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US FDA Pushes Back On Proposal For Early Clinical Designations To Support Higher Reimbursement Decisions

Breakthrough, RMAT designations signal clinical potential and are not intended to have reimbursement impact after approval, FDA says. 
Review Pathway Reimbursement

The Eteplirsen Precedent: No Denying It – So Let’s Define It

US FDA allowing Sarepta to seek accelerated approval for follow-on DMD agent – following 'precedent' set by eteplirsen. Now the new challenge is to define exactly what that precedent is.

Drug Approval Standards Drug Review

Refining A Controversial Endpoint: Sarepta Banking On Dystrophin Levels For Golodirsen Approval In DMD

While glodirsen did show higher levels of dystrophin production than eteplirsen did, increase is still unlikely to satisfy US FDA reviewers who disagreed with Janet Woodcock's decision to grant accelerated approval to eteplirsen.
Drug Approval Standards Drug Review

US FDA Eliminating 'Sub-Indications' From Inflammatory Bowel Disease Labels

Claims such as induction of clinical remission will now be placed in the clinical studies section for new IBD approvals.

Gastrointestinal Drug Review

Accelerated Approval: US FDA Defends Size Of Premarket Safety Databases, Confirmatory Endpoints

Taking on critics who say it is too quick to award accelerated approval based on surrogate endpoints and limited safety data, agency's 25-year review shows cancer drugs receiving accelerated approval generally have twice the amount of safety data as efficacy, and more than half have confirmed clinical benefit after approval.

Drug Approval Standards Review Pathway

PRIME Dry Spell Ends As EMA Takes On Eye Disease Gene Therapy

The first designation of 2018 under the European Medicines Agency’s PRIME scheme has gone to an advanced therapy for patients with the severe eye disorder, achromatopsia. In the meantime, most PRIME applications are still getting rejected.

Review Pathway Research & Development

ANDA Pre-Submission Meetings A 'Challenge' To Integrate Into Development Timelines

US FDA officials appears worried about workload created by product development and pre-submission meetings for complex generics.
Generic Drugs Review Pathway

Bumper Number Of 'Oral Explanations' Due At CHMP Meeting

An unusually large number of companies are due to appear this week before the European Medicines Agency’s key advisory panel, the CHMP, to answer questions about initial marketing authorization applications or indication extension requests. The CHMP has questions regarding nine different products.

Europe Regulation

Two Hopefuls And A ‘No’: EMA Decisions On Accelerated Access

Regeneron and Shire should find out this week whether the European Medicines Agency will agree to fast-track its review of their products.

Drug Review Europe
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