Scrip 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

Motif Bio Poised For Filings As Iclaprim Succeeds Again In Phase III

Executive Summary

Positive data from a second Phase III trial sets up Motif Bio for an NDA filing by the end of the year for novel antibiotic iclaprim – but success for the product has been a long time coming.

You may also be interested in...



New Trial With Longer Liver Elevation Needed For Iclaprim, US FDA Tells Motif Bio

Longer follow-up is part of regulatory path forward, the struggling antibiotics firm says after meeting with US FDA to discuss complete response letter.

Money Too Tight To Mention At Motif After Iclaprim 'No' From FDA

Hit with a complete response letter from the US FDA for its antibiotic to treat ABSSSI, Motif needs to raise funds and fast to stay afloat and prepare a meeting package to discuss the next steps for iclaprim with the agency.

Keeping Track: Rebuff Of Iclaprim Creates Early Pileup Of CRLs For Novel Drugs

The latest drug development news and highlights from our US FDA Performance Tracker.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC099607

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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