Blog
RSS FeedPosted by Michael Wonder on 30 Nov 2016
South Australia to commence PrEP trials
30 November 2016 - The South Australian Premier Jay Wetherill has announced people at high risk of contracting HIV will ...
Posted by Michael Wonder on 29 Nov 2016
Development challenges for medicines for central nervous system disorders
29 November 2016 - EMA conducts analysis of applications submitted between 1995 and 2014. ...
Posted by Michael Wonder on 29 Nov 2016
Quality of life, overall survival, and costs of cancer drugs approved based on surrogate endpoints
29 November 2016 - The lack of evidence of a clinically meaningful benefit for many cancer drugs approved by the US ...
Posted by Michael Wonder on 29 Nov 2016
Cancer immunology community seeks better end points
29 November 2016 - Drug developers are still hunting for surrogate end points that can better capture the benefits of checkpoint ...
Posted by Michael Wonder on 24 Nov 2016
Proposed cap on the R&D tax incentive will hamper clinical trials
22 November 2016 - The proposed $2 million cap on the R&D tax incentive will seriously damage clinical trials activity ...
Posted by Michael Wonder on 24 Nov 2016
Eli Lilly’s experimental Alzheimer’s drug fails in large trial
23 November 2016 - An experimental Alzheimer’s drug that had previously appeared to show promise in slowing the deterioration of ...
Posted by Michael Wonder on 19 Nov 2016
Workshop: towards new treatments for tuberculosis
18 November 2016 - The event will be broadcast on 25 November 2016. ...
Posted by Michael Wonder on 15 Nov 2016
Revising the guideline on first-in-human clinical trials
15 November 2016 - Changes are open for comments until end of February 2017. ...
Posted by Michael Wonder on 14 Nov 2016
Clinical trials for authorized biosimilars in the European Union: a systematic review
9 November 2016 - In 2006, Omnitrope (by Sandoz) was the first approved biosimilar in Europe. To date, 21 biosimilars for ...
Posted by Michael Wonder on 13 Nov 2016
A precision medicine approach to clinical trials
14 November 2016 - Five or 6 years ago, only 5% to 10% of patients at David Hong's clinic arrived with ...
Posted by Michael Wonder on 02 Nov 2016
Confounding by indication in clinical research
1 November 2016 - In the assessment of the effect of a treatment or potential risk factor—termed an exposure—on a patient ...
Posted by Michael Wonder on 22 Oct 2016
A biotech's depression drug returns from dead, setting up test for FDA
20 October 2016 - In January, Alkermes, a Waltham, Mass.-based biotechnology firm, announced that its experimental antidepressant, code-named ALKS 5461, ...
Posted by Michael Wonder on 21 Oct 2016
FDA official warns other drug makers not to copy Sarepta
20 October 2016 - Any company that plans to mimic the approach taken by Sarepta Therapeutics to win regulatory approval ...
Posted by Michael Wonder on 20 Oct 2016
Members unite in response to R&D tax incentive review
20 October 2016 - More than 100 members have attended AusBiotech consultation meetings this week or made submissions, as the ...
Posted by Michael Wonder on 20 Oct 2016
Celgene skips the placebo, fails drug development 101
19 October 2016 - Celgene is not some dinky micro-cap biotech lacking the resources or knowledge to conduct a rigorous clinical ...