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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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Insmed's Amikacin Has US FDA Questioning Microbiological Endpoint Vs. Clinical Benefit

Whether converting positive sputum culture to negative will lead to an improvement in how a person feels, functions or survives is at the heart of agency’s review of Insmed’s amikacin liposome inhalation suspension for accelerated approval in mycobacterial lung disease.

Advisory Committees Drug Review

Insmed’s Amikacin Moves Closer To US Market In Refractory Lung Disease

FDA panel's recommendation that liposome inhalation suspension be labeled only for refractory nontuberculous mycobacterial lung disease and not first-line use aligns with analyst expectations; panel cites lack of clinical studies in treatment-naive patients and adverse event profile as reasons for limiting drug to patients with limited or no treatment options.

Infectious Diseases Respiratory

US FDA’s First Competitive Generic Therapy Approval Comes With A Twist

Apotex’s potassium chloride oral solution is eligible for 180-day exclusivity under new expedited pathway even though Amneal’s generic referencing same product was approved three weeks earlier; Amneal's continued marketing will not be blocked by Apotex’s exclusivity, which is forfeited if it fails to launch within 75 days.

Approvals Generic Drugs

Sensipar Generics: US Court Victory, FDA Approval Position Piramal For Launch

Just days after Piramal was one of three generic drug sponsors found not to have infringed a Sensipar formulation patent, FDA approved company’s ANDA, threatening Amgen’s de facto exclusivity on the blockbuster calcium-sensing receptor agonist.

Generic Drugs Intellectual Property

Insmed’s Amikacin Gains US FDA Panel Nod For Refractory Lung Disease

But advisory committee recommends against sponsor's broader indication that would include first-line use in adults with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex; panel narrowly endorses surrogate endpoint of sputum culture conversion.

Advisory Committees Drug Review

Insmed’s Amikacin Faces US FDA Questions On Surrogate Endpoint, Target Population

Amikacin liposome inhalation suspension seeking accelerated approval to treat nontubercuolous mycobacterial lung disease caused by Mycobacterium avium complex in adults but has only studied patients with refractory disease; agency also wants its advisory committee to opine on confirmatory trial design.

Advisory Committees Drug Review
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