Blog
RSS FeedPosted by Michael Wonder on 06 Apr 2017
Regulatory review of new therapeutic agents — FDA versus EMA (2011–2015)
6 April 2017 - The FDA faces continual pressure to accelerate the regulatory review and approval of new medicines. ...
Posted by Michael Wonder on 06 Apr 2017
FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions
6 April 2017 - The U.S. FDA today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk tests for ...
Posted by Michael Wonder on 05 Apr 2017
Differences in treatment effect size between overall survival and progression-free survival in immunotherapy trials: a meta-epidemiologic study of trials with results posted at ClinicalTrials.gov
4 April 2017 - Tan et al. compared treatment effect sizes between overall survival and progression-free survival in trials of ...
Posted by Michael Wonder on 05 Apr 2017
Gottlieb as FDA commissioner would be music to pharma’s ears
4 April 2017 - When President Trump nominated Scott Gottlieb for commissioner of the FDA, you could almost hear the ...
Posted by Michael Wonder on 05 Apr 2017
Vaccines and the Trump Administration
4 April 2017 - Writing recently in the New York Times, infectious disease physician Peter Hotez warned: “It’s looking as ...
Posted by Michael Wonder on 04 Apr 2017
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) in previously treated dMMR or MSI-H metastatic colorectal cancer
4 April 2017 - Application based on results from Phase 2 CheckMate-142 study. ...
Posted by Michael Wonder on 04 Apr 2017
AbbVie announces Ibrutinib (Imbruvica) supplemental new drug application for previously treated chronic graft-versus-host-disease accepted for review by U.S. FDA
4 April 2017 - AbbVie today announced a supplemental new drug application was accepted for review by the U.S. FDA for ...
Posted by Michael Wonder on 04 Apr 2017
Evaluation of evidence of statistical support and corroboration of sub-group claims in randomised clinical trials
3 April 2017 - Many published randomised clinical trials make claims for subgroup differences. ...
Posted by Michael Wonder on 04 Apr 2017
AB2 Bio’s tadekinig alfa therapy receives breakthrough therapy designation from the US FDA for the treatment of monogenic, interleukin-18 associated auto-inflammatory conditions with ongoing systemic inflammation
3 April 2017 - Breakthrough therapy designation recognises the major potential therapeutic benefits of tadekinig alfa in the treatment of ...
Posted by Michael Wonder on 04 Apr 2017
Teva Announces FDA approval of Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease
3 April 2017 - Approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a ...
Posted by Michael Wonder on 04 Apr 2017
Jazz Pharmaceuticals completes rolling submission of new drug application for Vyxeos (CPX-351), an investigational treatment for acute myeloid leukaemia
3 April 2017 - Jazz Pharmaceuticals today announced the completion on 31 March 2017 of a rolling submission of a new ...
Posted by Michael Wonder on 02 Apr 2017
The nominee to run America’s drug regulator is a sound choice
1 April 2017 - Scott Gottlieb is close to the pharma industry but knows its tactics. ...
Posted by Michael Wonder on 02 Apr 2017
Ibrance (palbociclib) receives FDA regular approval and expanded indication for first-line HR+, HER2- metastatic breast cancer
31 March 2017 - Pfizer today announced that the U.S. FDA has approved a supplemental new drug application for its first-in-class ...
Posted by Michael Wonder on 02 Apr 2017
Kite completes submission of U.S. biologics license application for axicabtagene ciloleucel as the first CAR-T therapy for the treatment of patients with aggressive non-Hodgkin lymphoma
31 March 2017 - Kite is preparing for potential approval and launch for axicabtagene ciloleucel in 2017. ...
Posted by Michael Wonder on 01 Apr 2017
Aura Biosciences announces initiation of Phase 1b clinical trial and receipt of FDA fast track designation for AU-011 for the treatment of primary ocular melanoma
30 March 2017 - First patient dosed with light-activated AU-011 at Wills Eye Hospital in Philadelphia. ...