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P&T News

July 24

Renflexis also costs 20% less than a biosimilar already on the market
Government, industry, and advocacy groups collaborate on Expanded Access Navigator
Designed for NICUs, system negates moving babies within the hospital
Seeking to limit spread of infections, FDA clears improved device and manual
Patients will be able to avoid hour-long infusions at health care facilities

July 20

New single-tablet regiment indicated for genotypes 1 to 6
The problem could undercut years of progress
A couple of other steps may be waiting in the wings
Physical activity, blood pressure control, cognitive training all help
Still, some facilities are dipping a toe into the water

July 18

NKTR-181 is a first-in-class investigational opioid to treat chronic pain
Neither replacing nor repealing the act have the votes they need
Paratek is planning to submit an application in the first quarter of 2018
Adjuvant therapy for HER2-positive tumors indicated after Herceptin treatment
The move is an effort to spread the sharing of risk

July 17

The agency’s current experts will play a role in recruiting new staff
First and only biologic approved that selectively blocks interleukin-23.
National Academies report urges a much more systematic approach
Surgery did not improve mortality outcomes in patients with localized disease
Complete response letter will lead to resubmission of application