Blog
RSS FeedPosted by Michael Wonder on 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...
Posted by Michael Wonder on 28 Sep 2023
The use of historical controls in clinical trials
28 September 2023 - A randomised clinical trial is frequently the preferred research design for testing new medical treatments. Randomisation helps ...
Posted by Michael Wonder on 03 Nov 2020
Regulatory policy may not stop comparative efficacy trials
4 November 2020 - The way Sarfaraz K. Niazi, looks at it, doing comparative efficacy studies in humans to confirm that ...
Posted by Michael Wonder on 08 Oct 2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved ...
Posted by Michael Wonder on 15 Sep 2020
FDA publishes comparative performance data for COVID-19 molecular diagnostic tests
15 September 2020 - Today, the U.S. FDA published comparative performance data for some authorised COVID-19 molecular diagnostic tests. ...
Posted by Michael Wonder on 05 Sep 2020
Biocon, Mylan launch Semglee and seek biosimilar, interchangeable status
31 August 2020 - For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to ...
Posted by Michael Wonder on 19 Dec 2018
Comparative assessment of clinical benefit using the ESMO Magnitude of Clinical Benefit Scale version 1.1 and the ASCO Value Framework Net Health Benefit Score
19 December 2018 - To better understand the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) ...
Posted by Michael Wonder on 21 Aug 2018
FDA analysis shows similar success rates for paediatric trials using clinical and surrogate outcomes
21 August 2018 - An analysis by US FDA officials published earlier this month finds that there is a similar ...
Posted by Michael Wonder on 17 Jul 2018
Are 'breakthrough' drugs as safe as other FDA approved medicines?
17 July 2018 - New research questions the quality of drugs given the "breakthrough therapy" designation by the US FDA. ...
Posted by Michael Wonder on 03 May 2018
How the U.S. compares to Europe on biosimilar approvals and products in the pipeline
2 May 2018 - FDA has not approved any biosimilar drug in 2018. ...
Posted by Michael Wonder on 24 Jan 2018
Characteristics of interim publications of randomised clinical trials and comparison with final publications
23 January 2018 - Publication of interim results of randomised trials can be consequential, potentially undermining trial integrity by unblinding or ...
Posted by Michael Wonder on 26 Oct 2017
New shingles vaccine endorsed over competitor by expert panel, a boost for GSK
25 October 2017 - The expert panel that helps guide U.S. vaccination policy has voted to give a preferential recommendation ...
Posted by Michael Wonder on 10 Oct 2017
Gatekeeping strategies for avoiding false-positive results in clinical trials with many comparisons
10 October 2017 - Clinical trials characterizing the effects of an experimental therapy rarely have only a single outcome of interest. ...
Posted by Michael Wonder on 27 Jul 2017
Challenges in international comparison of health care systems
27 July 2017 - International comparisons of health system performance exert major influence on the public and on policy makers. ...
Posted by Michael Wonder on 07 Sep 2016
Generic drug approvals since the 1984 Hatch-Waxman Act
6 September 2016 - This study, published in JAMA, uses US FDA data to identify approved generic drugs manufactured between September ...