Drug Pipeline

Among the long-awaited provisions in PPACA are the additions to the Public Health Service Act that allow for the introduction of biosimilar medications to the marketplace.

Two Drug Safety Communications providing updated warnings regarding potentially serious interactions when methylene blue or linezolid are co-administered with certain serotonergic psychiatric medications were released by FDA on October 20, 2011.

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.