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Can You Still Use Surrogate Markers In A Crowded Drug Class? Sollpura Panel Recommends BMI, Weight Endpoints

Executive Summary

The troubles that Alnara Pharmaceuticals has had with its application for Sollpura (liprotamase) for exocrine pancreatic insufficiency signal the challenges that developers of other drugs in crowded classes may face at FDA.

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In A Manufacturing Dispute With FDA, Can A Sponsor Get Help From An Advisory Committee?

As biosimilars loom on the horizon and a number of innovator biologics face the prospect of having to switch production facilities to accommodate growing demand, the advisory committee review of Eli Lilly & Co.'s application for Sollpura illustrates the challenges that a sponsor may face if it disagrees with FDA about a manufacturing issue.

In A Manufacturing Dispute With FDA, Can A Sponsor Get Help From An Advisory Committee?

As biosimilars loom on the horizon and a number of innovator biologics face the prospect of having to switch production facilities to accommodate growing demand, the advisory committee review of Eli Lilly & Co.'s application for Sollpura illustrates the challenges that a sponsor may face if it disagrees with FDA about a manufacturing issue.

Sollpura's Future After No Vote From Panel Might Include More Trials, Adult Indication

FDA's Gastrointestinal Drugs Advisory Committee says in lopsided votes that Lilly's exocrine pancreatic insufficiency drug candidate Sollpura (liprotamase) lacks proof of efficacy.

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