Blog
RSS FeedPosted by Michael Wonder on 17 Aug 2016
The FDA, Juno Therapeutics, and the ethical imperative of transparency
15 August 2016 - Despite deaths, investigational new drugs are still protected trade secrets of the manufacturer. ...
Posted by Michael Wonder on 16 Aug 2016
Addressing challenges of innovative cancer immunotherapy medicines
16 August 2016 - EMA workshop to discuss treatments based on genetically modified T-cells. ...
Posted by Michael Wonder on 11 Aug 2016
The future of cardiovascular medicine from the regulatory perspective
10 August 2016 - For many years, the American public and the entire world have benefited from the U.S. FDAs’ regulatory ...
Posted by Michael Wonder on 09 Aug 2016
Adaptive pathways: EMA still leaves open questions unanswered
9 August 2016 - Current EMA report on the pilot project again documents perplexity regarding the use of “real world data”. ...
Posted by Michael Wonder on 04 Aug 2016
Drugmakers split on whether to include interchangeability statement in biosimilar labels
3 August 2016 - Drug, biologic and biosimilar companies’ comments on US FDA draft guidance on biosimilar labeling reveals a major ...
Posted by Michael Wonder on 04 Aug 2016
Adaptive pathways: key learnings and next steps
3 August 2016 - EMA publishes report on pilot project and will organise workshop in December to further explore concept ...
Posted by Michael Wonder on 03 Aug 2016
New layout for EMA scientific guidelines
2 August 2016 - Improved presentation to help website users. ...
Posted by Michael Wonder on 03 Aug 2016
New biomedical fund to capitalise on our research and entrepreneurial strengths
3 August 2016 - A new fund to accelerate the development and commercialisation of Australian biomedical discoveries is now officially launched. ...
Posted by Michael Wonder on 02 Aug 2016
Call for NHS to haggle with drug companies over price of new treatments
1 August 2016 - Opposition politicians are calling for the Scottish NHS to haggle with drug companies over the price of ...
Posted by Michael Wonder on 01 Aug 2016
Development of medicines to treat tuberculosis
1 August 2016 - Comments on draft guidance invited until 31 January 2017. ...
Posted by Michael Wonder on 31 Jul 2016
Modelling and simulation in the development and regulatory review of medicines
29 July 2016 - Comments on new guidance invited until 31 January 2017. ...
Posted by Michael Wonder on 28 Jul 2016
Betting on hepatitis C: how financial speculation in drug development influences access to medicines
27 July 2016 - Victor Roy and Lawrence King argue that the acquisition strategies of drug companies magnify development costs and ...
Posted by Michael Wonder on 08 Jul 2016
The bottom line
8 July 2016 - t's hard to put a value on a human life. When you're well, perhaps you don't think ...
Posted by Michael Wonder on 05 Jul 2016
FDA should stand firm on stem-cell treatments
5 July 2016 - You may have heard that regulators in the United States are too strict when it comes to ...
Posted by Michael Wonder on 05 Jul 2016
Top officials aim to reshape the FDA to prepare for 'avalanche' of cancer products
30 June 2016 - For 20 years, Richard Pazdur has run the office of the FDA charged with evaluating new cancer ...