HBW Insight 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


Terra Biological Pivots To Pre-IND Trials After FDA Spoils Medical Food Labeling

This article was originally published in The Rose Sheet

Executive Summary

FDA warning letter "was a complete surprise to us, especially as we had been advising FDA of our marketing of the CRONaxal product, in writing, for approximately three years as part of our 'orphan drug designation' for glial tumors requirement," says Terra Biological CEO Alan Cook. The firm received an orphan drug designation for oxaloacetate as a treatment for gliomas in 2012.

You may also be interested in...

Microbiome Therapy Firm’s COVID-19 Medical Food Research Landed On US FDA’s Drug Study Menu

Medical food is “for the specific dietary management of a disease or condition for which distinctive nutritional requirements … are established by medical evaluation,” but no distinctive nutritional requirements are established for COVID-19, FDA says. Kaleido says in SEC filing that it “intends to continue with its plans to submit an IND for KB109 in support of future clinical research.”

Requiring Infant Formula, Medical Food Shortage Updates Included In US FDA Budget Request

FDA’s justification report published with Biden administration’s FY2022 federal budget request includes $1.194bn for agency’s food programs, which include its oversight of supplement industry, up from $1.11bn in FY2021 appropriation.

Nestle Acquires IM HealthScience, Expands Medical Food Lineup In Latest US Consumer Move

Nestle Health Science acquires IM HealthScience, marketer of medical foods IBgard and FDgard as well as prebiotic and sleep aid supplements. The deal is second recent US consumer health addition for the firm after it said 2020 would be “‘more vigorous” year for acquisitions despite the COVID-19 pandemic.

Related Content


Latest News



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