Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 27 Mar 2024
Patient advocates clash over wisdom of ‘approving drugs faster and faster’
26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...
Posted by Michael Wonder on 23 Mar 2024
Deliberations at the CHMP regarding the marketing authorisation application in the EU for lecanemab have been rescheduled due to procedural reasons at the EMA
22 March 2024 - Eisai announced today that the oral explanation scheduled for 19 March at the CHMP for lecanemab, ...
Posted by Michael Wonder on 07 Mar 2024
Pharmaceutical reform agreement review report
6 March 2024 - The Department of Health and Aged Care has conducted a review of Pharmaceutical Reform Agreements (PRAs), to ...
Posted by Michael Wonder on 07 Mar 2024
Biden says Medicare should negotiate prices for at least 50 drugs each year, up from a target of 20
6 March 2024 - That proposal is one of several new health care policy plans Biden will outline during his State ...
Posted by Michael Wonder on 07 Mar 2024
Early impact of the Inflation Reduction Act on drug discovery
6 March 2024 - Despite the concerns of the biopharma industry, the Inflation Reduction Act has been enacted and with it, ...
Posted by Michael Wonder on 05 Mar 2024
Drug makers send counter offers for US Medicare price negotiations, Biden says
4 March 2024 - The manufacturers of 10 high cost drugs selected for the US Medicare program's first-ever pricing negotiations ...