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P&T News

June 19

However, patent dispute will delay one launch
Some experts still opposed to “right to try” treatments
Approval acquired through tropical disease priority review voucher program
FDA questioning the pharmacokinetics of psoriasis lotion Duobrii
Therapy approved for adults and children with refractory PMBCL or who have relapsed after two or more prior lines of therapy

June 12

Latest failure brings amyloid hypothesis into question
Guidance published on how to best design coverage for treatment of the smallest, most vulnerable victims of the opioid crisis
Agency plans to respond after receipt of letter of concern
Continuous nerve stimulation helps to alleviate withdrawal symptoms
Polypharmacy, including both prescription and OTC drugs, increase risk

June 5

Drug now approved for moderately to severely active ulcerative colitis
Agent decreases the chance of infection due to chemo-induced febrile neutropenia
But some in industry disagree with the idea
Newer data and statistical methods can improve diagnosis and prescribing
A modified form of adoptive cell transfer targets mutations

May 29

Agency cites serious safety risk, lack of benefit
Novel enzyme therapy is for adults with PKU who have uncontrolled blood phenylalanine concentrations with current treatment
Clinical trial of NIH-developed vaccine will evaluate effectiveness of the new agent
Phase 3 results showed significantly longer survival compared to chemotherapy alone

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