Blog
RSS FeedPosted by Michael Wonder on 27 Jul 2024
US FDA approves Leqselvi (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata
25 July 2024 - Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials. ...
Posted by Michael Wonder on 01 Feb 2023
Trastuzumab deruxtecan for treating HER2 positive unresectable or metastatic breast cancer after one or more anti-HER2 treatments
1 February 2023 - Trastuzumab deruxtecan is recommended with managed access as an option for the treatment of adults with HER2 ...
Posted by Michael Wonder on 11 Nov 2021
Health tech questions await next FDA chief
10 November 2021 - Twenty months into the pandemic, the FDA remains consumed with vital decisions on coronavirus vaccines and treatments. ...
Posted by Michael Wonder on 29 Sep 2021
Benefit-risk assessment for new drug and biological products
29 September 2021 - The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about ...
Posted by Michael Wonder on 16 Sep 2021
Raising the bar for using surrogate outcomes in drug regulation and health technology assessment
16 September 2021 - Surrogate outcomes provide no guarantee of clinical benefit, and Dalia Dawoud and colleagues argue they should ...
Posted by Michael Wonder on 04 Dec 2020
ICER opens nominations for new members of its voting panels
2 December 2020 - Independent panel members debate the evidence on the effectiveness and value of new drugs and other ...
Posted by Michael Wonder on 21 Oct 2020
California plans to review coronavirus vaccine independently
19 October 2020 - California is planning to review federally approved coronavirus vaccines independently before distributing it to residents, Governor ...
Posted by Michael Wonder on 06 Oct 2020
Demystifying the estimand framework: a case study using patient-reported outcomes in oncology
1 October 2020 - Patient-reported outcome measures describe how a patient feels or functions and are increasingly being used in benefit–risk ...
Posted by Michael Wonder on 17 Mar 2020
Explaining health state utility assessment
17 March 2020 - Health state utilities are used to provide quantitative measures of how strongly a person values a certain ...
Posted by Michael Wonder on 29 Aug 2019
Academics and consumer groups protest FDA plan to summarise review documents
29 August 2019 - A Food and Drug Administration proposal to substitute detailed reviews of new drugs written by specific ...
Posted by Michael Wonder on 23 Aug 2018
Case-control studies: using “real world” evidence to assess association
23 August 2018 - Associations between patient characteristics or treatments received and clinical outcomes are often first described using observational data, ...
Posted by Michael Wonder on 06 Jan 2018
Association of immunotherapy with durable survival as defined by value frameworks for cancer care
28 December 2017 - Modern immuno-oncology agents have generated great excitement because of their potential to provide durable survival for some ...
Posted by Michael Wonder on 05 Jul 2017
Home-to-home time — measuring what matters to patients and payers
5 July 2017 - Length of hospital stay is no longer an accurate reflection of the patient’s experience of an episode ...
Posted by Michael Wonder on 05 Jul 2017
Patient reported outcomes — are they living up to their potential?
5 July 2017 - There is a growing chorus of support for measuring patient-reported outcomes in clinical care. ...
Posted by Michael Wonder on 21 Nov 2016
Amgen eyes spending caps to win payer nods on migraine prospect erenumab
21 November 2016 - Note to drugmakers negotiating with payers: it’s not the price tag that’s the problem, or at ...