Blog
RSS FeedPosted 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 19 Jun 2024
How AI is revolutionising drug development
17 June 2024 - In high-tech labs, workers are generating data to train AI algorithms to design better medicine, faster. But ...
Posted by Michael Wonder on 13 Feb 2024
The threat of fungal infections is growing. Why is it so hard to make new drugs?
11 February 2024 - Last summer, the FDA denied an application for a new anti-fungal drug called olorofim, sending it back ...
Posted by Michael Wonder on 07 Feb 2024
FDA and EMA launch parallel scientific advice pilot program for complex generics
7 February 2024 - CDER’s Office of Generic Drugs and the EMA launched a voluntary pilot program to facilitate concurrent discussions ...
Posted by Michael Wonder on 04 Feb 2024
Addressing the challenge of common chronic diseases — a view from the FDA
3 February 2024 - Of the 10 most common causes of death in the United States, 7 are chronic diseases: ...
Posted by Michael Wonder on 12 Nov 2023
MedChem a game changer in identifying lifesaving new drugs
8 November 2023 - The Australian Government is ensuring the next generation of lifesaving drugs and world-class medical treatments can be ...
Posted by Michael Wonder on 07 Nov 2023
Germany, Belgium and France among those hit hardest as Commission’s Pharma-legislation proposals risk Europe losing a third of its share of global R&D by 2040
6 November 2023 - The European Federation of Pharmaceutical Industries and Associations (EFPIA) is publishing new research which assesses the ...
Posted by Michael Wonder on 29 Sep 2023
FDA launches pilot program to help further accelerate development of rare disease therapies
29 September 2023 - Today, the US FDA is taking steps to help further accelerate the development of novel drug and ...
Posted by Michael Wonder on 23 Jul 2023
How a drug maker profited by slow walking a promising HIV therapy
22 July 2023 - Gilead delayed a new version of a drug, allowing it to extend the patent life of a ...
Posted by Michael Wonder on 07 Jul 2023
A priority review voucher program to fuel generic drug development
6 July 2023 - Millions of Americans report that they are unable to fill their prescriptions or are not taking their ...
Posted by Michael Wonder on 06 Jun 2023
FDA announces additional steps to modernise clinical trials
6 June 2023 - Agency requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial ...
Posted by Michael Wonder on 04 Apr 2023
New features further strengthen Priority Medicines scheme (PRIME)
4 April 2023 - The EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to ...
Posted by Michael Wonder on 22 Mar 2023
Drug repurposing during the COVID-19 pandemic: lessons for expediting drug development and access
20 March 2023 - The COVID-19 pandemic created a large, sudden unmet public health need for rapid access to safe and ...
Posted by Michael Wonder on 05 Mar 2023
Replacing RCTs with real world data for regulatory decision-making: a self-fulfilling prophecy?
2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials for closing knowledge gaps ...
Posted by Michael Wonder on 23 Feb 2023
FDA continues important work to advance medical products for patients with rare diseases
23 February 2023 - Patients with rare diseases are experts in their health condition. They provide a unique perspective, and ...