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- Page 178
Eltrombopag: A TPO receptor agonist for the treatment of chronic idiopathic thrombocytopenic purpura
October 1, 2008
Eltrombopag is a TPO receptor agonist that is currently pending FDA approval for the treatment of ITP. This agent has been granted orphan drug and priority review status. In May 2008, the Oncology Drugs Advisory Committee unanimously agreed that eltrombopag demonstrates a favorable risk:benefit profile for the short-term treatment of chronic ITP.
FDA actions in brief, October 2008 (Cancidas, Aloxi, Vidaza)
October 1, 2008
Recent FDA approvals and indications (through October 2008) related to Cancidas, Aloxi, and Vidaza.
Romiplostim (Nplate): Thrombopoietin mimetic peptibody approved for the treatment of chronic ITP
October 1, 2008
New biologic: Romiplostim (Nplate), a thrombopoietin mimetic peptibody, was approved on August 22, 2008, for the treatment of chronic ITP.
Tetrabenazine (Xenazine): Monoamine depleter approved for the treatment of chorea associated with Huntington's disease
October 1, 2008
New molecular entity: Tetrabenazine (Xenazine), a monoamine depleter, was approved on August 15, 2008, for the treatment of chorea associated with Huntington's disease.
Rational approaches to the treatment of mixed dyslipidemia
October 1, 2008
This article reviews the role of individual therapeutic agents and combination therapies that can be used for the treatment of mixed dyslipidemia.
Comparative effectiveness research legislation likely to raise drug pricing issues
September 1, 2008
The Comparative Effectiveness Research Act of 2008 would establish the Health Care Comparative Effectiveness Research Institute as a private, nonprofit, nongovernmental entity that would contract with government agencies and private research organizations to conduct systematic reviews, observational studies, and randomized controlled clinical trials to obtain evidence regarding the clinical effectiveness of therapies and treatments.
Primary androgen deprivation therapy does not prolong survival in most patients with prostate cancer
September 1, 2008
Primary androgen deprivation therapy (PADT), the second most common treatment for localized prostate cancer following prostatectomy, is no more effective than conservative medical management for prolonging survival in most older patients with prostate cancer.
Labeling updates and warnings through September 2008
September 1, 2008
Labeling updates and warnings through September 2008 for intramuscular naltrexone (Vivitrol) and for simvastatin (Zocor; generic simvastatin), ezetimibe/simvastatin (Vytorin), and niacin extended-release/simvastatin (Simcor) when used concurrently with amiodarone (Cordarone; Pacerone; generic amiodarone)
Rofecoxib, valdecoxib associated with increased risk of stroke
September 1, 2008
A retrospective cohort study published in the journal Stroke demonstrated an increased risk of stroke among users of rofecoxib and valdecoxib but not among users of other nonsteroidal anti-inflammatory drugs (NSAIDs).
Potentially inappropriate medication use in hospitalized older adults: A DUE using the full Beers criteria
September 1, 2008
The purpose of this drug use evaluation was to report potentially inappropriate medication use, as defined by the full Beers criteria.
Alogliptin: A dipeptidyl peptidase-IV inhibitor for the treatment of type 2 diabetes
September 1, 2008
Alogliptin is a highly selective DPP-IV inhibitor under investigation for the treatment of type 2 diabetes. An NDA for alogliptin was submitted in January 2008, and a response from FDA is expected in the fourth quarter of this year.
First-time generic drug approvals, September 2008
September 1, 2008
Generic drugs approved by FDA (through September 2008) including nisoldipine extended-release tablets and divalproex delayed-release tablets
FDA Pipeline preview, September 2008
September 1, 2008
Recent FDA action (through September 2008) related to Immediate-release diclofenac capsules, tocilizumab, sugammadex, topical alprostadil cream, fospropofol, iloperidone, lacosamide, and vascular endothelial growth factor b.
FDA actions in brief, September 2008
September 1, 2008
Recent FDA approvals and indications (through September 2008) related to Diovan HCT, Exforge, Cleviprex, Eovist, Stavzor, Promus Everolimus-Eluting stent, and Xience V Everolimus-Eluting stent
Tenofovir (Viread): Antiviral agent approved for the treatment of chronic hepatitis B in adults
September 1, 2008
New indication: Tenofovir (Viread), an antiviral agent, was approved on August 13, 2008, for the treatment of chronic hepatitis B in adults.
