Blog
RSS FeedPosted by Michael Wonder on 31 Jul 2019
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)
31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...
Posted by Michael Wonder on 29 Jul 2019
Harms from uninformative clinical trials
25 July 2019 - Individuals who enroll in clinical trials do so with the belief that their participation will help ...
Posted by Michael Wonder on 17 Jul 2019
Trump to order drive for improved flu vaccine
16 July 2019 - President Donald Trump is readying an executive order that would direct HHS to overhaul the development ...
Posted by Michael Wonder on 27 Jun 2019
FDA takes new step to help advance the transition of certain biological products
27 June 2019 - Today the U.S. FDA issued a proposed rule to amend its regulations on the use of master ...
Posted by Michael Wonder on 27 Jun 2019
FDA takes steps to spark development of heart failure drugs
27 June 2019 - The draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, when finalised, will describe the agency’s ...
Posted by Michael Wonder on 24 Jun 2019
Incorporating patient preferences in non-inferiority trials
24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...
Posted by Michael Wonder on 20 Jun 2019
Sustainable discovery and development of antibiotics — is a non-profit approach the future?
19 June 2019 - Shifting to a nonprofit-driven model for development of antibiotics could encourage discovery and development of truly needed ...
Posted by Michael Wonder on 14 Jun 2019
Pharma blockchains AI for drug development
15 June 2019 - The venture would allow AI to be trained on millions of datapoints across databases from several drug ...
Posted by Michael Wonder on 06 Jun 2019
Pfizer denies report it hid possible Alzheimer’s breakthrough
5 June 2019 - Pfizer is fighting back against a report that it hid the potential of a blockbuster drug ...
Posted by Michael Wonder on 05 Jun 2019
Pharma groups combine to promote drug discovery with AI
5 June 2019 - Blockchain system allows companies to share data without revealing commercial secrets. ...
Posted by Michael Wonder on 05 Jun 2019
Pfizer knew drug may prevent Alzheimer's. Why didn't it tell us?
5 June 2019 - A team of researchers inside Pfizer made a startling find in 2015: the company's blockbuster rheumatoid ...
Posted by Michael Wonder on 02 May 2019
The antibiotic industry is broken
2 May 2019 - Take inspiration from the entertainment industry. ...
Posted by Michael Wonder on 02 May 2019
FDA's efforts to advance the development of gene therapy
1 May 2019 - Gene therapy has been on the horizon for several decades and has now become a reality in ...
Posted by Michael Wonder on 20 Apr 2019
FDA's efforts to advance the development of biologics
17 April 2019 - The FDA’s Center for Biologics Evaluation and Research is working at the forefront of 21st century ...
Posted by Michael Wonder on 10 Apr 2019
FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials
10 April 2019 - Can real-world evidence substitute for a clinical drug trial that meets the full gold standard on data? ...