Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 25 Jul 2024
Drug middlemen push patients to pricier medicines, House probe finds
23 July 2024 - Findings from the House Oversight investigation add to criticism that pharmacy-benefit managers are driving up drug spending. ...
Posted by Michael Wonder on 25 Jul 2024
Switzerland’s drug approval process lags behind Europe
24 July 2024 - According to a recent study, medicines are approved on average 249 days later in Switzerland than by ...
Posted by Michael Wonder on 24 Jul 2024
Jeff Shuren, medical devices head at FDA, to leave the agency
23 July 2024 - Jeffrey Shuren, longtime chief regulator of medical devices at the FDA, announced to staff on Tuesday ...
Posted by Michael Wonder on 24 Jul 2024
This gene therapy may not work. So why did the FDA fully approve it?
22 July 2024 - The agency has repeatedly neglected its obligation to ensure that drugs are effective. ...
Posted by Michael Wonder on 24 Jul 2024
Fixing the reimbursement and coverage divide between ‘breakthrough’ drugs and medical devices
23 July 2024 - The FDA designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and ...