Monday, 16 Sep 2019

Biologic/Novel Rx

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28 Jun 2019 Social FDA has announced that on July 25th it will hold an Arthritis Advisory Committee Meeting to discuss Boehringer Ingelheims application for Nintedanib use in systemic sclerosis-associated interstitial lung disease (SSc-ILD)
24 Jun 2019 Social "Therapeutic Update: Biosimilars in Rheumatology" video series features nine experts talking about biosimilars, sponsored by Sandoz, Inc. Visit RheumNow to watch: #sponsored #biosimilars
21 Jun 2019 Social RT @LCalabreseDO: Give me your take for my next ED in @HealioRheum on DTC-Direct to-consumer adverstising of Drugs/Biologics (as seen on na…
21 Jun 2019 Social Hear nine experts talk about biosimilars in “Therapeutic Update: Biosimilars in Rheumatology”, a video series brought to viewers by Sandoz. Now available on RheumNow. #sponsored #biosimilars
20 Jun 2019 News No Difference Among Biologics in Arthroplasty Infectious Risk
18 Jun 2019 News Is Methotrexate Necessary with Tofacitinib?
17 Jun 2019 Social Safety and Immunogenicity is one of nine educational videos available in the "Therapeutic Update: Biosimilars in Rheumatology" video series, sponsored by Sandoz, Inc. and now available on RheumNow. #sponsored #biosimilars
29 May 2019 Social FDA has approved the worlds most expensive drug - $2.1 million - Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy for spinal muscular atrophy (SMA) that affects 1 in 11,000 newborns
28 May 2019 News Upadacitinib Monotherapy in MTX-IR Rheumatoid Arthritis
28 May 2019 News Predictors of Serious Infections with Rituximab
21 May 2019 News Nintedanib May Benefit Systemic Sclerosis Related Interstitial Lung Disease
20 May 2019 News EMA Restricts Tofacitinib Dosing
15 May 2019 News FDA Final Guidance on Interchangeability with Biosimilars
09 May 2019 Social Biologic Survival study from Japan- ANSWER study w/ 4466 courses in 2494 pts (2009-17). Efficacy Survival best for ABA, TCZ; worst for IFX & CZP. Toxicity Dropouts most in IFX & ADA, least ABA & CZP. Remission best w/ ETN & ABA, least w/ GLM, IFX.
08 May 2019 Social FDA has approved Ruzurgi (amifampridine) for Lambert-Eaton myasthenic syndrome in children 6-17 years. Drug works by blocking potassium channel efflux in nerve terminals, opening Ca2+ channels & increasing acetylcholine release
29 Apr 2019 Social FDA has approved Samsung-Bioepsis biosimilar version of etanercept - Eticovo (etanercept-ykro), approved in other countries under names Benepali and Brenzys. Approval based on 596 RA pt trial w/ 52 wk ACR20 of 80.8% and 81.5% (Enbrel arm)
24 Apr 2019 News Ustekinumab Effective in Behcet's Disease
23 Apr 2019 Social CORRONA study of 880 RA pts w/ hx of Solid cancer shows many on biologics following Dx. 42% were on biologics/tsDMARDs in the 12 mo before cancer. Post CA 31% were on same Rx, 5% switched biologics &10% started a biologic, the majority starting TNFi (54%).
18 Apr 2019 News Polypharmacy Blunts Responses and Ups the Safety Risks
11 Apr 2019 Social 117 pregnancies exposed to biologics were compared to 585 pregnancies not exposed to biologics; 6% of newborns had ≥1 congenital anomalies. No significant association between biologic exposure and congenital anomalies (HR 1.06; 95%CI 0.46-2.47) was seen.