Blog
RSS FeedPosted by Michael Wonder on 26 Jun 2023
Revise pharmaceutical legislation, or long-term access to medical breakthroughs for Europeans will be harmed
22 June 2023 - Yesterday, the newly elected Presidency team of the European Federation of Pharmaceutical Industries and Associations convened ...
Posted by Michael Wonder on 22 Jun 2023
PhRMA sues Biden administration over Medicare drug price negotiations
21 June 2023 - The pharmaceutical industry’s largest lobbying group on Wednesday filed a lawsuit challenging provisions in the Biden ...
Posted by Michael Wonder on 21 Jun 2023
Novo Nordisk takes actions to help protect US patients from unlawful sales of non-FDA approved medicines claiming to contain semaglutide
20 June 2023 - Initiating legal proceedings against medical spas, weight loss or wellness clinics, and compounding pharmacies to cease and ...
Posted by Michael Wonder on 20 Jun 2023
BMS joins Merck in challenge to Medicare price negotiation
20 June 2023 - Bristol-Myers Squibb has filed a lawsuit against the US Government that aims to block the drug ...
Posted by Michael Wonder on 15 Jun 2023
New Alzheimer’s drug is a problem for FDA’s pass-fail approach
15 June 2023 - The FDA is slated to soon give full approval to Leqembi, a new medicine for Alzheimer’s disease ...
Posted by Michael Wonder on 15 Jun 2023
FDA should reject accelerated approval of gene therapy SRP-9001
15 June 2023 - The US FDA should reject the accelerated approval of the gene therapy SRP-9001 (Sarepta Therapeutics) for ...
Posted by Michael Wonder on 13 Jun 2023
US Chamber of Commerce sues over Government's drug pricing power
9 June 2023 - The U.S. Chamber of Commerce on Friday sued the federal government, challenging a new law that for ...
Posted by Michael Wonder on 12 Jun 2023
Is Canada missing out? An assessment of drugs approved internationally between 2016 and 2020 and not submitted for Health Canada review
12 June 2023 - One-third of the new active substances approved in the United States and Europe between 2016 and ...
Posted by Michael Wonder on 10 Jun 2023
A review of labeling based on patient reported outcome endpoints for new oncology drugs approved by the EMA (2017-2021)
9 June 2023 - A review of new oncology indications approved by the EMA for 2012-2016 showed that 33% of new ...
Posted by Michael Wonder on 09 Jun 2023
Considering tomorrow’s patients in today’s drug approvals
8 June 2023 - Responding to pressure from patients seeking access to promising new medicines, drug regulatory agencies have worked over ...
Posted by Michael Wonder on 08 Jun 2023
Congress’ misguided plan to ban QALYs
8 June 2023 - Paying for health care is a challenge for many Americans, but the House of Representatives is on ...
Posted by Michael Wonder on 08 Jun 2023
Merck sues to stop the IRA’s ‘extortion’
7 June 2023 - The drug maker makes a compelling case that the Medicare price control bill violates the Constitution. ...
Posted by Michael Wonder on 06 Jun 2023
Merck sues HHS over drug negotiation, claims program ‘tantamount to extortion’
6 June 2023 - In its suit, the drug giant claims that Medicare negotiation program is unconstitutional. ...
Posted by Michael Wonder on 04 Jun 2023
TGA supports MHRA’s new international recognition framework for medicines
2 June 2023 - As a trusted regulatory partner, TGA is committed to support the new international recognition framework that MHRA ...
Posted by Michael Wonder on 01 Jun 2023
Inflation Reduction Act undermines cancer medicine development
1 June 2023 - The price setting provisions in the Inflation Reduction Act acutely impact the research and development (R&D) ...