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

FDA Likely To Allow Outcomes Studies Post-Approval For Fat Emulsion Drugs

Executive Summary

Agency will probably clear products based on non-inferiority studies with nutrition endpoints, but ultimately wants clinical outcomes trials.

You may also be interested in...



Baxter’s Clinolipid Could Offer Safety Advantages While Mitigating Shortage

Though it doesn’t have a formal labeling claim, olive-oil based parenteral nutrition drug provides marketing advantages compared to soybean fat emulsions drugs, while helping to ease shortage.

Hospira Halts Shipment Of Two Drugs After FDA Warning Letter

Voluntary hold on Propofol, Liposyn will negatively impact 2010 sales, though acquisition of Orchid will help make up the difference.

Regeneron President Booed At Conference Over Comments Urging Focus On Innovation Before Access

Regeneron President George Yancopoulos got in a screaming match at Milken conference, arguing paying for cures is a secondary problem that should be tackled once such products are developed. He also talked about how he believes tech companies are helping to create some of America’s health crises.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS055720

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