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

How Ocular Therapeutix Recovered From US FDA’s Second Dextenza CRL

Executive Summary

A new approach, total dedication and lots of practice made a difference for the Massachusetts start-up after FDA approval was twice deferred over manufacturing quality concerns.

You may also be interested in...



UCB Holds Breath Amid Concerns Of Second FDA Rejection Of Bimzelx

The US Food and Drug Administration has published a report after an inspection of UCB’s Belgian facility where Bimzelx is manufactured and the findings suggest that a long-awaited approval for the psoriasis drug should not be taken for granted.

Finance Watch: Have Investors Reached IPO Fatigue?

Public Company Edition: Codiak, Kiromic, Aligos and Opthea have fallen below their initial public offering values, while Tarsus and Praxis are trading higher. Also, 5AM, MPM and Cormorant took biotech SPACs public and Evotec led recent non-IPO financings with a €250m private placement.

Ocular Analyzes Particulates Root Cause After Whiffing With Steel Blade

Ocular takes another swing at resolving the manufacturing issues that resulted in a complete response letter for its Dextenza.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS140546

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