Sue primarily covers US drug, biologic, vaccine and biosimilar regulation and policy across therapeutic areas, with an emphasis on advisory committee reviews, FDA approvals and use of expedited review pathways. Sue has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the Citeline umbrella, including Pink Sheet and Scrip. Previously she worked as an editor for Mealey's Litigation Reports (now part of Lexis-Nexis), writing about asbestos, toxic tort and fen-phen litigation. She grew up in South Jersey and spends her free time watching youth sports, gardening, walking and hiking, although she'd rather be at the beach.
Latest from Sue Sutter
Lexicon’s Zynquista: Negative Adcomm Vote In Type 1 Diabetes Includes Support For Revised Indication
Some panelists favored use in T1D patients with mild chronic kidney disease, even though that was not the original indication Lexicon proposed, which was rejected in an 11-3 vote.
The Pharmacy Compounding Advisory Committee unanimously voted to add hydroxyprogesterone caproate products for reducing the risk of recurrent singleton spontaneous preterm birth to the Withdrawn or Removed List under sections 503A and 503B of the Food, Drug and Cosmetic Act.
The Zynquista application in type 1 diabetes received a complete response letter in 2019. This time, Lexicon seeks approval for patients with T1D and chronic kidney disease. FDA review staff said making definitive conclusions about the magnitude of glucose-lowering effects in this population is difficult, and the risk of diabetic ketoacidosis remains.
Multiple and repeated complaints will sharpen the Office of Prescription Drug Promotion’s focus on an advertisement, Director Catherine Gray said, while Foley Hoag partner August Horvath said the self-regulatory NAD process is best suited to complaints that lack a ‘great scientific basis’ for objecting.
Lyfgenia and Zynteglo comprise complex mixtures of transduced cells that represent different active ingredients, the company said in administrative appeals to the FDA. Two lawmakers also raised bipartisan concerns about the agency’s decision on the voucher request for the sickle cell disease treatment.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.