Blog
RSS FeedPosted 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 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 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 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 16 Nov 2016
How can clinical research networks support developers of medicines for children?
16 November 2016 - Event to be broadcast live on 1 December 2016. ...
Posted by Michael Wonder on 15 Nov 2016
The European Commission launches a public consultation on the Paediatric Regulation
15 November 2016 - This marks ten years since the legislation entered into force. ...
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
Modelling and simulation in the development of medicines
14 November 2016 - Watch live broadcast of expert discussion at EMA. ...
Posted by Michael Wonder on 14 Nov 2016
How to facilitate development of cancer treatment based on genetically modified T-cells
8 November 2016 - Watch live broadcast of expert discussion at EMA. ...
Posted by Michael Wonder on 13 Nov 2016
How big data can be used for the development and regulation of medicines
8 November 2016 - EMA workshop broadcast live on 14-15 November. ...
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 ...