John Jenkins made several shocking comments about Center for Drug Evaluation and Research Director Janet Woodcock's behavior in the run up to the controversial approval of Sarepta Therapeutics Inc.'s Exondys 51, including that he worried about leaving the Office of New Drugs in her hands upon his retirement.
Woodcock's 'Bias' In Sarepta Case Made Jenkins Worry About Future Drug Reviews
In memo to then-Commissioner Califf during review of Sarepta's Exondys 51, Jenkins wrote that he was concerned about leaving OND in hands of CDER director upon his retirement.
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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.
Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.