Blog
RSS FeedPosted by Michael Wonder on 12 Apr 2022
Prospective measures to combat rising drug prices in Germany
13 April 2022 - This article provides an overview of potential tools being explored in Germany by Health Insurance Funds to ...
Posted by Michael Wonder on 12 Apr 2022
It’s time to fix the FDA by breaking it up
11 April 2022 - A new investigation about the agency’s failures underscores the need for a separate agency to keep our ...
Posted by Michael Wonder on 11 Apr 2022
Drug pricing with evidence development
11 April 2022 - The policy controversy surrounding aducanumab for Alzheimer disease has shifted from the FDA, which authorised the ...
Posted by Michael Wonder on 11 Apr 2022
A review of patient reported outcome labelling of FDA approved new drugs (2016-2020): counts, categories and comprehensibility
8 April 2022 - A review of new drug approvals by the U.S. FDA for 2006 to 2015 showed that approximately ...
Posted by Michael Wonder on 11 Apr 2022
Alzheimer's drug makers seek accelerated FDA review despite U.S. coverage decision
8 April 2022 - Eisai and Eli Lilly on Friday said they still plan to seek accelerated U.S. approval for ...
Posted by Michael Wonder on 10 Apr 2022
‘Precedents are important’: Aduhelm coverage restrictions could shape the future of accelerated approval
9 April 2022 - Whither accelerated approval? ...
Posted by Michael Wonder on 09 Apr 2022
Joint statement from CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner Robert M. Califf on ensuring access to safe and effective treatments
8 April 2022 - Ensuring the availability of innovative interventions for people is a shared priority for both the CMS and ...
Posted by Michael Wonder on 06 Apr 2022
Some hoped FDA approval of Pfizer's COVID vaccine would convince unvaccinated Americans. It didn't, study finds.
6 April 2022 - After the Food and Drug Administration approved Pfizer-BioNTech’s COVID-19 vaccine in August, public health experts were ...
Posted by Michael Wonder on 06 Apr 2022
U.S. FDA aims to decide on strain selection for COVID boosters by June
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
Posted by Michael Wonder on 06 Apr 2022
ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
6 April 2022 - The European Centre for Disease Prevention and Control and EMA’s COVID-19 task force have concluded that ...
Posted by Michael Wonder on 05 Apr 2022
FDA updates sotrovimab emergency use authorisation
5 April 2022 - Sotrovimab is no longer authorised to treat COVID-19 in any U.S. region due to increases in ...
Posted by Michael Wonder on 05 Apr 2022
Watchdog urged to probe McKinsey over work with FDA, opioid manufacturers
5 April 2022 - The consulting firm was getting paid by opioid makers while working for the FDA. ...
Posted by Michael Wonder on 02 Apr 2022
Califf admits controversy over FDA’s Alzheimer’s drug decision impacted experts’ trust in the agency
31 March 2022 - Robert Califf, the new head of the FDA, admitted Thursday that the agency’s controversial approval of ...
Posted by Michael Wonder on 31 Mar 2022
EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
31 March 2022 - EMA, in collaboration with the European Organisation for Research and Treatment of Cancer, has launched the Cancer ...
Posted by Michael Wonder on 30 Mar 2022
FDA officials aim to stop misuse of the term ‘digital biomarker’
29 March 2022 - While a lot of researchers claim they are capturing digital biomarker data, they may in fact be ...