Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

SGLT2 Inhibitors' Warning On Ketoacidosis Recommends Drug Holidays

This article was originally published in The Pink Sheet Daily

Executive Summary

Sponsors must also conduct another post-marketing study.

You may also be interested in...



Sotagliflozin: A Potential Test Of Patient-Physician Decision-Making

Sanofi's proposed type 1 diabetes treatment may be beneficial for some patients who want more glycemic control and are willing to perform the necessary monitoring, but how would the US FDA define that population in the label?

Sanofi's Oral Type 1 Diabetes Drug Approval May Hinge On Ketoacidosis Management

US FDA also questions composite efficacy endpoint used in one of the phase III trials as sotagliflozin reaches advisory committee in attempt to become first approved oral type 1 diabetes treatment. Sanofi says that type 1 diabetes patients already manage DKA risk because it is inherent to their condition and patients did not seem bothered by the instructions to handle DKA.

Product Liability Litigation Playbook: Pros And Cons For Pharma

Drug makers are winning cases by getting expert testimony tossed, but the AndroGel verdict shows how narrow claims can benefit plaintiffs. The Pink Sheet offers a look at drugs in multidistrict litigation from Abilify to Zoloft.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC143367

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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