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


Twisted Path Yields 1st Diabetes Drug Approved Since FDA Cardio Guidelines

Executive Summary

After FDA recently issued cardiovascular safety guidelines for diabetes medicines, many large drug makers returned to the clinic to revise their plans. But VeroScience, a small and relatively obscure company, won approval for its Cycloset medication to treat type 2 diabetes on the strength of Phase IIIb trial data that actually exceed FDA's standards

You may also be interested in...

Diabetes Drug Developers Urged To Study Higher Risk Patients By FDA Panel

There is one message that sponsors should take to heart from an FDA advisory committee's first pass at applying new cardiovascular outcomes standards to type 2 diabetes medicines: enroll sicker patients in pivotal trials

FDA’s Diabetes Guidance On CV Risk Will Get First Test With Pending NDAs

FDA's flexibility in applying its new guidance for cardiovascular safety of diabetes drugs will be tested in coming months as it reviews a handful of pending NDAs and enters into discussions about other drugs in late stages of development

FTC Health Claims Guidance ‘Lacks Legal Basis,’ Conflicts With FDA’s Supplement Regulations – CRN

“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”


Latest Headlines
See All



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