Articles By Jack Cush, MD
DSB Reports & Updates – August 2017
This Drug Safety Bulletin address FDA delay of baricitinib, etanercept effective at room temperature, Consumer Reports features on drug safety, no association between Alzheimer's and PPIs, AHRQ review of opioid drug safety, FDA safety abeling changes, drug shortages and more.
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Canakinumab Patients have Lower Risk of Lung Cancer
The CANTOS trial has shown that interleukin 1β inhibition by Canakinumab (CAN) resulted not only in a reduction of cardiovascular deaths but also significantly decreased the incidence and death from lung cancer.
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Turnabout for Baricitinib
Eli Lilly and Company and Incyte Corporation announced today that, after discussions with the U.S. Food and Drug Administration in late August 2017, Lilly will resubmit a revised New Drug Application for baricitinib before the end of January 2018. The resubmission package will include new safety and efficacy data.
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Patient Recordings of Visits May be Legal
The current issue of JAMA reviews the rising practice of patient recording of medical visits and their legality.
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Shingles Vaccine Studies in A&R
The current issue of Arthritis & Rheumatology features an editorial and two novel articles on the herpes zoster vaccine.
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Canakinumab Reduces CV Outcomes in High Risk Patients
The results of a randomized, double-blind trial have shown that canakinumab (CAN), an interleukin-1β inhibitor, given as 150 mg every 3 months, resulted in a significantly lower rate of recurrent cardiovascular events (in high-risk CV patients), independent of lipid-level lowering. The results of the CANTOS studywere simultaneously published in NEJM, Lancet and were presented at the European Society of Cardiology meeting in Barcelona.
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Another Adalimumab Biosimilar Approved
On Friday August 25th, the FDA approved another adalimumab biosimilar: Cyltezo (generic name: adalimumab-adbm).
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Adalimumab Biosimilars Adding Up
Reuters reports that yet another adalimumab biosimilar has been approved by European Union regulators. The new drug is named Imraldi, and is manufactured by Samsung Bioepis, a company who has several biosimilars approved or in development for worldwide use.
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The RheumNow Week in Review – 25 August 2017
The RheumNow Week in Review discusses the past week's news, journal articles and highlights from RheumNow.com. This week's report includes new data on IL-1 and pregnancy, contraceptives and the risk of RA, Calprotectin the biomarker, T2T failing, and the loss of a giant in rheumatology.
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Dr. H. Ralph Schumacher (1933-2017)
Dr. H. Ralph Schumacher passed away from ALS in July 30, 2017. The current issues of The Rheumatologist and the Journal of Clinical Rheumatology have beautiful tributes written by Dr. Simon Helfgott and past ACR president Dr.
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