Blog
RSS FeedPosted by Michael Wonder on 02 Jun 2023
FDA considers new efficacy endpoint for diabetes drugs
31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for ...
Posted by Michael Wonder on 15 Feb 2023
Transferable exclusivity voucher: a flawed incentive to stimulate antibiotic innovation
9 February 2023 - As antibiotic resistance increases globally, antibiotic innovation is struggling. The WHO states that the antibiotic clinical pipeline ...
Posted by Michael Wonder on 11 Feb 2023
State of the Union highlights America’s awkward conversation on financing the development of new medicines
9 February 2023 - Science, medicine, health care, and paying for medicines featured prominently in President Joe Biden’s State of ...
Posted by Michael Wonder on 05 Nov 2022
FDA finalises umbrella trial guidance for cell and gene therapies
4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or ...
Posted by Michael Wonder on 23 Nov 2021
The BBB’s threat to biosimilar drug development
23 November 2021 - In 2019, longtime pharmaceutical industry critic, Peter Bach, took to the Wall Street Journal to declare that ...
Posted by Michael Wonder on 17 Oct 2021
How much does it cost to research and develop a new drug? A systematic review and assessment
15 October 2021 - Debate over the viability of the current commercial research and development model is on-going. ...
Posted by Michael Wonder on 27 Apr 2021
FDA guidance says sponsors should provide 'convincing' proof of concept data to support INDs for individualised medicine
26 April 2021 - Recent draft guidance from the US FDA addresses the non-clinical safety data to support investigational new ...
Posted by Michael Wonder on 25 Mar 2021
Bright side of the moonshots
25 March 2021 - COVID-19 has brought together biomedical technologies that will transform human health. ...
Posted by Michael Wonder on 25 Mar 2021
Taxpayers fund research and drug companies make a fortune
24 March 2021 - The pharmaceutical industry doesn’t want things to change, but Americans can have both lower prices and innovation. ...
Posted by Michael Wonder on 15 Jan 2021
Funding of pharmaceutical innovation during and after the COVID-19 pandemic
14 January 2021 - The COVID-19 pandemic has highlighted the available mechanisms for funding research, development, manufacturing, and distribution in the ...
Posted by Michael Wonder on 02 Oct 2020
Development of COVID-19 vaccine won’t be affected by politics, Pfizer CEO says
1 October 2020 - Albert Bourla sent an all-hands letter saying company won’t bow to political pressure. ...
Posted by Michael Wonder on 10 Sep 2020
Some good news on COVID-19
9 September 2020 - The virus seems to generate a robust and fairly long-lasting immune response. ...
Posted by Michael Wonder on 27 Aug 2020
This is a heart drug that the world doesn’t need
27 August 2020 - Twenty years ago, perhaps the hottest area of drug research was on a class of compounds called ...
Posted by Michael Wonder on 06 Apr 2020
Bill Gates to spend billions on coronavirus vaccine development
5 April 2020 - Foundation to help build factories for the seven makers of the most-promising efforts. ...
Posted by Michael Wonder on 26 Oct 2019
Public sector financial support for late stage discovery of new drugs in the United States: cohort study
23 October 2019 - This study determined the extent to which late stage development of new drugs relies on support from ...