Blog
RSS FeedPosted by Michael Wonder on 08 Dec 2016
Interpreting geographic variations in results of randomised, controlled trials
7 December 2016 - Clinical triallists generally accept the premise that surprising results in subgroups of a randomised, controlled trial most ...
Posted by Michael Wonder on 08 Dec 2016
1 patient, 7 tumours and 100 billion cells equal 1 striking recovery
7 December 2016 - The remarkable recovery of a woman with advanced colon cancer, after treatment with cells from her ...
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 28 Nov 2016
Republicans reach deal to pass Cures Act by end of year, but Democrats pushing for changes
27 November 2016 - House and Senate leaders announced late Friday night that they had finally hammered out a deal ...
Posted by Michael Wonder on 17 Nov 2016
FDA research to help speed development of Zika virus vaccines and therapeutics
17 November 2016 - Neonatal mouse model provides a new platform for Zika virus research. ...
Posted by Michael Wonder on 22 Oct 2016
Kite Pharma's CEO on bringing cancer-killing T-cells to the FDA
20 October 2016 - During a Q&A session with Wall Street analysts, CEO Arie Belldegrun was thrilled when an audience member ...
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
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 ...
Posted by Michael Wonder on 17 Oct 2016
FDA awards 21 grants to stimulate product development for rare diseases
17 October 2016 - The U.S. FDA today announced that it has awarded 21 new clinical trial research grants totaling ...
Posted by Michael Wonder on 13 Oct 2016
Novel drugs for depression
13 October 2016 - A new generation of drugs could change the way depression is treated. ...
Posted by Michael Wonder on 09 Oct 2016
Teva and Celltrion announce exclusive biosimilar commercial partnership
6 October 2016 - Teva Pharmaceutical Industries Ltd and Celltrion Healthcare have announced that the companies have entered into an exclusive ...
Posted by Michael Wonder on 03 Oct 2016
Obama extends controversial program for rare pediatric drugs
30 September 2016 - Despite objections from his own regulators, President Barack Obama signed into law a bill on Friday ...
Posted by Michael Wonder on 29 Sep 2016
FDA eyes new diabetes outcome measures
29 September 2016 - A recent FDA workshop brought new diabetes outcome measures to the table, focusing on patient-oriented outcome measures. ...
Posted by Michael Wonder on 27 Sep 2016
Axovant Sciences receives FDA fast track designation for intepirdine as an investigational treatment for dementia with Lewy bodies
26 September 2016 - Axovant Sciences today announced that the company has received fast track designation for its investigational new drug ...