Drug Pipeline

The recent approval by FDA of an adult cancer therapy is 1 example of how children’s cancer research benefits patients of all ages.

FDA Commissioner Margaret A. Hamburg, MD, recently released a blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans.

Tracking and preparing for the approval of generic products is 1 of the key components of proactive formulary management. Unfortunately, forecasting FDA approval of the first generic inhaled corticosteroid products is difficult.

According to a recent study, $5.8 billion was spent in 1 year on the unnecessary prescription of brand-name statins.

Middle-aged women with RLS may be at higher risk of developing high blood pressure, according to a study published online October 10 in Hypertension: Journal of the American Heart Association.

Drug companies sponsoring human trials of possible new medications have ethical responsibilities to study participants and to science to disclose the results of their clinical research, even when product development is no longer being pursued.

New molecular entity: Ticagrelor tablets were FDA approved to reduce rate of thrombotic cardiovascular events in patients with ACS.

Dapagliflozin is a sodium glucose co-transporter inhibitor under review for FDA approval for the treatment of type 2 diabetes mellitus. Despite the availability of many antidiabetic agents in the United States, type 2 diabetes remains inadequately controlled in many patients.

FDA is requiring the zoledronic acid (Reclast, Novartis) prescribing information to now include a warning not to use the drug in those with renal dysfunction.

It's flu season again, which always focuses public attention on the reliablity and availability of the nation's vaccine supply.

In sexually active partners, early treatment with antiretroviral therapy compared to delayed treatment decreased the risk of genetically linked HIV-1 transmission to the uninfected partner.

Axitinib, an investigational selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 significantly extended progression-free survival compared with sorafenib in patients with previously treated metastatic renal cell carcinoma.

Diarrhea-associated healthcare utilization and treatment costs for US children <5 years of age

Recent FDA action (through September 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001, cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127

New molecular entity: Rivaroxaban was FDA approved for prevention of deep vein thrombosis.

In a safety communication released September 7, 2011, FDA announced it is requiring the prescribing information for all tumor necrosis factor-alpha blockers to include a black-boxed warning regarding an increased risk of infection from 2 bacterial pathogens, Legionella and Listeria.

National Heart, Lung, and Blood Institute-sponsored cardiovascular trials often enroll a "substantial" proportion of international participants.

Biologic agents have no effect on the rate of major adverse cardiovascular events in patients suffering from chronic plaque psoriasis.

The importance of ensuring that pharmacist-provided clinical services are represented in the electronic health record has come to the forefront with the Pharmacy e-Health Information Technology Collaborative.

In patients with psoriasis or rheumatoid arthritis, the use of tumor necrosis factor inhibitors or hydroxychloroquine, but not methotrexate, was associated with a decrease in the incidence of diabetes compared to other disease-modifying antirheumatic drugs.

Recent FDA Approvals (through September 2011) related to Remicade, Prolia, haloperidol injection, Soliris

Osteoporosis is a widespread condition with significant morbidity and mortality affecting millions of people in the United States and worldwide. Incidence is expected to increase as the population ages.

The first step toward a national electronic system that will transform FDA?s ability to track the safety of drugs, biologics, and medical devices is up and running, according to a recent press release announcing the Mini-Sentinel Pilot project.

Patients discharged from the hospital are at an elevated risk of not continuing their long-term medications for chronic diseases, and ICU admission appears to further increase this risk, according a recent study published August 24 in the Journal of the American Medical Association.

FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart.

Linaclotide, an investigational drug for the relief of chronic constipation, appears to be effective and safe, according to the results of two phase 3 trials published in the August issue of the New England Journal of Medicine.

Colchicine, a widely used drug for the prevention and treatment of gout flares, interacts dangerously with many commonly prescribed pharmaceuticals, such as antibiotics, anti-hypertensive drugs, anti-fungals, immunosuppresants and protease inhibitors, according to a study published in the August issue of Arthritis & Rheumatism. However, most patients can take colchicines safely with these medications as long as the dose is adjusted, the study indicated.

FDA has approved emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera, Gilead Sciences), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.

How much do employers know regarding biologics and specialty pharmacy?

FDA has approved the first antivenom treatment specifically for a scorpion sting by the Centruroides scorpions in the United States. The new biologic treatment?called Anascorp?was designated an orphan drug and given priority review because adequate treatment did not exist in the United States, according to a consumer update and corresponding news release issued by the agency.