Antibiotic Development Incentives Could GAIN Support From Pipeline Survey
A survey showing improvement in the pipeline for new antibiotics could further the growing momentum for legislation that would create more development incentives.
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Cubist Sets Sights On European Antibiotics Market With Zurich Move: A Conversation With Patrick Vink
Cubist recently has seen its key antibiotic Cubicin become a blockbuster in the U.S. It is determined to take this success, backed by a flourishing pipeline, to answer Europe's call for products to fight antimicrobial resistance.
PDUFA V Action Heats Up On Hill With House Hearings In February
An Energy and Commerce subcommittee will discuss the FDA and industry agreement on prescription drug user fees with FDA Commissioner Margaret Hamburg Feb. 1. Drug shortages will be part of the deliberations Feb. 7 when CDER Director Janet Woodcock goes before the panel to make the case for user fees on generic drugs and biosimilars.
Drug Shortage Bills Likely Drivers Of PDUFA Add-ons
Rep. Burgess says there appears to be enough bipartisan support for dealing with the shortage problem that it almost certainly will be added to the reauthorizing legislation.