Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 02 Mar 2025
mRESVIA RSV vaccine approved to protect patients aged 60 and over
28 February 2025 - A study found that around 4 months after vaccination, people who received the respiratory syncytial virus vaccine had ...
Posted by Michael Wonder on 26 Feb 2025
Value for private health insurance
26 February 2025 - The Australian Government has ensured Australians get value for money from their private health insurance. ...
Posted by Michael Wonder on 17 Feb 2025
Out of pocket getting out of hand - reducing the financial toxicity of rapidly approved drugs
15 February 2025 - In 2023, Teresa was diagnosed with amyotrophic lateral sclerosis. Several months later, her family started a GoFundMe ...
Posted by Michael Wonder on 15 Feb 2025
Efanesoctocog alfa approved to prevent and treat bleeding in children and adults with severe or moderate haemophilia A
14 February 2025 - The MHRA has today approved efanesoctocog alfa (Altuvoct) to be used to treat and prevent bleeding in ...
Posted by Michael Wonder on 07 Feb 2025
US FDA approves Emblaveo (aztreonam and avibactam) for the treatment of adults with complicated intra-abdominal infections with limited or no treatment options
7 February 2025 - Emblaveo is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the US FDA to ...
Posted by Michael Wonder on 05 Feb 2025
Izchiq vaccine approved to protect adults against Chikungunya
4 February 2025 - The MHRA has today approved the vaccine chikungunya vaccine (live) (Ixchiq) to protect adults against chikungunya disease, ...
Posted by Michael Wonder on 05 Feb 2025
Update on regulatory review of lecanemab for early Alzheimer’s disease in the European Union (July 2024)
26 July 2024 - Eisai and Biogen announced today that the CHMP of the EMA has adopted a negative opinion on ...
Posted by Michael Wonder on 04 Feb 2025
Comanche Biopharma awarded Innovation passport designation by the UK Innovative Licensing and Access Pathway Steering Group for CBP-4888, an investigational siRNA drug candidate for the treatment of sFlt1-mediated preterm pre-eclampsia
30 January 2025 - A novel investigational drug candidate, CBP-4888 leverages the precise targeting ability of siRNAs to downregulate sFlt1 ...
Posted by Michael Wonder on 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...
Posted by Michael Wonder on 01 Feb 2025
Refined interpretation of the Mutual Recognition Agreement between Canada and Switzerland
31 January 2025 - Swissmedic and Health Canada agreed to expand their approach regarding the implementation of the current mutual ...