Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 Sep 2024
The sense and sensibility of sensitivity analyses
14 September 2024 - Clinicians and public health officials routinely make evidence-based decisions that affect patient and population level health. ...
Posted by Michael Wonder on 06 Sep 2024
US will still pay at least twice as much after negotiating drug prices
3 September 2024 - The US Government's first ever negotiated prices for prescription drugs are still on average more than ...
Posted by Michael Wonder on 06 Sep 2024
Advanz Pharma secures temporary suspension of the European Commission decision on the Ocaliva conditional marketing authorisation in Europe
5 September 2024 - Advanz Pharma today announces that the General Court of the European Union has temporarily suspended the European ...
Posted by Michael Wonder on 05 Sep 2024
Breakthrough therapies approved based on surrogate endpoints often lack post-marketing requirements
4 September 2024 - The use of surrogate markers to support drug approvals without requiring postmarketing studies can “hinder accurate ...
Posted by Michael Wonder on 25 Aug 2024
What the newly released Medicare prices for 10 drugs do and don’t tell us
16 August 2024 - CMS needs to beware of unintended consequences that might hamper patient access. ...