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

Optimer Pharmaceuticals, Inc.

http://www.optimerpharma.com/

Latest From Optimer Pharmaceuticals, Inc.

Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters

Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab  the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.

US FDA Performance Tracker Complete Response Letters

Pear Bankruptcy Filing Highlights Difficult Challenges Facing Digital Therapeutics

Pear Therapeutics filed for Chapter 11 bankruptcy in April and sold its remaining assets in an auction for about $6m. The demise of one the pioneers in the prescription digital therapeutics industry highlights the challenges PDT developers face getting their products reimbursed.

Digital Health Business Strategies

Lilly Strikes Out With The FDA For Second Time This Year With Mirikizumab CRL

With mirikizumab delayed until Lilly overcomes the FDA’s manufacturing concerns, the company has fallen behind on its goal of five approvals in 2023.

Complete Response Letters Manufacturing

Novo Nordisk Teams With Aspect Biosystems On Diabetes Cell Therapy

Aspect says its bioprinted tissue therapeutics include immune-resistant encapsulation, which Novo Nordisk hopes will offer a safer approach to type 1 diabetes cell therapy.

Business Strategies Deals
See All

Company Information

UsernamePublicRestriction

Register