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

Centocor

Executive Summary

Contracts Bio-Pharm Clinical Services to conduct clinical data management and analyses of the biotech company's new Phase III trial required by FDA for Centoxin (HA-1A) in the treatment of septic shock patients ("The Pink Sheet" June 8, T&G-12). In addition, Centocor has hired the law firm of King & Spalding to audit all of the company's PLA filings "to ensure that procedures and protocols are in place to protect the integrity of clinical trial results and identify any deficiencies or discrepancies which may have existed in the past," Centocor said in a June 26 press release. Centocor's MyoScint PLA, recommended for approval in November, also appears to be stalled at FDA. The company has created a Compliance Oversight Committee reporting to the board of directors, which will "oversee the introduction and monitoring of compliance procedures within Centocor operations and to implement any recommendations resulting from the audits," the firm said.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS021092

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