Pink Sheet is part 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

Further Fosrenol studies

Executive Summary

EU reference member state requests additional information on Shire's Fosrenol (lanthanum carbonate), likely extending the review period into the second half of 2003. Shire expects FDA action on Fosrenol shortly...

You may also be interested in...



Shire Fosrenol “approvable”

Shire will submit additional Fosrenol (lanthanum) data and analysis prior to approval of the non-calcium binder to address issues outlined in FDA "approvable" letter, company says March 3. "Shire is initiating a dialogue with the FDA to agree [to] the balance between pre and post approval commitments which will resolve the questions" The European Union also requested additional data (1"The Pink Sheet" March 3, In Brief)...

US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail

Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.

UsernamePublicRestriction

Register

LL043624

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