Blog
RSS FeedPosted by Michael Wonder on 18 Jun 2025
FDA to issue new Commissioner’s national priority vouchers to companies supporting US national interests
17 June 2025 - The US FDA today announced its Commissioner’s National Priority Voucher program to enhance the health interests of ...
Posted by Michael Wonder on 14 Jun 2025
No drug price pledges by Pfizer, others in talks with US Government, Pfizer CEO says
9 June 2025 - Pfizer and other drug companies have met with the Trump administration to discuss lowering US drug ...
Posted by Michael Wonder on 12 Jun 2025
EMA 2024 annual report is published
10 June 2025 - The EMA’s annual report 2024 published today gives insights into the Agency’s strategic priorities and contributions ...
Posted by Michael Wonder on 11 Jun 2025
Priorities for a new FDA
10 June 2025 - Why does it take more than 10 years for a new drug to come to market? Why ...
Posted by Michael Wonder on 21 May 2025
FDA takes steps to enhance state importation programs to help lower prescription drug prices
21 May 2025 - The US FDA is continuing to take steps to help state importation programs provide safe, effective and ...
Posted by Michael Wonder on 12 May 2025
Trump says he will sign executive order on drug price caps
11 May 2025 - President Trump said Sunday he will sign an executive order Monday to cap prescription drug and ...
Posted by Michael Wonder on 07 Apr 2025
Rule of Two for faster access to medicines
3 April 2025 - Associate Health Minister David Seymour is welcoming Cabinet’s decision to enable medicines to be approved in ...
Posted by Michael Wonder on 03 Apr 2025
Platform clinical trials for the efficient evaluation of multiple treatments
31 March 2025 - For some medical conditions, including conditions without effective treatments, multiple promising but unproven therapies may exist, with ...
Posted by Michael Wonder on 30 Mar 2025
Bristol Myers Squibb receives positive CHMP opinion for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for resectable non-small cell lung cancer in patients with tumour cell PD-L1 expression ≥1%
28 March 2025 - Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant ...
Posted by Michael Wonder on 27 Mar 2025
American pharmaceutical boss does not support tariffs on Australian medicines
26 March 2025 - The head of one of America's largest pharmaceutical companies says he does not support tariffs on ...
Posted by Michael Wonder on 21 Mar 2025
Why US drug giants are so angry about Australia’s PBS
20 March 2025 - US pharmaceutical giants hope the protectionist Trump administration will force Australia to increase the price it pays ...
Posted by Michael Wonder on 20 Mar 2025
Australia defends PBS as US companies urge Trump to impose reciprocal tariffs
19 March 2025 - American medical giants have labelled the federal government's PBS "egregious and discriminatory" and have pressed US ...
Posted by Michael Wonder on 20 Mar 2025
Big pharma’s plea to Trump to punish Australia for cheaper medicines
19 March 2025 - American medical giants have slammed the $18 billion pharmaceutical benefits scheme in a plea to US ...
Posted by Michael Wonder on 08 Mar 2025
FDA’s accelerated approval guidance gets pushback from industry
7 March 2025 - The pharmaceutical industry has some questions regarding the US FDA's recent guidance on its accelerated approval ...
Posted by Michael Wonder on 03 Mar 2025
Supporting the development of drugs for rare diseases - the importance of regulatory transparency
1 March 2025 - Transparency regarding the information submitted to the FDA and the agency’s decision making could have far-reaching ...