Blog
RSS FeedPosted by Michael Wonder on 30 May 2024
FDA use of “proxies” to expedite drug approvals not supported by evidence, analysis finds
28 May 2024 - In the world of drug development, there has been a recent movement to speed clinical trials of ...
Posted by Michael Wonder on 28 May 2024
The impact of proposed price regulations on new patented medicine launches in Canada: a retrospective cohort study
27 May 2024 - The Patented Medicine Prices Review Board (PMPRB), the agency that regulates the prices of patented medicines in ...
Posted by Michael Wonder on 23 May 2024
PMPRB report examines availability and pricing of new medicines
22 May 2024 - The Patented Medicine Prices Review Board (PMPRB) published the eighth edition of its annual Meds Entry Watch ...
Posted by Michael Wonder on 22 May 2024
Protecting Australians from unsafe compounding of replica weight loss products
22 May 2024 - The Albanese Government is acting to protect Australians from the risks posed by injecting potentially unsafe ...
Posted by Michael Wonder on 21 May 2024
Federal Trade Commission actions on prescription drugs (2000-2022)
20 May 2024 - The Federal Trade Commission’s oversight role in the pharmaceutical market is critical to the health of ...
Posted by Michael Wonder on 20 May 2024
Overall survival benefits of cancer drugs initially approved by the US FDA on the basis of immature survival data: a retrospective analysis
13 May 2024 - New cancer drugs can be approved by the US FDA on the basis of surrogate endpoints while ...
Posted by Michael Wonder on 14 May 2024
Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis
13 May 2024 - Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss ...
Posted by Michael Wonder on 30 Apr 2024
J&J, BMS lose challenges to US drug price negotiation program
29 April 2024 - A US judge on Monday rejected a challenge by Bristol Myers Squibb and Johnson & Johnson ...
Posted by Michael Wonder on 27 Apr 2024
A milestone in facilitating the development of safe and effective biosimilars
26 April 2024 - This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that ...
Posted by Michael Wonder on 25 Apr 2024
Bashing accelerated approval isn’t supported by the data
24 April 2024 - The FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and ...
Posted by Michael Wonder on 23 Apr 2024
New recommendations to strengthen supply chains of critical medicines
23 April 2024 - EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines ...
Posted by Michael Wonder on 23 Apr 2024
Associations between surrogate markers and clinical outcomes for non-oncologic chronic disease treatments
22 April 2024 - What is the strength of association between surrogate markers used as primary outcomes in clinical trials ...
Posted by Michael Wonder on 18 Apr 2024
COVID-19 vaccine strain updates: global regulators agree on timing and data requirements
17 April 2024 - International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...
Posted by Michael Wonder on 12 Apr 2024
Medicare drug price negotiations: policy implications of the first 10 drugs’ features
9 April 2024 - This article describes how CMS’s approach to implementing the negotiations will be shaped by the distinctive ...
Posted by Michael Wonder on 08 Apr 2024
EMA says it will consider conditional approval for NASH drugs using intermediate outcomes
5 April 2024 - The EMA said in a new reflection paper that it will consider granting conditional marketing approval ...