Keeping Track: Cardio, Antibiotic Approvals Put FDA Over Last Year's Novel Drug Count
Executive Summary
The latest drug development news and US FDA highlights from our Performance Tracker.
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Deal Watch: Neos Says ‘Thanks, No Thanks’ To Repeated PDL Offer
Daiichi teams with Glycotope on an antibody-drug conjugate for cancer, while Alector will partner with AbbVie to research antibody targets for Alzheimer’s disease.
Keeping Track: A Burst of CRLs and BTDs, A Busy Week Of Submissions And Another Approval For Soliris
The latest drug development news and highlights from our US FDA Performance Tracker.
Patient Experience Data May Require Separate Label, Genentech Suggests
US labeling for Genentech's Rituxan Hycela appears to have broken new ground with a 'Patient Experience' section describing summary data from a patient preference study; however, the company's global head of outcomes research says large volumes of patient-centric data would be difficult to reflect within the current labeling framework.