Blog
RSS FeedPosted by Michael Wonder on 23 Mar 2020
FDA and EMA collaborate to facilitate SARS-CoV-2 vaccine development
23 March 2020 - Vaccines offer a way to build immunity to a disease-causing microorganism before one has ever been exposed ...
Posted by Michael Wonder on 23 Mar 2020
Fast-tracking research into treatments for COVID-19
21 March 2020 - The Australian Government will provide $13 million to fast-track research into treatments for the novel coronavirus (COVID-19). ...
Posted by Michael Wonder on 21 Mar 2020
Generating comparative evidence on new drugs and devices after approval
21 March 2020 - Certain limitations of evidence available on drugs and devices at the time of market approval often persist ...
Posted by Michael Wonder on 20 Mar 2020
Generating comparative evidence on new drugs and devices before approval
21 March 2020 - Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment ...
Posted by Michael Wonder on 20 Mar 2020
Coronavirus vindicates capitalism
19 March 2020 - Drug companies will save lives, even as Bernie Sanders is denouncing them. ...
Posted by Michael Wonder on 19 Mar 2020
FDA to fast track clinical trials for coronavirus therapies
19 March 2020 - FDA Commissioner Stephen Hahn said the agency will test chloroquine, an anti-malarial drug, as a coronavirus treatment. ...
Posted by Michael Wonder on 19 Mar 2020
Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments
19 March 2020 - EMA’s Human Medicines Committee has published a statement urging the EU research community to prioritise large randomised ...
Posted by Michael Wonder on 19 Mar 2020
Coronavirus (COVID-19) update: FDA continues to facilitate development of treatments
19 March 2020 - The U.S. FDA continues to play a critical role in the multifaceted all-of-government response to the ...
Posted by Michael Wonder on 18 Mar 2020
Hundreds of scientists scramble to find a Coronavirus treatment
17 March 2020 - In an ambitious international collaboration, researchers have “mapped” proteins in the coronavirus and identified 50 drugs to ...
Posted by Michael Wonder on 18 Mar 2020
First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development
18 March 2020 - Today, the first global regulatory workshop on COVID-19, was convened under the umbrella of the International Coalition ...
Posted by Michael Wonder on 18 Mar 2020
Medicines Australia welcomes Government’s COVID-19 package
18 March 2020 - Medicines Australia welcomes the $2.4 billion COVID-19 health package announced by the Prime Minister Scott Morrison ...
Posted by Michael Wonder on 17 Mar 2020
Making a new vaccine is not a race, it is a lottery
17 March 2020 - The COVID-19 novel coronavirus outbreak has challenged global researchers to find a vaccine. ...
Posted by Michael Wonder on 15 Mar 2020
FDA finalises guidance for industry on applications for drugs with inadequate generic competition
13 March 2020 - Today, the U.S. FDA finalised guidance for industry, “Competitive Generic Therapies” (CGTs), which describes the process that ...
Posted by Michael Wonder on 14 Mar 2020
COVID-19: developers of medicines or vaccines to benefit from free scientific advice
13 March 2020 - EMA provides full fee waivers for scientific advice applications from developers of potential therapeutics (to treat ...
Posted by Michael Wonder on 09 Mar 2020
FDA proposes broad approach for conducting safety trials for type 2 diabetes medications
9 March 2020 - The U.S. FDA today issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety ...