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Sue Sutter

Senior Editor

Washington, D.C.
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.  She has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the umbrella of Informa Business Information, including Pink Sheet, “The Pink Sheet” DAILY, “The Tan 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.
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Cures Act Hiring Authority Expansion Could Help Recruitment Woes, US FDA's Sharpless Says

Acting commissioner says greater flexibility in hiring has 'a real potential to solve some of our problems,' although only about 40-50 people have been added to date; recruitment and retention were very much on the minds of the FDA’s leadership at the recent BIO annual meeting, where center directors spoke of the long-term damage caused by the five-week partial government shutdown.

FDA Gene Therapy

Data Standards: Technical ‘Postmortem’ Could Clarify US FDA Preferences, Industry Says

Feedback on application-specific data submission issues that vexed the agency but were not onerous enough to warrant a refuse-to-file letter would help inform future filings and reduce variation across sponsors, industry representatives say at meeting on analytical data standards.

 

Drug Approval Standards FDA

Sanofi’s Ameet Nathwani Brings Life Sciences R&D Expertise To The Digital Space

Nathwani talks to Scrip about his unique dual role as chief medical officer and chief digital officer, Sanofi’s approach to digital therapeutics, and major hurdles to turning the promise of such technologies into a reality for patients.

Digital Health Exec Chat

Cell/Gene Therapy Manufacturing Readiness Urged As A Condition For US Expedited Designation

Requiring that certain chemistry, manufacturing and controls conditions be satisfied before awarding breakthrough or regenerative medicine advanced therapy status would help ensure that the quality side of product development keeps pace with the clinical side, says Parexel's Mo Heidaran, a former CMC reviewer in the FDA’s biologics center.

Regenerative Medicine Gene Therapy

The Future Of US Biosimilars Litigation: Method-Of-Use Patents And ‘Dance’ Obligations

Expect plenty of litigation over what constitutes infringement of a method-of-use patent even when the protected indication is not found on a biosimilar’s labeling, a panel of legal experts said at the recent BIO meeting; another area of unsettled law is the extent to which a biosimilar sponsor has satisfied the information-exchange provisions of the BPCIA ‘patent dance.’

Biosimilars Intellectual Property

Amyloidosis Drug Competitors Can Coexist While Growing The Market, Alnylam CEO Says

The recent US FDA approval of three drugs – Alnylam’s Onpattro, Ionis’ Tegsedi and Pfizer’s tafamidis – in transthyretin-mediated amyloidosis means more opportunities to increase education and improve diagnosis in this rare disease, Alnylam CEO John Maraganore tells Scrip.

Reimbursement Rare Diseases
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