News

Denosumab (Xgeva, Amgen) significantly increased bone metastasis-free survival for more than 4 months in men with castrate-resistant metastatic prostate cancer that had not yet spread to bone, according to results of a landmark study of Xgeva, presented at a late-breaking plenary session at the American Urological Association?s 2011 annual meeting in Washington, DC.

FDA has approved everolimus (Afinitor, Novartis) tablets to treat patients with progressive neuroendocrine tumors of pancreatic origin that cannot be removed by surgery or that have spread to other parts of the body.

The National Lipid Association is kicking off a public health campaign about familial hypercholesterolemia on May 18. The start of the campaign, ?FH: It?s Relative?Know Your Family Cholesterol History,? coincides with NLA?s Annual Scientific Sessions in New York City.

The lipid-lowering efficacy and tolerability of bile acid sequestrants suggest that these agents have potential in pediatric patients with familial hypercholesterolemia, according to a recent literature review from the University of Chicago Pritzker School of Medicine.

The American Heart Association recently released its updated cardiovascular disease prevention guidelines for women. The guidelines emphasize practical medical advice that works in the "real world" rather than on findings primarily observed in clinical research.

Two of the most commonly used treatments for neovascular AMD, ranibizumab (Lucentis, Genentech), approved in 2006 by FDA, and the other commonly used ?off-label,? bevacizumab (Avastin, Genentech), resulted in similar improvements in visual acuity, according to a new randomized controlled trial published in NEJM.

FDA recently issued warning letters to companies that manufacture and market over-the-counter products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylocococcus aureus.

FDA has approved everolimus (Afinitor, Novartis) tablets to treat patients with progressive neuroendocrine tumors of pancreatic origin that cannot be removed by surgery or that have spread to other parts of the body (metastatic).

The Academy of Managed Care Pharmacy recently installed 4 new members to its board of directors. The new board members were sworn in April 29 at AMCP?s 23rd Annual Meeting & Showcase in Minneapolis.

In patients with chronic low back pain with comorbidities such as hypertension, diabetes, and cardiovascular disease, extended-release oxymorphone (Opana ER, Endo Pharmaceuticals) may be a safe and effective alternative, according to a study presented at the annual meeting of the American Academy of Pain Medicine, National Harbor, Md.

No new or unexpected safety issues occurred during long-term treatment with a fixed-dose combination of naproxen and esomeprazole magnesium (Vimovo) in patients at risk of NSAID-associated upper gastrointestinal ulcers, according to data presented at the annual meeting of the American Academy of Pain Medicine, National Harbor, Md.

FDA has approved abiraterone acetate (Zytiga, Centocor Ortho Biotech), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

Hemoglobin A1c levels below 6% are associated with a small but significant increased risk of mortality in elderly patients, according to a retrospective cohort study published online in Diabetes Care.

FDA approved the use of meningococcal (A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra, Sanofi Pasteur) in children aged as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135.

A daily dose of opioids for nonmalignant pain is strongly associated with opioid-related mortality, and doses of 200 mg or more of morphine or equivalent are associated with a particularly high risk, according to a recent study published in the April issue of Archives of Internal Medicine.

FDA approved linagliptin (Tradjenta, Boehringer Ingelheim and Eli Lilly) tablets, used with diet and exercise, to improve blood glucose control in adults with type 2 diabetes.

Agents in late-stage development of major depressive disorder and generalized anxiety disorder.

The effectiveness and safety of proton pump inhibitors for pediatric gastroesophageal reflux disease are far from proven, according to a new systematic review.

Systemic lupus erythematosus is a multi-organ, autoimmune inflammatory disease. The annual incidence of SLE in the United States ranges from 2.0 to 7.6 cases per 100,000 persons per year. This review examines the clinical course of SLE, various treatment options, and the treatment of specific manifestations of the disease such as lupus nephritis.

The FDA has released a safety communication alerting healthcare providers to a new risk evaluation and mitigation strategy for ipilimumab.

Recent FDA Approvals (through April 2011) related to Actemra, Menactra, Zytiga, Rituxan, Invega, Vandetanib, Viramune XR, Horizant

Drug devleopment pipelines have shrunk; fewer new products are being approved for market; and pharma companies are scaling back R&D as patent expirations on blockbuster drugs reduce industry revenues.

Recent FDA action (through April 2011) related to Liprotamase, Aricept Patch, Telaprevir, Restylane Injectable Gel, VEGF Trap-Eye, Cenderitide, PV-10, INNO-206

A new selective estrogen receptor modulator, bazedoxifene acetate, is currently under development in an effort to maximize potential benefits on bone, lipids and breast tissue while minimizing endometrial hyperplasia and other adverse effects.

The American College of Rheumatology has developed new guidelines for starting and monitoring treatments for children with juvenile idiopathic arthritis.

New molecular entity: Roflumilast oral treatment was approved by FDA as treatment to reduce risk of COPD exacerbations.

Alcoholics who are tested for genotype specificity prior to receiving ondansetron may have significantly improved outcomes, according to new research.

Analysis of the hepatitis C virus kinetics during treatment with protease inhibitor telaprevir shows a rapid decline, according to a new study.

Generic drug approved by FDA (through May 2011): Latanoprost

New molecular entity: Azilsartan medoxomil tablets are selective AT1 subtype angiotensin receptor antagonists that were approved by FDA to lower blood pressure.