Scrip 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

Incyte’s US Approval For PD-1 Inhibitor Zynyz In MCC Draws Muted Response

Unlikely To Prove Competitive

Executive Summary

The US firm’s Zynyz has won accelerated approval for the treatment of first-line Merkel cell carcinoma, bouncing back from a prior regulatory setback, but its third-to-market status leaves it with the crumbs under the table in this orphan indication.

You may also be interested in...



Incyte Enters A Data-Rich Year On Path To Portfolio Diversification

Incyte’s Jakafi-dominated portfolio gained Opzelura as a second source of significant revenue in 2021. While further diversification has been limited, new and existing R&D assets may deliver upside in 2024.

The Quality Lowdown: CMC Challenges Include Pfizer Unit's Quest For Injectable Acetaminophen

Pfizer’s InnoPharma unit finally overcame US FDA’s concerns about injectable acetaminophen GMPs and leachables. Meanwhile, Azurity resolved zonisamide manufacturing issues, Amphastar overcame doubts about naloxone’s nasal spray device, Incyte reused Zynyz CMC data, Cidara showed Rezzayo vials had enough powder, Pharming showed equivalence between Joenja tablets and capsules, and Orphalan avoided half-tablet stability testing of its functionally scored Cuvrior tablets.

Keeping Track: Pharming’s Joenja, Cidara’s Rezzayo And Incyte’s Zynyz Headline US FDA Approval Bonanza

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

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC148098

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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