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

Kadcyla Manufacturing Review Was A Production In Itself

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The complex manufacturing required by Genentech’s antibody-drug conjugate trastuzumab emtansine pushed FDA’s review two months past the agency’s internal action timetable, required four review teams from three CDER offices and produced a veritable blizzard of information requests. But is that level of intensity sustainable as the expanding ADC pipeline matures?

You may also be interested in...



Genentech’s Cancer Product Line Expands, As Do Its Post-Market Manufacturing Obligations

Genentech appears to be having significant manufacturing problems for some of its new cancer therapies. FDA hasn’t taken enforcement action yet, but the agency has delayed two approvals and tied them to post-market requirements to address QC issues.

Gilead’s Immunomedics Buy: Five Things To Worry About

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

Keeping Track: Terlipressin Falls Short Of US FDA Approval; Novel NDAs From Pfizer And Apellis; New BTDs For Sanofi, BeyondSpring

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Topics

Related Companies

UsernamePublicRestriction

Register

MT125529

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