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P&T News

October 31

Calquence demonstrated favorable overall response rate in initial studies

October 30

Inconsistent evidence prompts agency to re-evaluate link between soy products and cardiovascular health
Phase 3 study demonstrated 10-mg dose reduced risk of recurrent VTE by up to 74%
MM-121 is a fully human monoclonal antibody designed to block tumor survival signals
They also had significantly fewer new brain lesions versus those on interferon beta-1a
Subgroup analysis demonstrates improvement in patients who experienced at least one attack per week while on placebo

October 26

Vaccination now recommended starting at age 50
Duchenne muscular dystrophy drug fared poorly in trials
Rate of high total cholesterol falls from 18.3% to 12.4%
Medication helps prevent nausea and vomiting after chemotherapy
BioMarin Pharmaceutical is developing valoctocogene roxaparvovec

October 24

Agency not told of test alterations and customer complaints
Drug approved last April for treatment of adults with tardive dyskinesia
Designation aims to expedite development in combination with lenalidomide

October 23

Socioeconomic status doesn’t explain all the discrepancies
Regulatory rules are the key to achieving future savings, RAND says
Shingrix targets painful problem that strikes one in three
AstraZeneca introduces improved autoinjector

October 20

Efficacy shown in GO-VIBRANT and GO-ALIVE studies

October 19

Treatment targets relapsed or refractory large B-cell lymphoma