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P&T News

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

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
Drug now approved for moderately to severely active ulcerative colitis
Agent decreases the chance of infection due to chemo-induced febrile neutropenia

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

May 22

Drug indicated for use prior to surgery to boost platelet counts
Novel drug is a first-in-class treatment that reduces migraine occurrence
Lucemyra indicated for up to 14 days as part of a long-term treatment plan
Agent can also be used perioperatively in some patients to reduce the need for transfusions
Incidence increased 61% over a 14-year period

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