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

UsernamePublicRestriction
UsernamePublicRestriction

With GAIN In Place, Antibiotic Improvements Depend On FDA Implementation

Executive Summary

FDA and industry are turning their attention to implementation of the Generating Antibiotic Incentives Now provisions of PDUFA V, which include an additional five years of marketing exclusivity for certain products and new guidance aimed at streamlining the drug development process.

You may also be interested in...



Antimicrobial Drug/Test Joint Development Needs Better Incentives

Stakeholders still need to develop solutions that will allow faster development of susceptibility testing devices, and in turn facilitate prescribing of new antimicrobial drugs.

Antibiotic Incentives Helped Spero Get Where It Is Today

The firm is developing a novel class of antibacterials that could enable shelved agents for Gram-positive infections to reach and kill Gram-negative bacteria.

Cubist’s Zerbaxa Approval Marks Firm’s Second Novel Antibiotic In 2014

With only two weeks left in 2014, Cubist grabs another FDA approval for an antibiotic, this time to treat Gram-negative infections.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS054669

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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