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

Telavancin’s “Complete Response” Letter Calls For Pregnancy-Focused REMS

This article was originally published in The Pink Sheet Daily

Executive Summary

Theravance is the last of the three sponsors from a marathon advisory committee review of antibiotics for cSSSI to get an action letter; as the only one with a positive vote, it’s the only one that doesn’t need further trials.

You may also be interested in...



Antibiotic Firms Push Ahead With cSSSI Trials, Despite Lack Of FDA Guidance

Antibiotic developers with unpartnered compounds are forging ahead with late-stage trials for complicated skin and skin structure infections, or cSSSI, even though they are still awaiting FDA's formal guidance on drug development in this area

Antibiotic Firms Push Ahead With cSSSI Trials, Despite Lack Of FDA Guidance

Antibiotic developers with unpartnered compounds are forging ahead with late-stage trials for complicated skin and skin structure infections, or cSSSI, even though they are still awaiting FDA's formal guidance on drug development in this area

Approval Delays for J&J/Basilea's Ceftobiprole Shake Partnership

Basilea has become so frustrated with partner Johnson & Johnson's efforts--or lack thereof--to get anti-infective ceftobiprole past the regulators that it has resorted to arbitration. The biotech had few other options, but probably has most to lose.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS069062

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