The Drug Development Letter

The Drug Development Letter

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How to read and interpret a cancer clinical trial
A concise, step by step guide
 • 
Vinay Prasad
6
Eli Lilly's Court Victory: Dutch Agency Must Reevaluate Abemaciclib Amid Controversy
Eli Lilly’s court appeal to override the negative assessment of abemaciclib in the Netherlands
 • 
Sahar van Waalwijk
20
Relapsed cancer patients die so asymptomatic pre-cancer patients can go on trial
Is this tradeoff really so bleak?
 • 
Vinay Prasad
1
Why Should a Top FDA Official Unilaterally Approve an Expensive Gene Therapy? The Case of Elevidys.
Peter Marks, the director of the Center for Biologics Evaluation and Research within the Food and Drug Administration (FDA), unilaterally approved…
 • 
Vinay Prasad
 and 
Timothée Olivier
9
The ‘Duck Test’ for Huey, Dewey and Louie: the legal case on CDK4/6 inhibitors
Me-too drugs (drugs with the same mode of action for the same indication) are generally beneficial to society as they provide variation, choice and…
 • 
Sahar van Waalwijk
 and 
Hans Westgeest
Home-Grown CAR-T Cells: A Blessing or a Threat?
Biotech's pushback against the development of academic CAR-T cell therapy in the Netherlands.
 • 
Sahar van Waalwijk
1
How to read and interpret Kaplan Meier Curves
Slides available for subscribers
 • 
Vinay Prasad
"Surrogate end points in oncology: the speed-uncertainty trade-off from the patients' perspective"
This is my new paper out in Nature Reviews Clinical Oncology
 • 
Vinay Prasad
Debate over pembrolizumab dosing gives rise to a national guidance on de-escalation strategies and off-label use
"You may wonder why most dose optimisation and de-escalation studies come from the Netherlands"
 • 
Sahar van Waalwijk
2
Did pembrolizumab improve survival in patients with locally advanced cervical cancer due to poor access to post-protocol care?
We recently published our analysis in the journal Cancer, explaining why we believe an trial testing pembrolizumab in this setting – KEYNOTE-A18 …
 • 
Bart Penninx
, 
Michael Samson
, and 
John-John Schnog
4
The CABINET study
100% NIH funded; 100% placebo controlled
 • 
Vinay Prasad
3
19:17
Excessive Drug Price Leads to Hefty Fine for Company in the Netherlands
Why was a company fined €17 million for excessive pricing?
 • 
Sahar van Waalwijk
1
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