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RSS FeedPosted by Michael Wonder on 24 Jun 2020
Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24 June 2020 - Under the umbrella of the International Coalition of Medicines Regulatory Authorities, international regulators discussed COVID-19 vaccine ...
Posted by Michael Wonder on 18 Jun 2020
Clinical trial costs to develop a new drug may actually be rather modest — or so one study suggests
18 June 2020 - For years, the pharmaceutical industry has maintained that the costs to develop medicines accounts for rising ...
Posted by Michael Wonder on 16 Jun 2020
First drug proves able to improve survival from COVID-19, trial shows
17 June 2020 - A low-cost, widely used anti-inflammatory drug has improved survival in patients with COVID-19, scientists say, the ...
Posted by Michael Wonder on 04 Jun 2020
The Lancet, New England Journal retract COVID-19 studies, including one that raised safety concerns about malaria drugs
4 June 2020 - The Lancet, one of the world’s top medical journals, on Thursday retracted an influential study that ...
Posted by Michael Wonder on 03 Jun 2020
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...
Posted by Michael Wonder on 28 May 2020
COVID-19: researchers halt patient recruitment for hydroxychloroquine trial
28 May 2020 - Australian researchers have suspended patient recruitment in a major clinical trial of the controversial anti-malaria drug ...
Posted by Michael Wonder on 26 May 2020
EMA calls for high-quality observational research in context of COVID-19
26 May 2020 - For observational studies of real world data in COVID-19, EMA calls for transparency for protocols and results, ...
Posted by Michael Wonder on 26 May 2020
Australians stick with malaria drug hydroxychoroquine trial
26 May 2020 - Australian researchers are pressing ahead with administering the controversial antimalarial drug hydroxychloroquine in at least one ...
Posted by Michael Wonder on 25 May 2020
WHO pauses trial of hydroxychloroquine in COVID-19 patients due to safety concerns
26 May 2020 - The World Health Organisation has suspended testing the malaria drug hydroxychloroquine in COVID-19 patients due to ...
Posted by Michael Wonder on 15 May 2020
International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
15 May 2020 - Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of ...
Posted by Michael Wonder on 05 May 2020
Pfizer and Biontech dose first participants in the U.S. as part of global COVID-19 MRNA vaccine development program
5 May 2020 - Pfizer and BioNTech ramping up manufacturing capabilities to further increase production capacity in 2020/2021. ...
Posted by Michael Wonder on 05 May 2020
Bill Gates donates $10 million to Australian trial of immune-boosting vaccine
5 May 2020 - Bill Gates has donated $10 million to an Australian trial of a vaccine that researchers hope ...
Posted by Michael Wonder on 04 May 2020
Randomised clinical trials and COVID-19: managing expectations
4 May 2020 - Despite the millions of cases and hundreds of thousands of deaths that have occurred in this devastating ...
Posted by Michael Wonder on 24 Apr 2020
Mesoblast claims coronavirus treatment breakthrough
24 April 2020 - Stem cell-focused biotech Mesoblast has claimed a breakthrough in its experimental therapy to treat patients with ...
Posted by Michael Wonder on 23 Apr 2020
Increasing access to FDA inspection reports on irregularities and misconduct in clinical trials
23 April 2020 - Transparency related to clinical trial protocols and data has become the expected standard over the past 2 ...