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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Horizon Pharmaceuticals. Published July 26, 2012. Available at www.horizonpharma.com/. Accessed September 5, 2012.
- 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.
- 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.
- 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.