Brief: Paratek Withdraws European Marketing Authorization Application For Oral And Intravenous NUZYRA In Skin Infections & Pneumonia
17/10/2019 22:07
Oct 17 (Reuters) - Paratek Pharmaceuticals Inc PRTK.O :
* PARATEK WITHDRAWS EUROPEAN MARKETING AUTHORIZATION
APPLICATION
FOR ORAL AND INTRAVENOUS NUZYRA IN SKIN INFECTIONS AND PNEUMONIA
* PARATEK PHARMACEUTICALS INC - EMA REQUESTING SECOND STUDY
IN
CABP TO MEET REGULATORY STANDARDS OF TWO PHASE 3 STUDIES
* PARATEK - PLANS TO RE-SUBMIT APPLICATION TO EMA FOLLOWING
COMPLETION OF PLANNED POST-MARKETING APPROVAL CABP STUDY ALREADY
AGREED WITH FDA
* PARATEK PHARMACEUTICALS INC - APPLICATION APPROVABLE BY
EUROPEAN
MEDICINE AGENCY (EMA) FOR SKIN INFECTIONS BASED ON TWO PHASE 3
STUDIES
Source text for Eikon: ID:nGNX8bDqg5
Further company coverage: PRTK.O
(Reuters.Briefs@thomsonreuters.com)
Recent news on Paratek Pharmaceuticals
See all newsNovo Holdings closes $462 mln acquisition of Paratek Pharmaceuticals
Brief: Glass Lewis Recommends Paratek Pharmaceuticals Stockholders Vote For Acquisition By Gurnet Point Capital And Novo Holdings
Brief: Paratek Pharmaceuticals Responds to Demand Letters From 11 Stockholders Alleging 'Misleading', Incomplete Statements In Proxy Statement Filed On June 30
Brief: Independent Proxy Advisory Firm ISS Recommends Paratek Pharmaceuticals Stockholders Vote For Acquisition By Gurnet Point Capital And Novo Holdings
Brief: Paratek Pharmaceuticals Announces Second Quarter 2023 Revenue Of $40.0 Million