Blog
RSS FeedPosted by Michael Wonder on 19 Mar 2019
FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in paediatric patients, as part of efforts to end HIV infection
19 March 2019 - The U.S. FDA today issued two final guidances for industry to help product sponsors understand the ...
Posted by Michael Wonder on 14 Mar 2019
Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development
14 March 2019 - Modernizing clinical trials is an agency wide priority. ...
Posted by Michael Wonder on 05 Mar 2019
FDA is working to bridge gaps and meet needs for rare disease product development
28 February 2019 - There are approximately 7,000 rare diseases affecting an estimated 30 million people in the United States. ...
Posted by Michael Wonder on 05 Mar 2019
Moving upstream in anti-cancer drug development
4 March 2019 - The development of oncology drugs traditionally begins by studying them in heavily pretreated patients, and then working ...
Posted by Michael Wonder on 04 Mar 2019
Drug companies and doctors battle over the future of faecal transplants
3 March 2019 - As pharmaceutical companies seek to profit from the curative wonders of human faeces, doctors worry about new ...
Posted by Michael Wonder on 02 Mar 2019
Health Canada and CADTH launch new initiative to provide early parallel scientific advice
1 March 2019 - CADTH is pleased to announce a new collaboration with Health Canada and the Institut national d'excellence en ...
Posted by Michael Wonder on 02 Mar 2019
Treatment effects in multi-centre randomised clinical trials
1 March 2019 - It is common for treatments to be evaluated in clinical trials that involve many sites or centres, ...
Posted by Michael Wonder on 28 Feb 2019
“Repurposing” off-patent drugs offers big hopes of new treatments
28 February 2019 - Towards the end of 2014 a 66-year-old British man named Alistair had a seizure. A scan ...
Posted by Michael Wonder on 25 Feb 2019
Under representation of elderly in clinical trials: an analysis of the initial approval documents in the FDA database
25 February 2019 - A cross‐sectional, structured review of publicly available initial approval documents of FDA approved drugs was performed. ...
Posted by Michael Wonder on 23 Feb 2019
Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model in a pharmaceutical company
21 February 2019 - Evidence requirements and assessment methods access differ between health technology assessment agencies. ...
Posted by Michael Wonder on 29 Jan 2019
NICE Scientific Advice launches collaborative programme with life sciences industry body
29 January 2019 - NICE has announced a collaboration with the body which represents life sciences organisations in the UK. ...
Posted by Michael Wonder on 24 Jan 2019
Toward an effective innovation agenda
23 January 2019 - Digital technologies have transformed the U.S. and global economies, offering tremendous benefits to consumers and financial success ...
Posted by Michael Wonder on 23 Jan 2019
Modernising clinical trials for patients with cancer
23 January 2019 - Clinical trials involve evaluating and validating new therapies in humans and represent the fundamental means of making ...
Posted by Michael Wonder on 23 Jan 2019
Random-effects meta-analysis: summarising evidence with caveats
22 January 2019 - Questions involving medical therapies are often studied more than once. For example, numerous clinical trials have been ...
Posted by Michael Wonder on 17 Jan 2019
FDA updates guidance on development of rare disease therapies
17 January 2019 - The FDA has revised its draft guidance for developing rare disease treatments to include the use ...