Blog
RSS FeedPosted by Michael Wonder on 28 Apr 2020
International regulators pledge collective support to combat COVID-19 pandemic
28 April 2020 - EMA has endorsed a joint COVID-19 statement published today by the International Coalition of Medicines Regulatory ...
Posted by Michael Wonder on 18 Apr 2020
NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options
17 April 2020 - The National Institutes of Health (NIH) and the Foundation for the NIH are bringing together more than ...
Posted by Michael Wonder on 15 Apr 2020
Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19
14 April 2020 - Candidate vaccine expected to enter clinical trials in the second half of 2020 and, if successful, to ...
Posted by Michael Wonder on 07 Apr 2020
Global plasma leaders collaborate to accelerate development of potential COVID-19 hyperimmune therapy
6 April 2020 - Partnership brings together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the ...
Posted by Michael Wonder on 03 Apr 2020
International regulators discuss available knowledge supporting COVID-19 medicine development
3 April 2020 - On 2 April, regulators from around the world joined the second workshop on COVID-19 organised by ...
Posted by Michael Wonder on 02 Apr 2020
COVID-19 has changed how the world does science, together
1 April 2020 - Never before, scientists say, have so many of the world’s researchers focused so urgently on a single ...
Posted by Michael Wonder on 26 Mar 2020
Crowdsourcing to fight COVID-19
26 March 2020 - “We are trying to fly the plane while we are building it.” ...
Posted by Michael Wonder on 26 Mar 2020
FDA continues to support transparency and collaboration in drug approval process as the clinical data summary pilot concludes
26 March 2020 - As our society becomes more global, it has become increasingly clear that the U.S. FDA needs to ...
Posted by Michael Wonder on 26 Mar 2020
Novartis and life sciences companies commit expertise and assets to the fight against COVID-19 pandemic alongside Bill & Melinda Gates Foundation
26 March 2020 - Collaboration to address product development and scale up challenges posed by current pandemic. ...
Posted 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 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 04 Mar 2020
International work-sharing initiative - baloxavir marboxil (Xofluza)
5 March 2020 - The Therapeutic Goods Administration (TGA) has approved a new medicine for the treatment of influenza (flu) as ...
Posted by Michael Wonder on 02 Dec 2019
Engaging patients in medicines regulation: a tale of two agencies
2 December 2019 - The EMA and the US FDA have committed to engaging patients in their regulatory processes to promote ...
Posted by Michael Wonder on 26 Nov 2019
Teva, drug makers in talks with U.S. to end generics probes
26 November 2019 - Deferred prosecution agreements among resolutions discussed. ...
Posted by Michael Wonder on 25 Nov 2019
Acalabrutinib receives TGA approval for CLL and SLL cancers
25 November 2019 - The Therapeutic Goods Administration has approved the use of acalabrutinib (Calquence) for the treatment of patients ...