Brief: Basilea Provides Update On New Drug Application To The US FDA For Antibiotic Ceftobiprole

Basilea Pharmaceutica AG, Allschwil

18/04/2023 06:20

April 18 (Reuters) - Basilea Pharmaceutica Ag  BSLN.S :
    * BASILEA PROVIDES UPDATE ON NEW DRUG APPLICATION TO THE US
FOOD
AND DRUG ADMINISTRATION FOR ANTIBIOTIC CEFTOBIPROLE
    * BASILEA PHARMACEUTICA - ADDITIONAL 3 TO 6 MONTHS OF WORK
REQUIRED TO ENSURE ONE OF THIRD-PARTY CONTRACT MANUFACTURING
ORGS IS READY FOR FDA INSPECTION
    * UPDATED TIMELINES FOR NDA SUBMISSION IN US DO NOT HAVE ANY
IMPACT ON BASILEA'S FINANCIAL GUIDANCE
    * BASILEA-TO SUBMIT NDA FOR STAPHYLOCOCCUS AUREUS BACTEREMIA
,
ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS,
COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA IN Q3

Source text for Eikon:  ID:nGNX9zW3g8 
Further company coverage:  BSLN.S 

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