Drug Pipeline

FDA recently approved the first over-the-counter test for HIV, providing a confidential in-home testing option for the virus that causes AIDS, with results in as little as 20 minutes.

FDA is alerting healthcare professionals to the possibility that a 32-mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) could lead to QT interval prolongation, putting patients at risk for a potentially fatal heart rhythm known as Torsades de Pointes.

Brightly colored prescription warning labels applied by pharmacies fail to adequately capture the attention of older patients, suggesting that current labeling standards should be reconsidered to make them more effective, according to a study published online June 14 in PLoS ONE.

A panel at AMCP's annual meeting discussed the need to improve MS medication adherence.

Recent FDA Approvals (through June 2012) related to (GlaxoSmithKline, XenoPort, Roche)

New molecular entity: FDA approved the soral phosphodiesterase-5 (PDE-5) inhibitor, avanafil (Stendra, Vivus) for the treatment of ED.

Forecasts from AMCP's annual meeting indicate a full pipeline for specialty medications.

Recent FDA action (through June 2012) related to, Darunavir, Prezista, Janssen Therapeutics, Ridaforolimus, Merck, Tafamidis meglumine, Pfizer, mechlorethamine, Ceptaris Therapeutics, AVP-923, Avanir Pharmaceuticals, NKTR-181, Nektar Therapeutics, EDI200, Edimer Pharmaceuticals, Galeterone, TOK-001, Tokai Pharmaceuticals, Butoconazole nitrate 2% vaginal cream, Gynazole-1, Perrigo

New molecular entity: FDA approved tafluprost 0.0015% (Zioptan, Merck) ophthalmic solution to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

A new study of patients with moderate-to-severe Alzheimer's disease found that extended treatment with donepezil could improve cognition and function for even severe patients; however, experts caution that the benefits of the drug were modest.

Approximately half of drug labels don't have information on the medication's safety and proper dosing in children, according to a study from FDA researchers.

A review of drug therapies and research presented at the 2012 Annual Meeting of the American Psychiatric Association

While scientists and biomedical researchers at the recent meeting of the American Society of Clinical Oncology (ASCO) applauded encouraging data on dozens of breakthrough cancer therapies, analysts pondered strategies for convincing payers to cover the new life-saving drugs.

The rising cost of specialty drugs, challenges with medication adherence, and the utilizations of mail order are among the top trends impacting employers and other health plan sponsors, according to a recent report about prescription benefit management trends.

FDA issued a statement reminding healthcare professionals about the need to adjust the dosage of the antibacterial drug cefepime (Maxipime, Elan) in patients with renal impairment.

A study indicates that new drugs offer real promise to hepatitis C patients.

The current compendia landscape, through constantly in flux, impacts everything from payer approval of off-label use to manufacturer patient access initiatives. Drug compendia, defined as summaries of drug information, affects coverage and reimbursement decisions for pharmaceuticals products, and as a result, it's important for pharmaceitucal manufacturers and healthcare providers to understand the role and impact of compendia off-label uses.

Humana Inc. and Novo Nordisk have announced a 1-year partnership aimed at identifying ways to improve the care and treatment of patients with diabetes.

New molecular entity: FDA approved lucinactant (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk of RDS.

FDA recently issued a warning about an increased risk of developing new cancers for patients taking lenalidomide (Revlimid, Celgene) for the treatment of multiple myeloma.

Recent FDA Approvals (through May 2012) related to (Meda, Novo Nordisk, Janssen, Vivus, Clinigen, GlaxoSmithKline, Stride Arcolab)

Recent FDA action (through May 2012) related to, Loxapine, Adasuve, Alexza Pharmaceuticals, Denosumab, Xgeva, Amgen, Furiex, Takeda, Nesina, alogliptin, fixed-dose combination alogliptin and pioglitazone, Liovel, Emtricitabine and tenofovir disoproxil fumarate, Truvada, Gilead Sciences, Lorcaserin, Arena Pharmaceuticals, Eisai, Tofacitinib, Pfizer, Tafamidis, ACH-3102, Achillion, CK-2017357, Cytokinetics, Taliglucerase alfa, Elelyso, Pfizer, Carisbamate, SK Biopharmaceuticals, Vancomycin hydrochloride, Vancocin, Akorn, Watson

On May 15, 2012, FDA announced completion of their safety review of fingolimod (Gilenya, Novartis).

As FDA considers a new paradigm that would expand the definition of nonprescription drugs, healthcare experts say the proposed paradigm could have its benefits and challenges for the healthcare industry.

A look at liposomal bupivacaine, a local anesthetic providing pain relief post-surgery

New molecular entity: FDA approved the synthetic, pegylated erythropoiesis-stimulating agent (ESA) peginesatide (Omontys, Affymax) for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

The drive for personalized medicine and greater patient involvement in treatment decisions demands more informative data on the effects and risks associated with drugs and medical products.

Chronic kidney disease (CKD) remains a significant cause of morbidity and mortality. Here's a review of treatment options and guidelines to delay disease progression.

The use of atypical antipsychotics in patients with major depressive disorder who have not responded to antidepressant therapy substantially increased clinical response rates at 6 weeks; however the drugs are also much more costly, according to the results of an analysis published in the May issue of The Annals of Pharmacotherapy.

The multiple sclerosis drug fingolimod (Gilenya, Novartis) is now contraindicated for use in patients with certain pre-existing or recent heart conditions or stroke, or who are taking certain antiarrhythmic medications, according to FDA