Blog
RSS FeedPosted by Michael Wonder on 08 Dec 2024
Autopsy of a drug withdrawal — the case of melphalan flufenamide
7 December 2024 - The accelerated approval pathway, which was established in 1992, has expedited approvals of drugs for serious and ...
Posted by Michael Wonder on 05 Dec 2024
Clearing dense drug patent thickets
27 November 2024 - Proposed reforms from the US Patent and Trademark Office and Congress could work in tandem to prevent ...
Posted by Michael Wonder on 03 Dec 2024
Preferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment
18 November 2024 - The extent to which patients with cancer are willing to accept uncertainty about the clinical benefit of ...
Posted by Michael Wonder on 03 Dec 2024
The trade-off between accelerated cancer drug approvals and patient preferences
18 November 2024 - Cancer care stands at a critical juncture where the urgency of rapid drug approvals must be balanced ...
Posted by Michael Wonder on 02 Dec 2024
‘We dodged a bullet’: biotech and pharma react to selection of Marty Makary for FDA commissioner
23 November 2024 - Many appear cautiously optimistic about Trump’s intended pick. ...
Posted by Michael Wonder on 01 Nov 2024
I’m the director of the Center for Medicare. Here’s how we executed the first round of drug price negotiation.
29 October 2024 - The historic Inflation Reduction Act of 2022 has fundamentally improved the affordability of and access to prescription ...
Posted by Michael Wonder on 21 Oct 2024
Gilead provides update on US indication for Trodelvy in metastatic urothelial cancer
18 October 2024 - Gilead Sciences today announced plans to voluntarily withdraw the US accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for ...
Posted by Michael Wonder on 18 Oct 2024
Government of Canada announces new appointment to the Patented Medicine Prices Review Board
17 October 2024 - Today, the Honourable Mark Holland, Minister of Health, announced a new appointment to the Patented Medicine ...
Posted by Michael Wonder on 18 Oct 2024
Update on regulatory review of lecanemab for early Alzheimer's disease in Australia
17 October 2024 - Eisai announced today that the TGA of Australia issued a public statement about the initial decision ...
Posted by Michael Wonder on 17 Oct 2024
TGA's decision to not register lecanemab (Leqembi)
16 October 2024 - The TGA has made the decision not to register lecanemab (Leqembi) for the treatment of patients ...
Posted by Michael Wonder on 17 Oct 2024
The science of biosimilars - updating interchangeability
18 October 2024 - Almost 15 years ago the US FDA was given the authority to approve biosimilars through the ...
Posted by Michael Wonder on 17 Oct 2024
Medicare’s first round of drug price negotiation - measuring success
16 October 2024 - The Federal Government has proven that it can navigate the difficult process of identifying drugs for price ...
Posted by Michael Wonder on 10 Oct 2024
Biden-Harris Administration Takes Next Step on Proposed Model to Lower Prescription Drug Costs for People with Medicare
9 October 2024 - Today, the US Department of Health and Human Services, through the Centers for Medicare & Medicaid Services, ...
Posted by Michael Wonder on 09 Oct 2024
Seizing opportunities in a changing medicines landscape
9 October 2024 - European medicines agencies network strategy to 2028 – launch of public consultation. ...
Posted by Michael Wonder on 09 Oct 2024
MHRA launches 2024/25 business plan with focus on enabling access to groundbreaking new technology while optimising delivery for all who need our services
7 October 2024 - The MHRA has today launched its ambitious new business plan for 2024/25, setting out the agency’s core ...