Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

In Brief

This article was originally published in The Gold Sheet

Executive Summary

Question-based review, or QbR, could spread from generics to new drugs. And that’s the way the patent crumbles: FDA’s new tablet-scoring guidance.

You may also be interested in...



FDA’s Tablet Scoring Final Guidance Requires Generics To Be Same As Brand

Generic industry concerns that scoring conventions could create barriers to entry did not win out in final tablet scoring guidance; FDA says to contact it if the scoring convention is patent protected.

AbbVie/Allergan Merger Edges Closer To FTC Clearance

AstraZeneca will reacquire Allergan's investigational IL-23 inhibitor brazikumab, and Nestle is to buy its GI drug Zenpep, which had nine-month revenue of $208m.

Another Sterilization Plant Closes For Upgrades; FDA Monitoring Situation For Device Shortage

The US agency is engaged with an ethylene oxide (EtO) sterilizer in Illinois that has temporarily closed to determine if there are any potential risks to the medical device supply chain. While the plant shut down about a month ago, regulators have only recently been made aware of the decision, which resulted from a law passed last year by the state legislature.

UsernamePublicRestriction

Register

PS000760

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel