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

The Regulatory Pendulum Swings In Favor Of Antibiotics, But Will Investments Follow?

This article was originally published in Start Up

Executive Summary

New incentives under the US government’s GAIN Act and FDA’s openness to faster development are helping put antibiotics back on investors’ radar screens, if not yet loosening their checkbooks.

You may also be interested in...



Targeted Antibiotics Could Get Limited Data Approval Option From FDA

Achaogen has designed a registration program with a single Phase III study for its next-generation aminoglycoside, plazomicin, to treat serious infections due to carbapenem-resistant Enterobacteriaceae, in what could be an interesting test for potential modifications to the standard approval pathway.

FDA Worries About Off-Label Use, Stewardship With Limited-Population Approval Pathway

FDA asks groups how it can help ensure prescribing is limited for products approved under proposed new pathway, but several say, other than labeling, it may be out of the agency’s hands.

FDA’s “Limited-Use” Approval Pathway Moves Forward Without Congressional Approval

The agency seeks input on which diseases, beyond drug-resistant infections, could benefit from rapid approval of therapies for subpopulations of patients; public hearing in February will ask how labeling should best express the limited indications.

Related Content

Topics

Related Companies

Related Deals

Latest Headlines
See All
UsernamePublicRestriction

Register

SC092429

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