Blog
RSS FeedPosted by Michael Wonder on 11 Dec 2020
CSL, University of Queensland coronavirus vaccine trials halted
11 December 2020 - CSL and University of Queensland researchers knew of the potential for false HIV positives in the ...
Posted by Michael Wonder on 10 Dec 2020
Australian COVID vaccine terminated due to HIV ‘false positives’
11 December 2020 - A billion-dollar deal for the Morrison government to buy more than 50 million doses of the ...
Posted by Michael Wonder on 26 Nov 2020
After admitting mistake, AstraZeneca faces difficult questions about its vaccine
25 November 2020 - Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures ...
Posted by Michael Wonder on 25 Nov 2020
Medical trial delays see Australians wait for rare disease treatment
25 November 2020 - Patients with rare diseases are entering ‘random lottery’ draws for clinical trials because Australia is too slow ...
Posted by Michael Wonder on 11 Nov 2020
FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development
9 November 2020 - To further promote and protect public health, it is important that people who are in clinical trials ...
Posted by Michael Wonder on 06 Nov 2020
Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme
6 November 2020 - The TGA has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical ...
Posted by Michael Wonder on 23 Oct 2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...
Posted by Michael Wonder on 12 Oct 2020
Efficacy trials cost more, take longer for biosimilars than originators
11 October 2020 - Average clinical efficacy testing cost millions of dollars more for Phase 3 biosimilar studies than for ...
Posted by Michael Wonder on 08 Oct 2020
CSL confirms UQ vaccine production, trials set for December
8 October 2020 - CSL says it is talking with partner organisations to help roll out doses of the University ...
Posted by Michael Wonder on 24 Aug 2020
FDA may fine clinical trial sponsors that don’t report data
24 August 2020 - The US FDA has said it will penalise sponsors of clinical trials that do not report ...
Posted by Michael Wonder on 18 Aug 2020
FDA finalises penalties for clinical trial sponsors that don’t share data, but critics say they fall short
18 August 2020 - After a year of deliberation, the FDA released final guidelines for penalising clinical trial sponsors that ...
Posted by Michael Wonder on 17 Aug 2020
Clinical trials of coronavirus drugs are taking longer than expected
14 August 2020 - Antibody trials sponsored by Regeneron and Eli Lilly are off to a slow start because of a ...
Posted by Michael Wonder on 16 Aug 2020
Direct or indirect comparison: reliance on innovative drug data key to engaging data protection
15 August 2020 - The Federal Court recently issued its decision in Natco v Canada (Minister of Health), 2020 FC 788, ...
Posted by Michael Wonder on 03 Aug 2020
Characteristics and strength of evidence of COVID-19 studies registered on ClinicalTrials.gov
27 July 2020 - The coronavirus disease 2019 (COVID-19) pandemic has led to a massive activation of clinical research. ...
Posted by Michael Wonder on 31 Jul 2020
Weighing the benefits and risks of proliferating observational treatment assessments: observational cacophony, randomised harmony
31 July 2020 - Amid the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, substantial effort is being directed toward ...