Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 07 Oct 2024
Confirmatory trials of accelerated approval drugs — will imposing fines reduce delays?
5 October 2024 - In 1992, patient advocacy groups convinced the FDA to develop an accelerated approval program, which allowed new ...
Posted by Michael Wonder on 04 Oct 2024
Medicines regulators weigh hope and hype with new Alzheimer’s drugs
30 September 2024 - Swiss medicines regulator Swissmedic is expected to decide by the end of the year whether to approve ...
Posted by Michael Wonder on 04 Oct 2024
HHS releases final guidance for second cycle of historic Medicare drug price negotiation program
2 October 2024 - As part of the continued implementation of the Biden-Harris Administration’s historic prescription drug law, the Inflation Reduction ...
Posted by Michael Wonder on 03 Oct 2024
Improving efficiency of approval process for new medicines in the EU
2 October 2024 - EMA and the European medicines regulatory network are working to further improve efficiency in the assessment and ...
Posted by Michael Wonder on 26 Sep 2024
EMA recommends suspension of sickle cell disease medicine Oxbryta
26 September 2024 - The EMA’s CHMP has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta ...
Posted by Michael Wonder on 25 Sep 2024
PhRMA scores a small win in legal challenge to Medicare’s drug price negotiation
20 September 2024 - An appeals court revived the case and sent it back to a lower court in Texas. ...
Posted by Michael Wonder on 21 Sep 2024
FTC accuses drug middlemen of inflating insulin prices
20 September 2024 - Agency files lawsuit alleging firms profited from higher insulin prices. ...
Posted by Michael Wonder on 21 Sep 2024
Voucher program notches win as clock ticks
20 September 2024 - The FDA’s priority review voucher program for rare paediatric diseases is set to lapse on 30 September ...
Posted by Michael Wonder on 18 Sep 2024
The ICER developing special report for submission to CMS as part of public comment process on Medicare drug price negotiations
18 September 2024 - Report to reflect legislative specifications in the Inflation Reduction Act and subsequent CMS guidance regarding price ...
Posted by Michael Wonder on 18 Sep 2024
Oncology accelerated approvals are often based on non-comparative trials evaluating response rate
17 September 2024 - Most oncology products granted accelerated approval by the US FDA tend to rely on non-comparative single ...