Recent FDA action (through, March 2011) related to Salix, Protalix, Amyvid, indacaterol, Istodax, Mucin 1 targeting peptide GO-203-2c, Intercept plasma, Lomitapide, Liver cell therapy.
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New molecular entity: Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine was approved by FDA to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons aged 2 to 55 years.
In a new study published ahead of print on the Mayo Clinic Proceedings website, researchers demonstrated that the cost of medications was a factor influencing the proportion of patients with heart failure who had poor medication adherence to beta-blockers, angiotensin converting-enzyme inhibitors or receptor blockers, and statins.
The management of type 2 diabetes mellitus needs to change in response to the evolving evidence base now available. Research from the ADVANCE and the ACCORD trials was presented during the American Diabetes Association 58th annual advanced postgraduate course in New York City.
Overall, it would not appear that the new erythropoiesis-stimulating agents for treatment of cytopenia will add substantially to pharmacy budgets. As they are approved by FDA, each medication will need to be reviewed to understand its complete clinical advantage, and the safety profile will need to be completely understood.
New indication: Hydroxyprogesterone caproate injection was approved by FDA in February to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of at least 1 spontaneous preterm birth.
An update on the management of atrial fibrillation issued by a task force consisting of the American College of Cardiology Foundation, the American Heart Association, and the Heart Rhythm Society has incorporated dabigatran into its recommendations.
Despite advancements, treatment of metastatic breast cancer hinges on multifarious factors and numerous unanswered questions about therapy linger. Agents that are highly active in heavily pretreated patients are needed to optimize outcomes in patients with metastatic disease. This article reviews current and novel treatment options for metastatic breast cancer.
FDA approved belimumab (Benlysta, Human Genome Sciences and GlaxoSmithKline) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus who are receiving standard therapy.
FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.
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FDA has approved an expanded age indication for Zoster Vaccine Live, (Zostavax, Merck) for the prevention of herpes zoster, commonly known as shingles, in adults ages 50 years and older.
The use of angiotensin-receptor blockers alone are not associated with increased odds of cancer or cancer-related death, according to a meta-analysis published in a recent edition of Lancet Oncology.
FDA and the European Medicines Agency have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design, of new drug marketing applications that are submitted to both agencies.
Dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) capsules have received tier 2 formulary status with 2 key pharmacy benefit managers.
FDA released a safety communication to update prescribers and patients about the ongoing review of insulin glargine (Lantus) that was initiated in July 2009.
A substantial portion of antiretroviral-naïve patients are infected with transmitted drug-resistant HIV with one or more drug-resistant mutations, and they are much more likely to experience treatment failure, according to research published in The Lancet Infectious Diseases.
Patients with psoriatic arthritis undergoing their first treatment with tumor necrosis factor-? inhibitor showed a high adherence to therapy and a good response, according to a recent Danish study published in Arthritis & Rheumatism.
Many patients, especially those with limited literacy, do not consolidate prescription medication regimens efficiently, which could lead to nonadherence, according to a recent study in the Archives of Internal Medicine.
The willingness of the elderly to take medication for primary cardiovascular disease prevention is relatively insensitive to its benefit but highly sensitive to its adverse effects, according to a recent study published in the Archives of Internal Medicine.
FDA has approved a change to the prescribing information for ambrisentan 5-mg and 10-mg tablets (Letairis, Gilead Sciences) once-daily treatment to improve exercise ability and delay clinical worsening in patients with pulmonary arterial hypertension (PAH, WHO Group 1) and predominantly WHO Functional Class II-III symptoms.
The risk of certain birth defects is higher in women given opioid analgesics such as hydrocodone during pregnancy, according to a new study.
FDA recently announced its plans to remove certain unapproved prescription medicines used to treat cough, cold, and allergy symptoms.
Children aged 6 to 23 months who receive trivalent inactivated flu vaccine concurrently with the 13-valent pneumococcal conjugate vaccine are at increased risk of febrile seizures, according to researchers at the Centers for Disease Control and Prevention in Atlanta and Harvard Medical School in Boston.
The angiogenesis inhibitor bevacizumab, used with chemotherapy or biological therapy, carries an increased risk of treatment-related death in cancer patients compared with chemotherapy alone, a new study shows.
The anticancer drug bevacizumab could help prevent babies with retinopathy of prematurity from becoming blind, reports a new study from the University of Texas Health Science Center at Houston Medical School.
FDA has updated the pregnancy section of drug labels for the entire class of antipsychotic medications to provide more information about the potential risk of extrapyramidal signs and withdrawal symptoms in newborns whose mothers take antipsychotics during the third trimester of pregnancy.
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