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.
- FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.
- ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.
- CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.
- Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.
- Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.
- Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.
- Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.
- INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.
- Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.
- Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.
- Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.
- Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.
- Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.
- US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.
- Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.