News

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.

Large health plans across the country are diving into accountable care with some degree of success.

Four-tier formularies have emerged as one method to control the rising costs associated with specialty pharmaceuticals.

The National Association of Boards of Pharmacy has developed a platform for sharing prescription monitoring programs

Insurers must invent new healthcare solutions to be competitive in the market emerging under the Patient Protection and Affordable Care Act, according to a new report.

Edith Rosato will take over for long-time CEO Judith Cahill, who announced retirement plans earlier this year.

Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution during pregnancy, as exposure may increase the risk of spontaneous abortion, reported a study published online September 6 in the Canadian Medical Association Journal.

An interaction between warfarin and acetaminophen may result in significant elevations of international normalized ratio (INR), putting patients at increased risk for hemorrhagic complications.

FDA has notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from 2 bacterial pathogens, Legionella and Listeria.

FDA has issued a complete response letter for a golimumab (Simponi, Janssen Biotech) supplemental Biologics License Application seeking an expanded label in the treatment of active psoriatic arthritis.

An FDA advisory panel voted 9-2 (with 1 abstention) to recommend approval for rivaroxaban (Xarelto, Johnson & Johnson and Bayer AG), an oral, once-daily anticoagulant as a treatment to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

FDA has approved an antipsychotic medication, haloperidol injection, USP (Sagent Pharmaceuticals), indicated for use in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette's disorder.

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 issued a Safety Announcement warning that serious allergic reactions have been reported with the use of the antipsychotic medication asenapine maleate (Saphris).

Drugs such as Taxol, Cytarabine, Daunorubicin, Doxil, and Leucovorin are in short supply, delaying patients with various forms of cancer from getting the treatments they need or forcing them to seek alternative, possibly less-effective treatments, FDA announced recently.

FDA is alerting healthcare professionals that repackaged intravitreal injections of Roche Holdings' Avastin (bevacizumab) have caused a cluster of serious eye infections in the Miami, Fla., area.

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.

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.