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.

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

Lumicell’s Cancer Imaging Drug Faces Clinical Meaningfulness, Anaphylaxis Risk Questions At FDA Panel

Executive Summary

US FDA advisory committee briefing documents say drug-device combo Lumisight (pegulicianine) is effective at picking up cancer but it is not clear whether that translates to patient benefit.

You may also be interested in...



‘Incremental’ Benefit Of Lumicell’s Cancer Imaging Drug Outweighs Manageable Risk, FDA Panel Says

Most advisory committee members supported approval of the breast cancer imaging product, but indicated labeling and advertising should be carefully crafted to avoid overhyping the likelihood patients experience a clinical benefit.

Ivermectin Settlement Brings Relief And Worry For US FDA Communications

The FDA’s decision to end litigation challenging an agency communication that tried to tackle COVID-19 misinformation leaves an appeals court opinion in place that could haunt it later. But continuing to fight the case could have left the agency in a far worse position.

Califf Suggests Congress ‘Tighten Up Laws’ To Address Orange Book Abuses

US FDA Commissioner repeats longstanding FDA policy that the agency doesn’t have much power to address frivolous patent listings in the Orange Book, but seems to support Congress providing more authority.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS149890

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