Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

Menu

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
My View
Tags:
Quality Manufacturing Complete Response Letters

Immunomedics Dodges Manufacturing Site Specifics In Quest For Cancer Breakthrough Approval

  • News

Executive Summary

Biotech firm chooses words carefully to wind its way through site inspection findings and CMC review concerns in hopes of winning its first FDA approval for a breakthrough breast cancer treatment.

You may also be interested in...



Good News For Immunomedics' Triple Negative Breast Cancer Trial

A Phase III trial testing the antibody-drug conjugate sacituzumab govitecan was stopped early for efficacy, boding well for the BLA pending at the US FDA.

Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs

The latest oncology development news and highlights from our US FDA Performance Tracker.

Keeping Track: FDA's Review Actions Carry On During Shutdown

The latest drug development news and highlights from our US FDA Performance Tracker.

Table

View full table

Related Content

Pink Sheet
Pink Sheet

Topics

Related Companies

Tags:
Quality Manufacturing Complete Response Letters
Latest Headlines

China’s Public Payer Wants To Define Innovative Drugs As Those With ‘Novel Benefits’

Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116

Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length

German HTA Queries Polivy Benefits Amid Lack Of Evidence

See All
UsernamePublicRestriction

Register

PS124756

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

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