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Rheumatology Drug Updates: Apremilast, Golimumab, and More

Michele B. Kaufman, PharmD, BCGP  |  Issue: November 2012  |  November 1, 2012


Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a Clinical Pharmacist at New York Downtown Hospital.

References

  1. Apremilast palace program demonstrates robust and consistent statistically significant clinical benefit across three pivotal phase III studies (PALACE-1, 2 & 3) in psoriatic arthritis. Published September 6, 2012. Available at http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=1732178&highlight=. Accessed September 16, 2012.
  2. Kenney B. Janssen submits application to FDA requesting approval of Simponi intravenous formulation for treatment of moderately to severely active rheumatoid arthritis. Published September 18, 2012. Available at www.janssenbiotech.com/assets/PressRelease09182012.pdf. Accessed September 20, 2012.
  3. Dane L. Zalicus to discontinue development of Synavive for RA. Published September 10, 2012. Available at www.firstwordpharma.com/node/1015948. Accessed September 11, 2012.
  4. Regeneron receives complete response letter from FDA for ARCALYST (rilonacept) sBLA for the prevention of gout flares in patients initiating uric acid-lowering therapies. Published July 30, 2012. Available at http://investor.regeneron.com/releasedetail.cfm?ReleaseID=696645. Accessed September 5, 2012.
  5. FDA requests more analysis of Pfizer’s tofacitinib data, regulatory decision could be delayed. Published July 31, 2012. Available at www.firstwordpharma.com/forward/emailref?path=node/1006695. Accessed October 8, 2012.
  6. DeNoon DJ, Chang L. Weight loss pill Qsymia now for sale. Published September 18, 2012. Available at www.webmd.com/diet/news/20120918/weight-loss-pill-qsymia-now-for-sale. Accessed September 19, 2012.
  7. Drugs @ FDA: Qysmia Product Label. Published July 17, 2012. Available at www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s000lbl.pdf. Accessed September 19, 2012.
  8. Qsymia (phentermine and topiramate) extended-release capsules [Category: anorectic and antiepileptic] Risk Evaluation and Mitigation Strategy. Published July 2012. Available at www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM312598.pdf. Accessed September 19, 2012.
  9. FDA approves Horizon’s rheumatoid arthritis drug. Published July 26, 2012. Available at www.reuters.com/article/2012/07/26/us-horizonpharma-fda-arthritisdrug-idUSBRE86P1SV20120726. Accessed September 5, 2012.
  10. Horizon Pharmaceuticals. Published July 26, 2012. Available at www.horizonpharma.com/. Accessed September 5, 2012.
  11. Dane L. Doctors petition FDA to limit opioid drug access, use. Published July 25, 2012. Available at www.firstwordpharma.com/forward/emailref?path=node/1005043. Accessed September 5, 2012.
  12. FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers. Published September 13, 2012. Available at www.fda.gov/Drugs/DrugSafety/ucm318858.htm. Accessed September 19, 2012.
  13. KFDA approves Remsima (infliximab) for autoimmune disease. Published July 23, 2012. Available at www.celltrion.com/EN/05_INVEST/invest03.asp?menu_num=3. Accessed September 19, 2012.

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Filed under:AnalgesicsAxial SpondyloarthritisBiologics/DMARDsConditionsDrug UpdatesPsoriatic Arthritis Tagged with:Ankylosing SpondylitisBiologicsBiosimilarsdrugFDAinfliximabJAK inhibitorsjanus kinaseMethotrexatePipelinePolymyalgia RheumaticaprednisonePsoriatic ArthritisRheumatoid arthritisSafetyTofacitinib

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