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RSS FeedPosted by Michael Wonder on 24 Nov 2021
Germany's Government to be eyes backdated drug price cuts
24 November 2021 - Germany's prospective three-party government plans to cut prices retroactively for recently-launched prescription drugs to keep health ...
Posted by Michael Wonder on 24 Nov 2021
A vision for use of real world evidence in EU medicines regulation
24 November 2021 - Enabling the use of real world evidence and establishing its value for regulatory decision-making on the development, ...
Posted by Michael Wonder on 24 Nov 2021
The FDA's dysfunction is a public health crisis of its own
22 November 2021 - Earlier this month, President Biden tapped Dr. Robert Califf to lead the FDA. ...
Posted by Michael Wonder on 24 Nov 2021
COVID-19 vaccine indemnity
24 November 2021 - The Australian Government is reducing the claim threshold of the no fault COVID-19 Vaccine Claims Scheme to ...
Posted by Michael Wonder on 24 Nov 2021
Review of real world evidence and patient reported outcomes
24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported ...
Posted by Michael Wonder on 24 Nov 2021
Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies
23 November 2021 - Robert Califf, President Biden’s choice to lead the FDA, earned $2.7 million as an executive at ...
Posted by Michael Wonder on 24 Nov 2021
FDA nomination slips after Biden admin fails to send papers to Congress
23 November 2021 - The delay means that Califf is now unlikely to get a confirmation hearing until mid-December at the ...
Posted by Michael Wonder on 23 Nov 2021
Why is aducanumab priced at $56,000 per patient? Lessons for drug pricing reform.
20 November 2021 - Aducanumab’s price can inform the drug pricing policy debate because it responds to key features of ...
Posted by Michael Wonder on 23 Nov 2021
Update on regulatory review of aducanumab in the European Union
17 November 2021 - Biogen and Eisai announced today an update on the on-going review of the marketing authorisation application ...
Posted by Michael Wonder on 16 Nov 2021
Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: a comparison with standard approved cancer drugs
15 November 2021 - Cancer drugs are increasingly approved through expedited regulatory pathways including the European conditional marketing authorisation. ...
Posted by Michael Wonder on 15 Nov 2021
New FDA chief will face COVID woes and calls for drug approval reform
12 November 2021 - After long delay, US President Joe Biden picks Robert Califf to once again head the US FDA. ...
Posted by Michael Wonder on 15 Nov 2021
It's time for Congress to get Medicare drug pricing reform right
15 November 2021 - After a three-year debate and delay in delivering patients much-needed relief from high out-of-pocket prescription drug costs, ...
Posted by Michael Wonder on 15 Nov 2021
Califf has lots of unfinished FDA business
15 November 2021 - Robert Califf, whom President Biden picked to lead the US. FDA, does not have much to show ...
Posted by Michael Wonder on 14 Nov 2021
Drug pricing debate redux — should cost effectiveness analysis be used now to price pharmaceuticals?
13 November 2021 - The idea of permitting the government to negotiate pharmaceutical prices raises a question about the basis for ...
Posted by Michael Wonder on 14 Nov 2021
Regulating drug prices while increasing innovation
13 November 2021 - To save money on drugs while encouraging high-value pharmaceutical innovation, we need to better reward value, increase ...