Literature DB >> 31655357

Revocation of the conditional marketing authorisation of a cancer medicine: The olaratumab experience.

Ralf Herold1, Jorge Camarero2, Daniela Melchiorri3, Zigmars Sebris4, Harald Enzmann5, Francesco Pignatti6.   

Abstract

Entities:  

Keywords:  Clinical trials; Drug development; Marketing authorisation; Regulation; Sarcoma

Mesh：

Substances：

Year:  2019        PMID： 31655357     DOI： 10.1016/j.ejca.2019.09.020

Source DB:  PubMed          Journal:  Eur J Cancer        ISSN： 0959-8049            Impact factor:   9.162


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  3 in total

1.  Implementing Historical Controls in Oncology Trials.

Authors:  Olivier Collignon; Anna Schritz; Riccardo Spezia; Stephen J Senn
Journal:  Oncologist       Date:  2021-03-06

Review 2.  WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations.

Authors:  Jerome Amir Singh; Sonali Kochhar; Jonathan Wolff; Caesar Atuire; Anant Bhan; Ezekiel Emanuel; Ruth Faden; Prakash Ghimire; Dirceu Greco; Calvin Ho; Suerie Moon; Ehsan Shamsi-Gooshki; Aissatou Touré; Beatriz Thomé; Maxwell J Smith; Ross E G Upshur
Journal:  Vaccine       Date:  2022-02-28       Impact factor: 3.641

3.  Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: A comparison with standard approved cancer drugs.

Authors:  Lourens T Bloem; Rosa E Bot; Aukje K Mantel-Teeuwisse; Menno E van der Elst; Gabe S Sonke; Olaf H Klungel; Hubert G M Leufkens; Jarno Hoekman
Journal:  Br J Clin Pharmacol       Date:  2022-01-05       Impact factor: 3.716
  3 in total

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