Lundbeck and Solvay have announced that they are discontinuing development of bifeprunox for the maintenance treatment of schizophrenia.
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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.
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.
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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
This review highlights treatment guidelines, disease staging criteria, and new therapeutic approaches to MM, including an overview of supportive care and emerging pipeline agents.
New indication: Tadalafil (Adcirca), a phosphodiesterase type 5 inhibitor, was approved on May 22, 2009, for the treatment of pulmonary arterial hypertension (WHO Group I)
New molecular entity: Tolvaptan (Samsca), a vasopressin receptor antagonist, was approved on May 19, 2009, for the treatment of clinically significant hypervolemic and euvolemic hyponatremia
Recent FDA action (through July 2009) related to bucindolol, botulinum toxin type A, rivaroxaban, quetiapine, olanzapine, ziprasidone, ofatumumab, pegloticase, pralatrexate, melphalan, and paclitaxel
Milnacipran was recently approved by FDA for the management of fibromyalgia syndrome. Clinical trials have demonstrated that this agent may be a reasonable alternative or adjunct therapy for patients with fibromyalgia syndrome who are unable to tolerate first-line tricyclic antidepressant therapy.
New indication: Zoledronic acid (Reclast), a bisphosphonate, was approved on May 29, 2009, for the prevention of osteoporosis in postmenopausal women
Dutasteride reduces the risk of biopsy-detectable prostate cancer by approximately one-fourth in men at high risk for the disease without increasing the risk of high-grade cancers, said Gerald L. Andriole, Jr, MD, at the American Urological Association (AUA) 2009 Annual Meeting.
Pfizer is discontinuing a phase 3 study of sunitinib plus paclitaxel versus bevacizumab plus paclitaxel for the first-line treatment of patients with advanced breast cancer.
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