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

Chiron lowers Fluvirin production estimate

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Chiron will produce 18 mil. to 20 mil. doses of its influenza vaccine Fluvirin for the 2005-06 flu season, the company says June 15. The firm previously projected its production level would be 25 mil. to 30 mil. doses (1Pharmaceutical Approvals Monthly June 2005, In Brief). Chiron expects FDA to inspect its manufacturing facility this month to determine whether deficiencies noted in a December 2004 warning letter have been resolved. GlaxoSmithKline plans to provide 10 mil. doses of its flu vaccine Fluarix for the 2005-06 season; the firm submitted the Fluarix BLA May 25...

You may also be interested in...



GSK Fluarix submission

GlaxoSmithKline anticipates an expedited review for its influenza vaccine Fluarix; the company submitted a BLA May 25. GSK has begun a manufacturing ramp-up aimed at providing 10 mil. doses of the vaccine for the 2005-06 flu season. Competitor Chiron, whose Fluvirin was removed from the market last season due to manufacturing issues, expects to begin shipping 25 mil. to 30 mil. doses of its product in the third quarter; the firm said FDA is slated to inspect its manufacturing facility in mid-June to late July...

FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility

The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.

Sanofi Prepares Pulmonologists As Dupixent Nears COPD Finishing Line

The French drugmaker has identified education as a key challenge ahead of its June action date for the huge-selling IL4/IL-13 inhibitor in the lung condition. An approval would make it the first biologic for the disease.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS002953

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