Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Dyax Receives “Complete Response” For HAE Drug; REMS Will Be Required

Executive Summary

Dyax is joining a growing group of companies that have seen their approvals delayed, via a "complete response" letter, to work out a Risk Evaluation and Mitigation Strategy. The Cambridge, Mass. biotech got such a letter March 26 for ecallantide, its drug to treat acute attacks of hereditary angioedema
Advertisement

Related Content

Dyax Kalbitor Is Third To Market For HAE, But First For All Acute Attacks
Dyax Kalbitor Is Third To Market For HAE, But First For All Acute Attacks
Berinert Claims Another Part Of The HAE Orphan Market, But May Leave Room
Berinert Claims Another Part Of The HAE Orphan Market, But May Leave Room
Dyax Readies HAE Therapy Kalbitor For Launch; Awareness Precedes Approval
Dyax Readies HAE Therapy Kalbitor For Launch; Awareness Precedes Approval
ViroPharma Gets Good News And Bad News On Cinryze From FDA
Panel’s Split Decision On Dyax HAE Drug Belies Consensus On Clinical Data
Cinryze Prophylaxis Approval Leaves Window For HAE Treatment Contenders

Topics

Advertisement
UsernamePublicRestriction

Register

PS050876

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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