Mabelio (ceftobiprole medocaril) in Europe.Says under the agreement, Quintiles will provide commercial services including a dedicated field force, medical science liaisons, and market access support in selected countries.  Full Article

Basilea Pharmaceutica AG submits isavuconazole European Marketing Authorization Application for the treatment of invasive mold infections
Thursday, 17 Jul 2014 01:20am EDT 

Basilea Pharmaceutica AG:Says that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis (zygomycosis).Says Basilea's co-development partner Astellas Pharma Inc. also recently submitted a New Drug Application (NDA) for isavuconazole to the U.S. Food and Drug Administration (FDA).  Full Article

Basilea Pharmaceutica AG announces isavuconazole received QIDP designation from U.S. FDA
Wednesday, 16 Jul 2014 12:11pm EDT 

Basilea Pharmaceutica AG:Says that U.S. Food and Drug Administration (FDA) designated isavuconazole as Qualified Infectious Disease Product (QIDP) for oral and intravenous treatment of invasive candidiasis, a life-threatening invasive fungal infection caused by Candida yeasts.QIDP designation, granted under U.S. GAIN Act, provides priority review and five-year extension of market exclusivity, should product be approved in United States.Isavuconazole was previously granted QIDP designation for treatment of invasive aspergillosis and invasive mucormycosis which are severe mold infections.In addition, isavuconazole FDA fast-track status and received U.S. and European Union orphan drug designations for invasive aspergillosis and mucormycosis.  Full Article

Basilea Pharmaceutica AG Isavuconazole receives orphan drug designations in Europe
Monday, 14 Jul 2014 01:15am EDT 

Basilea Pharmaceutica AG:Says Isavuconazole receives orphan drug designations in Europe for treatment of invasive mold infections.  Full Article

BRIEF-Basilea Pharmaceutica says Swissmedic approves Zevtera

* Says Swissmedic approves Basilea's antibiotic Zevtera (ceftobiprole medocaril) for treatment of pneumonia

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