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


Surrogate Endpoints Are Dangerous Path For New Antibiotics – JAMA Editorial

Executive Summary

Expedited pathways for acute bacterial infection treatments may increase number of new products at expense of safety and effectiveness, University of Washington doctors warn in JAMA Internal Medicine. Authors criticized trial designs used for Cubist’s Sivextro, Durata’s Dalvance and Theravance’s Vibativ.

You may also be interested in...

Tedizolid, Dalbavancin Still Face Questions On ABSSSI Lesion Measurement

Both antibiotics gain a strong positive recommendation from FDA advisory committee, but questions about how skin lesions were measured before and during treatment persist as experience with new endpoint increases.

FDA Panel Breathes New Life Into Telavancin For Nosocomial Pneumonia

The Anti-Infective Drugs Advisory Committee votes 13-2 in favor of a limited indication for Theravance’s antibiotic, particularly for use in treating methicillin-resistant infections. The endorsement comes after a nearly four-year regulatory battle over the NDA.

Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate

Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.


Related Companies




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