Blog
RSS FeedPosted by Michael Wonder on 10 Jul 2022
Human genetics evidence supports two-thirds of the 2021 FDA approved drugs
8 July 2022 - In 2021, 50 drugs were approved by the FDA’s Center for Drug Evaluation and Research, continuing a ...
Posted by Michael Wonder on 30 Mar 2022
FDA officials aim to stop misuse of the term ‘digital biomarker’
29 March 2022 - While a lot of researchers claim they are capturing digital biomarker data, they may in fact be ...
Posted by Michael Wonder on 24 Jul 2019
FDA seeks input on biomarker, endpoint glossary
24 July 2019 - Two-and-a-half years after its release, the US FDA is asking for input from the public on ...
Posted by Michael Wonder on 28 Aug 2018
Pfizer calls for FDA guidance to address false and misleading biosimilar advertisements
28 August 2018 - Taking issue with Amgen, Genentech and other reference product sponsors’ dissemination of misleading information on biosimilars, ...
Posted by Michael Wonder on 12 Oct 2017
First FDA approval agnostic of cancer site — when a biomarker defines the indication
11 October 2017 - In May 2017, the FDA approved pembrolizumab, a programmed death 1 inhibitor, for adult and paediatric patients ...
Posted by Michael Wonder on 15 Feb 2017
Europe ready to embrace first copies of biotech cancer drugs
15 February 2017 - Treatment with two important cancer drugs is about to get much cheaper in Europe with a ...
Posted by Michael Wonder on 16 Mar 2016
Biomarkers and surrogate endpoints
16 March 2016 - This Viewpoint describes the rationale behind an FDA and NIH effort to develop a glossary of common ...
Posted by Michael Wonder on 09 Dec 2015
CADTH releases report on cancer biomarker testing
9 December 2015 - The final environmental ccan report is now available for the CADTH project on cancer biomarker testing. ...