Blog
RSS FeedPosted by Michael Wonder on 13 Jul 2020
TGA publishes more details on its approval of COVID-19 medicine Veklury
13 July 2020 - Remdesivir granted conditional approval in record time. ...
Posted by Michael Wonder on 08 Jul 2020
ICER reschedules cystic fibrosis public meeting for 27 August 2020
8 July 2020 - Registration is now open. ...
Posted by Michael Wonder on 06 Jul 2020
Developing a SARS-CoV-2 vaccine at warp speed
6 July 2020 - The coronavirus disease 2019 (COVID-19) pandemic has unleashed major and substantial changes in the provision of health ...
Posted by Michael Wonder on 05 Jul 2020
FDA Commissioner says he can't predict when vaccine will be ready after Trump's timeline claims
5 July 2020 - Food and Drug Administration Commissioner Stephen Hahn said Sunday that he would not make a prediction ...
Posted by Michael Wonder on 17 Jun 2020
Delay in decision on modifying funded access to mifepristone and misoprostol proposal
17 June 2020 - PHARMAC would like to advise all interested parties that there will be a delay in the decision ...
Posted by Michael Wonder on 17 Jun 2020
New Zealand's slow medicine uptake leads to 800 diabetes deaths each year
17 June 2020 - The Diabetes Foundation Aotearoa has estimated in a submission to PHARMAC last month that New Zealand’s ...
Posted by Michael Wonder on 15 Jun 2020
Biogen’s FDA application for Alzheimer’s drug drags on
15 June 2020 - Biogen’s filing of aducanumab, an investigational Alzheimer’s drug, for U.S. approval is drifting from its initial ...
Posted by Michael Wonder on 14 Jun 2020
Analysis of PBAC submissions and outcomes for medicines (2010–2018)
11 June 2020 - Sean Lybrand and I reviewed the Pharmaceutical Benefits Advisory Committee submissions and their related outcomes and timelines ...
Posted by Michael Wonder on 13 Jun 2020
Antimicrobials benefited from expedited FDA programs more than other drugs
12 June 2020 - Amid concerns over the need for more antimicrobials, a new analysis finds these medicines benefited more ...
Posted by Michael Wonder on 11 Jun 2020
U.S. FDA Commissioner says agency seeks fast review of COVID-19 products
11 June 2020 - The U.S. FDA is seeking to review treatments and tests for COVID-19 “as fast as we can” ...
Posted by Michael Wonder on 03 Jun 2020
The FDA should not rush a COVID-19 vaccine
2 June 2020 - Vaccines are widely expected to offer the best way out of the COVID-19 pandemic. ...
Posted by Michael Wonder on 03 Jun 2020
Antimicrobial approvals are not bottlenecked by FDA
3 June 2020 - Sponsors seeking US FDA approval for anti-microbial drugs accessed expedited clinical testing and review programs at least ...
Posted by Michael Wonder on 03 Jun 2020
Hahn: FDA will make some changes amid COVID-19 permanent
1 June 2020 - The US FDA will look to permanently implement some of the processes and policies adopted in ...
Posted by Michael Wonder on 02 Jun 2020
Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
2 June 2020 - Novartis today announced that it has received notice from the US FDA that the agency has extended ...
Posted by Michael Wonder on 02 Jun 2020
Estimating the cost of delayed generic drug entry to Medicaid
1 June 2020 - Delays in market entry of generic drugs are common. ...