Blog
RSS FeedPosted by Michael Wonder on 24 Dec 2024
HHS announces cost savings for 64 prescription drugs thanks to the Medicare Prescription Drug Inflation Rebate Program established by the Biden-Harris Administration’s lower cost prescription drug law
20 December 2024 - Under the Inflation Reduction Act, some people with Medicare will pay less for some Part B ...
Posted by Michael Wonder on 22 Dec 2024
Givinostat conditionally approved to treat patients with Duchenne muscular dystrophy
20 December 2024 - The MHRA has today granted a conditional marketing authorisation for the medicine givinostat (Duvyzat) to treat Duchenne ...
Posted by Michael Wonder on 14 Dec 2024
Alofisel withdrawn from the EU market
13 December 2024 - Benefit of treatment used in Crohn’s disease no longer demonstrated. ...
Posted by Michael Wonder on 13 Dec 2024
UK MHRA grants innovation passport designation to ILiAD Biotechnologies BPZE1 next generation intranasal pertussis vaccine
4 December 2024 - ILiAD Biotechnologies today announced that the UK MHRA has granted Innovation Passport designation to BPZE1, the leading ...
Posted by Michael Wonder on 13 Dec 2024
CDER establishes new Center for Real World Evidence Innovation
12 December 2024 - Today, the US FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center ...
Posted 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 ...