Friday, 19 Oct 2018

Biologic/Novel Rx

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29 May 2018 Social RT @LCalabreseDO: Interesting study by a careful group of Irish investigators on new biologic approach to GCA- needs f/u!! Ustekinumab: N…
29 May 2018 Social RT @ARD_BMJ: Good overview in @NEJM of the reality of #biosimilars- highly relevant to the current rheumatology landscape https://t.co/BjUb…
24 May 2018 Social Sandoz announces the approval of its infliximab biosimilarZessly (infliximab) by the European Commission. It is approved for use in RA, , adult & pediatric Crohn’s, adult & pediatric ulcerative colitis, AS, PsA and plaque psoriasis https://t.co/V0PJHbeLSp
18 May 2018 Social Based on the recommendation of the Data Monitoring Committee, Regeneron has halted its phase III trial of fasinumab (anti- Nerve Growth Factor mAb), in OA pts w/ knee, hip or low back pain. https://t.co/ZwyjJbNzjm
15 May 2018 Social FDA today approved Retacrit (epoetin alfa-epbx) as 1st approved biosimilar of Epogen/Procrit for anemia caused by CKD, chemotherapy, or zidovudine in HIV . Retacrit is also approved for use before/after surgery to reduce need for RBC transfusions. https://t.co/hpOTz2uQgr
12 May 2018 Social FDA has approved 9 biosimilars in USA> Zarxio, Inflectra, Erelzi, Amjevita, Renflexis, Cyltezo, Ixifi; Mvasi (Avastin), Ogivri (Herceptin). There are 5 more biosimilars (of either filgrastim or herceptin) in front of FDA w/ upcoming PDUFA dates https://t.co/jeQoGJmygF
09 May 2018 News Tocilizumab Beats Anti-TNFs for Treatment Retention
09 May 2018 Social AbbVie Submits Biologics License Application to FDA for Risankizumab (IL-23 Mab) for Moderate to Severe Plaque Psoriasis https://t.co/4lq3xKc6T1
08 May 2018 Social FDA has approved 9 biosimilars in the USA> Zarxio, Inflectra, Erelzi, Amjevita, Renflexis, Cyltezo, Ixifi; Mvasi (Avastin), Ogivri (Herceptin). There are 5 more biosimilars (of either filgrastim or herceptin) in front of FDA w/ upcoming PDUFA dates https://t.co/jeQoGJmygF
03 May 2018 Social Sandoz biosimilar version of rituximab set back by a complete response letter from the FDA delaying development of their RTX biosimilar; same recent fate as Celltrions RTX biosimilar. https://t.co/EkikDMU1u8
24 Apr 2018 News FDA Arthritis Panel Split on the Efficacy and Safety of Baricitinib in RA
16 Apr 2018 Slide of the day 23 FDA Approved Biologics for Use in Rheumatology
11 Apr 2018 Social Shingrix captured 90% of shingles vaccine market, w/ greater efficacy & CDC endorsement, plus is NOT a live vaccine & could be used with biologics. While cost is the same, it has more nuisance side effect & no studies/data in RA, CTD. https://t.co/lycVu8JrQq
09 Apr 2018 Social 2015 US Pharma donated $116 million to Pt advocacy groups. For example Patients for Biologics Safety & Access (who opposes biosimilar substitution and includes Crohn’s & Colitis, Arthritis & Lupus Foundations) accepted $9.1 million from drug companies https://t.co/i3WDjNHu6f
05 Apr 2018 News IL-6 Inhibition Most Effective in Polycyclic Systemic JIA
05 Apr 2018 News Rituximab May Halt ILD in Antisynthetase Syndrome Myositis
29 Mar 2018 Social Large BSRBR study of Serious infections w/ biologics shows SI=5.51 per 100PY for all; tocilizumab was higher vs ETN (HR 1.22; 1.02 to 1.47) & certolizumab lower or equal to ETN. 30-day mortality following SI was 10.4% (95% CI 9.2% to 11.6%). https://t.co/h5BieShHpH
27 Mar 2018 News Anakinra May Attenuate Stroke Outcomes
09 Mar 2018 News FDA Panel Votes to Favor High Dose Xeljanz in Ulcerative Colitis
06 Mar 2018 News Abatacept Efficacy in JIA