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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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Latest From Sue Sutter

Pediatric Exclusivity For ‘Deemed’ Biologics Needs Clarity, Industry Tells US FDA

Draft guidance says unexpired pediatric exclusivity would continue to apply to a deemed 351(a) BLA on March 23, 2020, but industry says differences in how pediatric exclusivity operates under the statutory frameworks governing drugs and biologics could result in the loss of some marketing protection.

Biosimilars Biologics

Insulin Maker Lilly Seeks US FDA Assurances On ‘Authorized Biologics’

Sponsor of an NDA-approved protein product subject to March 2020 ‘transition provisions’ should be able to seek biosimilar licensure of that same product without surrendering its ‘deemed’ 351(a) approval, company says, also requesting that FDA clarify parameters for ‘branded biosimilars.’

Biologics Biosimilars

Generic Sensipar: Cipla Challenges Legality of Amgen/Teva Patent Settlement

Cipla, which previously settled with Amgen, alleges Sensipar's formulation patent is currently unenforceable due to ‘patent misuse,’ and brand sponsor’s deal with Teva following a brief generic launch violates federal antitrust law and California state law.

Generic Drugs Intellectual Property

Janssen’s Esketamine Gets US FDA Panel Endorsement, But With Pricing, Access And Diversion Concerns

Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.

Advisory Committees Drug Review

Janssen’s Esketamine Needs Better Defined REMS, US FDA Panel Says

Advisory committee overwhelmingly endorses approval for patients with treatment-resistant depression but says proposed Risk Evaluation and Mitigation Strategy needs refinement, including clarifying the types of facilities where the drug will be administered.

Advisory Committees Drug Review

Generic Advair's Labeling Variation Stems From Permissible Design Differences, US FDA Says

Patient instructions for use of Mylan’s fluticasone/salmeterol generic are noticeably different from GSK’s reference listed drug but fall within the ‘different manufacturers’ exception to the ‘same labeling’ requirement.

Generic Drugs Drug Approval Standards
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