Blog
RSS FeedPosted by Michael Wonder on 05 Aug 2019
FDA issues draft guidance regarding clinical trial design for newborns
31 July 2019 - Today, the U.S. Food and Drug Administration issued the draft guidance, General Clinical Pharmacology Considerations for Neonatal ...
Posted by Michael Wonder on 04 Aug 2019
Vas Narasimhan of Novartis: ‘we are not at all prepared for a pandemic’
1 August 2019 - The son of Indian immigrants read Greek philosophy and worked at McKinsey before joining a giant drug ...
Posted 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 11 Jul 2019
New drugs: where did we go wrong and what can we do better?
10 July 2019 - More than half of new drugs entering the German health care system have not been shown to ...
Posted by Michael Wonder on 09 Jul 2019
GSK welcomes the UK trial of subscription-style payment system for pharma companies to incentivise creation of new antibiotics
9 July 2019 - GSK is committed to tackling antimicrobial resistance as part of a sustained, multi-stakeholder response to this global ...
Posted by Michael Wonder on 09 Jul 2019
UK launches subscription style payment pilot to incentivise pharma antibiotics R&D
9 July 2019 - The UK is to try out a subscription-style payment model aimed at incentivising pharma and biotech ...
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27 June 2019 - The draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, when finalised, will describe the agency’s ...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. ...