Recent FDA approvals (through September 2009) related to Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, and Kogenate FS
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New molecular entity: Saxagliptin (Onglyza), a DPP-4 inhibitor, was approved on July 31, 2009, for the treatment of type 2 diabetes mellitus
New formulation: Sumatriptan (Sumavel DosePro) formulated as a needle-free injection was approved on July 15, 2009, for the acute treatment of migraine and cluster headaches
Recent FDA action (through September 2009) related to cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, and beclomethasone 17,21-dipropionate
Golimumab: A human anti-TNF-alpha monoclonal antibody for the treatment of autoimmune joint diseases
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Golimumab is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody that was recently approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Agents in late-stage development for the treatment of Crohn's disease, ulcerative colitis, irritable bowel syndrome, and short bowel syndrome
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has prematurely terminated a trial of sildenafil for the treatment of pulmonary arterial hypertension (PAH) in adult patients with sickle cell disease because of safety concerns.
After completing an analysis of safety data for tumor necrosis factor (TNF)-blockers, FDA has stated that there is an increased risk of lymphoma and other cancers in pediatric patients who are treated with these agents.
Lundbeck and Solvay have announced that they are discontinuing development of bifeprunox for the maintenance treatment of schizophrenia.
Lilly and BioMS Medical reported that their investigational agent dirucotide did not meet the primary end point of delaying disease progression in patients with secondary progressive multiple sclerosis (SPMS) in the phase 3 MAESTRO-01 trial.
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A study published in Urology demonstrated that alpha-blocker use is associated with a lower risk of sexual dysfunction in men aged >40 years.
Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients
With healthcare-reform legislation moving forward, insurers, providers, and pharmaceutical companies are keeping a sharp eye on policy proposals likely to affect coverage, costs, and benefits. Various constituencies in the healthcare community are supporting initiatives that will increase access to healthcare and make the nation's costly healthcare system more efficient and effective.
Emerging risk factors and risk markers for CV disease; Focus on rivaroxaban; Drug Watch: Agents in late-stage development for the treatment of osteoarthritis and acute/chronic pain
In a retrospective analysis published in the journal Neurology, investigators demonstrated that previous treatment with intravenous immunoglobulin (IVIg) was associated with a reduced risk of the development of Alzheimer's disease and related disorders (ADRD) in patients aged at least 65 years.
This review discusses emerging risk factors for CVD, including hs-CRP, lipoprotein(a), homocysteine, fibrinogen, homocysteine, and coronary artery calcification.
Recent FDA approvals (through August 2009) related to Ozurdex, Cambia, Ilaris, Feraheme, Plan B One-Step, Alimta, and Isentress
Rivaroxaban is a highly potent direct factor Xa inhibitor that is pending FDA approval for the indication of venous thromboembolism (VTE) prophylaxis in patients undergoing total knee replacement or total hip replacement surgery.
Recent FDA action (through August 2009) related to trazodone, casopitant, sertindole, alogliptin, bepotastine, trabectedin, and velaglucerase alfa
Generic drug approved by FDA (through August 2009): ethinyl estradiol/norgestimate tablets
New molecular entity: Dronedarone (Multaq), a benzofuran derivative, was approved on July 1, 2009, to reduce the risk of CV hospitalization in patients with AF
New molecular entity: Prasugrel (Effient), a platelet activation and aggregation inhibitor, was approved on July 10, 2009, to reduce the rate of thrombotic CV events in patients with ACS undergoing PCI
Agents in late-stage development for the treatment of osteoarthritis and acute/chronic pain
A matched, case-control analysis demonstrated an association between the use of stimulant medications (used to treat attention-deficit/hyperactivity disorder [ADHD]) and sudden unexplained death in children and adolescents.
Recent FDA approvals (through July 2009) related to Besivance, Taxus Liberte Atom Stent System, Risperdal Consta, Prograf, Zipsor, Sprycel, Axert, Caldolor, and Lamictal XR
Generic drug approved by FDA (through July 2009): melphalan injection
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