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

Approvals & Regulatory Updates, In Brief

Executive Summary

Peramivir gets stockpiled in case of influenza outbreak: BioCryst's I.V. antiviral peramivir is currently undergoing a pre-emergency use authorization review that could mean the I.V. product could be a future option in the event of a severe influenza outbreak, the firm announced May 8. CDC has confirmed sensitivity of the swine flu virus to peramivir; 10 of 13 isolates of the H1N1 virus were tested and all showed susceptibility to peramivir. Based on discussions with the HHS/Biomedical Advanced Research and Development Authority, BioCryst is preparing a portion of its inventory of finished peramivir for addition to the Strategic National Stockpile. The inventory could treat approximately one thousand patients. BioCryst also is in negotiations with the Division of Microbiology and Infectious Diseases and the National Institute of Allergy and Infectious Diseases to conduct a study of peramivir in a pediatric patient population. Clinical development of the product is advancing under a $102.6 million, four-year contract from HHS. Preliminary results of a Phase II study aimed at oseltamivir-resistance with an intramuscular formulation were not statistically significant, but a prior study by Shionogi showed efficacy for the I.V. formulation

You may also be interested in...



Roche Checks Wallet As Important Avastin Trial Flops

After months of anticipation, Roche announced the results of a closely watched clinical trial showing that its Avastin (bevacizumab) medication failed to prevent the recurrence of early-stage colon cancer in patients who underwent surgery

Avastin Clinical Benefit Trumps Anti-Tumor Effect In Glioblastoma, ODAC Says

Demonstration of an anti-tumor effect is not essential for a brain cancer indication if clinical benefit is provided, FDA's Oncology Drugs Advisory Committee indicated March 31 in recommending accelerated approval of Genentech's Avastin to treat relapsed glioblastoma multiforme

Savient Suggests More Restrictive REMS Plan For Pegloticase In BLA Amendment

PDUFA date shifts to July 30; FDA to reschedule advisory committee.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS051030

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