Basilea's partner Astellas receives notification from U.S. FDA of acceptance of filing of isavuconazole NDA for the treatment of invasive aspergillosis and invasive mucormycosis
GlobeNewswire - Sat Sep 06, 7:22AM CDT
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today 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. The NDA seeks approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis) in adults. 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.
Extensive data presented on Basilea's anti-infectives isavuconazole, ceftobiprole and BAL30072 at ICAAC
GlobeNewswire - Fri Sep 05, 12:19AM CDT
Basilea Pharmaceutica Ltd. (SIX: BSLN) announces today that extensive data will be presented on the anti-fungal isavuconazole and the antibiotics ceftobiprole and BAL30072 at the 54 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 5-9, 2014 in Washington, DC (USA).
European Medicines Agency accepts Basilea's isavuconazole Marketing Authorization Application for review
GlobeNewswire - Thu Aug 21, 12:20AM CDT
Basilea Pharmaceutica Ltd. (SIX: BSLN) announces today that the European Medicines Agency (EMA) has accepted its isavuconazole Marketing Authorization Application (MAA) for review. Basilea's MAA seeks approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis (zygomycosis) in adults.
Basilea appoints Chief Commercial Officer
GlobeNewswire - Mon Aug 18, 12:21AM CDT
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that it has appointed David Veitch as Chief Commercial Officer of Basilea Pharmaceutica International Ltd. Mr Veitch will join the company on September 1, 2014. As a member of the management committee, he will be responsible for leading Basilea's commercial operations, including sales, marketing, pricing and market access, reporting to Chief Executive Officer Ronald Scott.
Basilea reports 2014 half-year financials - ceftobiprole launch in Germany planned for second half of 2014
Thomson Reuters ONE - Thu Aug 14, 12:16AM CDT
Basilea Pharmaceutica AG / Basilea reports 2014 half-year financials - ceftobiprole launch in Germany planned for second half of 2014 . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.
Dotmatics Announce Speaker Line-up for User Group Meeting 2014
PR Newswire Europe - Wed Jul 23, 8:59AM CDT
BISHOPS STORTFORD, England, July 23, 2014 /PRNewswire/ --
Basilea to introduce the antibiotic ceftobiprole medocaril in Europe through Quintiles
M2 - Mon Jul 21, 7:59AM CDT
Pharmaceutical products company Basilea Pharmaceutica (Munich
Basilea to launch Zevtera(r)/Mabelio(r) (ceftobiprole medocaril) in Europe through a commercial services provider
GlobeNewswire - Mon Jul 21, 12:23AM CDT
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports that it has entered into an agreement with Quintiles (NYSE: Q) for the commercialization of Zevtera(R)/Mabelio(R) (ceftobiprole medocaril) in Europe.
Basilea submits isavuconazole European Marketing Authorization Application for the treatment of invasive mold infections
Thomson Reuters ONE - Thu Jul 17, 1:46AM CDT
Basilea Pharmaceutica AG / Basilea submits isavuconazole European Marketing Authorization Application for the treatment of invasive mold infections . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.
Basilea reports that isavuconazole received QIDP designation from U.S. FDA for the treatment of invasive candidiasis
Thomson Reuters ONE - Thu Jul 17, 1:45AM CDT
Basilea Pharmaceutica AG / Basilea reports that isavuconazole received QIDP designation from U.S. FDA for the treatment of invasive candidiasis . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.
Basilea reports that isavuconazole receives orphan drug designations in Europe for the treatment of invasive mold infections
GlobeNewswire - Mon Jul 14, 2:14AM CDT
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the European Commission granted isavuconazole orphan drug designations for the treatment of invasive aspergillosis and mucormycosis (zygomycosis). Isavuconazole is an investigational intravenous and oral broad-spectrum antifungal.