Drug Watch: Agents in late-stage development for the treatment of types 1 and 2 diabetes mellitus (September 2008) (PDF)
September 1, 2008
Drug Watch: Agents in late-stage development for the treatment of types 1 and 2 diabetes mellitus (September 2008)
Formulary Digital Edition September 2008
September 1, 2008
Potentially inappropriate medication use in hospitalized older adults: A DUE using the full Beers criteria; Focus on alogliptin; Drug Watch: Agents in late-stage development for the treatment of types 1 and 2 diabetes mellitus
Formulary Digital Edition August 2008
August 1, 2008
Clinical updates from the 68th Scientific Sessions of the American Diabetes Association; Focus on tocilizumab; Drug Watch: Agents in late-stage development for the treatment of type 2 diabetes mellitus
Information for Authors (revised 8/2008) (PDF)
August 1, 2008
Information for Authors (revised 8/2008) (PDF)
Erythropoiesis-stimulating agents for anemia in older adults
August 1, 2008
Erythropoietin, a humoral factor produced predominantly in the kidney, stimulates red blood cell production in the bone marrow. Erythropoiesis-stimulating agents (ESAs) have been used for years in the treatment of anemia, with extensive experience and benefits in anemia of chronic kidney disease. Recent data have suggested adverse consequences with use of ESAs, perhaps relating to inappropriate use, and prompting release of guidelines to ensure safe use and maximize benefit. When prescribing ESAs, indications, requirements to monitor laboratory parameters (hemoglobin levels and ferrokinetics), and clinical status need to be stringently followed.
Safety surveillance to transform drug development and oversight
August 1, 2008
FDA has launched the Sentinel Initiative to expand and improve medical product risk detection and evaluation. Instead of relying on passive, voluntary adverse event (AE) reports sent to FDA by physicians and pharmacists, the agency would be able to detect safety signals much more quickly through links to health information databases containing information about millions of patients.
Raltegravir plus optimized background therapy superior to optimized background therapy alone in treatment of resistant HIV
August 1, 2008
Two randomized, double-blind, phase 3 clinical trials demonstrated that raltegravir plus optimized background therapy was more effective than optimized background therapy alone in suppressing resistant HIV-1.
Treatment with SSRIs or venlaxafine associated with increased risk of GI bleeding
August 1, 2008
In a nested, case-control study published in the Archives of General Psychiatry, investigators observed that the use of selective serotonin-reuptake inhibitors (SSRIs) increased the risk of upper gastrointestinal (GI) tract bleeding; this increased risk was also observed with the serotonin and norepinephrine reuptake inhibitor (SNRI) venlafaxine. This risk may be increased when the agents are used concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDs) and decreased when used concomitantly with acid-suppressing agents.
Methotrexate plus etanercept effective in inducing clinical remission in patients with early moderate-to-severe RA
August 1, 2008
The first phase of a double-blind, randomized, parallel-group, multicenter, outpatient study demonstrated that treatment with the combination of etanercept and methotrexate was more effective in inducing both clinical remission and radiographic nonprogression than methotrexate alone in patients with early moderate-to-severe rheumatoid arthritis (RA).
Addition of aliskiren to losartan provides additional renal protective effects in hypertensive patients with type 2 diabetic nephropathy
August 1, 2008
A recent multinational, randomized, double-blind, placebo-controlled clinical trial demonstrated that administration of aliskiren provides additional renal protection to patients with hypertension, type 2 diabetes mellitus, and nephropathy who are already receiving optimal antihypertensive therapy and renal protective therapy with the angiotensin receptor blocker (ARB) losartan.
Clinical news updates from the 68th Scientific Sessions of the American Diabetes Association
August 1, 2008
Among the new data presented at the 68th Scientific Sessions of the ADA were the results of phase 3 trials of the investigational agents liraglutide, ABT-335, saxagliptin, and alogliptin.
Tocilizumab: A humanized anti-IL-6 receptor monoclonal antibody for the treatment of rheumatoid arthritis
August 1, 2008
Tocilizumab, an investigational agent for the treatment of moderate-to-severe rheumatoid arthritis, is a humanized anti-IL-6 receptor monoclonal antibody. Because tocilizumab contains a mouse monoclonal antibody grafted onto human immunoglobulin, the grafted antibody is less antigenic and has a longer half-life than the mouse antibody. When administered, tocilizumab inhibits IL-6 activity by competing for both the membrane-bound and soluble types of IL-6 receptors, thus eliminating IL-6 transduction into the cell.
Medication safety labeling updates and new warnings, August 2008
August 1, 2008
Labeling updates and warnings through August 2008 for abacavir (Ziagen) and abacavir-containing agents (Epzicom, Trizivir) and ciprofloxacin (Cipro), ciprofloxacin extended-release (Cipro XR. Proquin XR), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin).
Dronedarone associated with increased mortality in patients with severe heart failure
August 1, 2008
In the Antiarrhythmic Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA) investigators observed that dronedarone, an anti-arrhythmic agent related to amiodarone, was associated with increased mortality in patients who were hospitalized for symptomatic heart failure (HF) (New York Heart Association [NYHA] class II, III, or IV) and left ventricular systolic dysfunction.
FDA actions in brief, August 2008
August 1, 2008
Recent FDA approvals and indications (through August 2008) related to Concerta, Avodart, Prandimet, Trivaris, Reclast, Requip XL, Aciphex, Aptivus, Kinrix, Pentacel, and Durezol.
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