Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 17 Aug 2024
Medicare’s drug price talks are about to get more heated
16 August 2024 - Drug makers and officials are fighting over many aspects of the now-annual negotiations. ...
Posted by Michael Wonder on 17 Aug 2024
Commemorating the second anniversary of the Biden-Harris Lower Cost Prescription Drug Law
16 August 2024 - The Inflation Reduction Act is saving Americans millions in lower prescription drug costs and making health ...
Posted by Michael Wonder on 17 Aug 2024
Negotiating for lower drug prices works, saves billions
15 August 2024 - In a historic moment that will help lower prescription drug prices for millions of people across America, ...
Posted by Michael Wonder on 14 Aug 2024
The FDA should withdraw approval of more than 400 tainted medicines
12 August 2024 - When the FDA learned that a testing facility in India had submitted fraudulent data for more ...
Posted by Michael Wonder on 08 Aug 2024
Medicare finalises reimbursement rule for breakthrough medical devices
7 August 2024 - The Centers for Medicare and Medicaid Services has finalised its rule easing reimbursement for medical device ...
Posted by Michael Wonder on 04 Aug 2024
Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy
1 August 2024 - Over the past decades, US Congress enabled the US FDA to facilitate and expedite drug development for ...
Posted by Michael Wonder on 04 Aug 2024
How to tell if Biden drove a hard bargain in Medicare drug price negotiations
30 July 2024 - The deadline for announcing how much Medicare lowered drug prices in the first year of negotiation is ...
Posted by Michael Wonder on 03 Aug 2024
Novo Nordisk latest drugmaker to face setback in IRA litigation
1 August 2024 - A federal court backed the Biden administration’s Medicare drug price negotiation program on Wednesday, the latest ...