More Me-Too Drugs Please, FDA’s Jenkins Asks Industry
Executive Summary
FDA’s top new drug official called out industry’s innovation model, noting that major primary care markets are being left underserved as sponsors focus on precision medicine and rare diseases.
You may also be interested in...
Lilly’s Late-Stage CNS Pipeline Bare Following Edivoxetine Failure
Depression candidate edivoxetine fails in three Phase III studies, marking a third recent blow to Lilly’s neuroscience pipeline efforts.
What Innovation Crisis? First-In-Class Drug Approvals Stable For Almost 25 Years, FDA Says
An FDA study evaluating NMEs by level of innovation finds level first-in-class approvals to be consistent, and approvals after the study period reinforce “encouraging” findings. Analysis says new metric should be basis for assessment of programs created by FDASIA to speed development of innovative products.
China-US Divide Deepens On Covid Vaccines, Azar Taiwan Visit
China has shown willingness to go tit-for-tat in its bilateral disputes with the US and the latest comments from US officials show an underlying distrust over clinical data and vaccines safety in China, raising fresh concerns just when collaboration is needed to accelerate availability of the first vaccines in the global pandemic.
Need a specific report? 1000+ reports available
Buy Reports