Blog
RSS FeedPosted 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26 April 2021 - Recent draft guidance from the US FDA addresses the non-clinical safety data to support investigational new ...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. ...
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 09 Sep 2020
COVID-19 vaccine development
9 September 2020 - Australia’s COVID-19 Vaccine and Treatment Strategy supports early access to, and delivery of, safe and effective COVID-19 ...