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31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for ...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 01 Jun 2023
Inflation Reduction Act undermines cancer medicine development
1 June 2023 - The price setting provisions in the Inflation Reduction Act acutely impact the research and development (R&D) ...
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 06 Feb 2023
Actions to support the development of medicines for children
6 February 2023 - Regulators in the European Union have taken several initiatives in the past four years to increase the ...
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 29 Sep 2022
EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products
29 September 2022 - EMA is launching a pilot to support the translation of basic research developments into medicines that could ...
Posted by Michael Wonder on 04 Feb 2022
EU watchdog says supports fast development of Omicron only vaccine
3 February 2022 - The European Union's drug regulator said on Thursday it would support a filing for approval of ...
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 23 Sep 2021
Canada should negotiate a fairer share of drug R&D costs
23 September 2021 - Instead of relying on price regulation, Canada should engage in negotiations about drug pricing. ...
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 18 Apr 2021
Cancer researcher David Thomas says more should be done attract big pharma
18 April 2021 - A Garvan Institute cancer researcher says the government needs to attract big pharmaceutical companies to Australia ...
Posted by Michael Wonder on 28 Mar 2021
MHRA pilot seeks evidence of patient involvement in R&D
25 March 2021 - The UK MHRA has begun a pilot project to encourage patient involvement in drug development, asking ...
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. ...