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

EMPA-REG Data Will Boost Jardiance's Role In Combination Therapy, Lilly Says

Executive Summary

Large outcomes trial showing a cardiovascular benefit with empagliflozin could shift the treatment landscape to earlier use of the SGLT2 inhibitor in combination therapy rather than replacing treatment with metformin and other agents, Lilly Diabetes President Conterno predicts.

You may also be interested in...



FDA Warning On SGLT-2 Drugs Raises Specter Of Labeling Change

FAERS reports identify cases of diabetic ketoacidosis, ordinarily rare in type 2 diabetes, which were not associated with high blood sugar levels.

Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials

Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.

Two Years In US Accelerated Approval Withdrawals

Twenty accelerated approval indications have been voluntarily withdrawn by sponsors since December 2020, most coming as a result of the FDA cancer office’s push to rid labeling of ‘dangling’ and ‘delinquent’ indications that lack confirmation of clinical benefit.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS057156

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