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All News - Page 171
FDA actions in brief, September 2009 (Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, Kogenate FS)
September 1, 2009
Recent FDA approvals (through September 2009) related to Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, and Kogenate FS
Saxagliptin (Onglyza): DPP-4 inhibitor approved for the treatment of type 2 diabetes mellitus
September 1, 2009
New molecular entity: Saxagliptin (Onglyza), a DPP-4 inhibitor, was approved on July 31, 2009, for the treatment of type 2 diabetes mellitus
Sumatriptan (Sumavel DosePro): Needle-free injection of 5-HT1 receptor agonist approved for the acute treatment of migraine and cluster headaches
September 1, 2009
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
FDA Pipeline preview, September 2009 (cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, beclomethasone 17,21-dipropionate)
September 1, 2009
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
September 1, 2009
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.
Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders (September 2009) (PDF)
September 1, 2009
Agents in late-stage development for the treatment of Crohn's disease, ulcerative colitis, irritable bowel syndrome, and short bowel syndrome
Trial of sildenafil for PAH in patients with sickle cell disease terminated because of safety concerns
August 18, 2009
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.
New warnings about malignancies in pediatric patients added to labels of TNF-blockers
August 18, 2009
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.
Development of bifeprunox for maintenance treatment of schizophrenia discontinued
August 18, 2009
Lundbeck and Solvay have announced that they are discontinuing development of bifeprunox for the maintenance treatment of schizophrenia.
Dirucotide trials for secondary progressive MS discontinued for lack of efficacy
August 18, 2009
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.
Alpha-blocker use in men associated with decreased incidence of sexual dysfunction
August 18, 2009
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
August 18, 2009
Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients
Healthcare reform to shape drug coverage, costs, and R&D
August 18, 2009
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.
Formulary Digital Edition August 2009
August 1, 2009
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
IVIg treatment associated with a reduced risk of Alzheimer's disease
August 1, 2009
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.
Emerging risk factors and risk markers for cardiovascular disease: Looking beyond NCEP ATP III
August 1, 2009
This review discusses emerging risk factors for CVD, including hs-CRP, lipoprotein(a), homocysteine, fibrinogen, homocysteine, and coronary artery calcification.
FDA actions in brief, August 2009 (Ozurdex, Cambia, Ilaris, Feraheme, Plan B One-Step, Alimta, Isentress)
August 1, 2009
Recent FDA approvals (through August 2009) related to Ozurdex, Cambia, Ilaris, Feraheme, Plan B One-Step, Alimta, and Isentress
Rivaroxaban: A direct factor Xa inhibitor for VTE prophylaxis in patients undergoing total knee or hip replacement surgery
August 1, 2009
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.
FDA Pipeline preview, August 2009 (trazodone, casopitant, sertindole, alogliptin, bepotastine, trabectedin, velaglucerase alfa)
August 1, 2009
Recent FDA action (through August 2009) related to trazodone, casopitant, sertindole, alogliptin, bepotastine, trabectedin, and velaglucerase alfa
First-time generic drug approval, August 2009
August 1, 2009
Generic drug approved by FDA (through August 2009): ethinyl estradiol/norgestimate tablets
Dronedarone (Multaq): Benzofuran derivative approved to reduce the risk of CV hospitalization in patients with AF
August 1, 2009
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
Prasugrel (Effient): Platelet activation and aggregation inhibitor approved to reduce the rate of thrombotic CV events in patients with ACS undergoing PCI
August 1, 2009
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
Drug Watch: Agents in late-stage development for the treatment of osteoarthritis and acute/chronic pain (August 2009) (PDF)
August 1, 2009
Agents in late-stage development for the treatment of osteoarthritis and acute/chronic pain
ADHD medications may be linked to sudden unexplained death
July 1, 2009
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.
FDA actions in brief, July 2009 (Besivance, Taxus Liberte Atom Stent System, Risperdal Consta, Prograf, Zipsor, Sprycel, Axert, Caldolor, Lamictal XR)
July 1, 2009
Recent FDA approvals (through July 2009) related to Besivance, Taxus Liberte Atom Stent System, Risperdal Consta, Prograf, Zipsor, Sprycel, Axert, Caldolor, and Lamictal XR
First-time generic drug approval, July 2009
July 1, 2009
Generic drug approved by FDA (through July 2009): melphalan injection
Therapeutic considerations in managing multiple myeloma
July 1, 2009
This review highlights treatment guidelines, disease staging criteria, and new therapeutic approaches to MM, including an overview of supportive care and emerging pipeline agents.
Tadalafil (Adcirca): Phosphodiesterase type 5 inhibitor approved for the treatment of pulmonary arterial hypertension (WHO Group I)
July 1, 2009
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)
Tolvaptan (Samsca): Vasopressin receptor antagonist approved for the treatment of clinically significant hypervolemic and euvolemic hyponatremia
July 1, 2009
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
FDA Pipeline preview, July 2009 (bucindolol, botulinum toxin type A, rivaroxaban, quetiapine, olanzapine, ziprasidone, ofatumumab, pegloticase, pralatrexate, melphalan, paclitaxel)
July 1, 2009
Recent FDA action (through July 2009) related to bucindolol, botulinum toxin type A, rivaroxaban, quetiapine, olanzapine, ziprasidone, ofatumumab, pegloticase, pralatrexate, melphalan, and paclitaxel
