Formulary Watch |
All News - Page 139
Study shows CNS drugs take longer than others to develop, receive approval
March 16, 2012
The time from investigational new drug application filing to NDA/BLA approval by FDA of drugs for central nervous system disorders and the subsequent regulatory approval can take 35% longer than other therapeutic categories, according to a recent analysis published in the March/April Tufts Center for the Study of Drug Development Impact Report.
Study: Adding prednisone to rheumatoid arthritis treatment improves symptoms
March 16, 2012
Patients' rheumatoid arthritis symptoms improved after adding prednisone at the start of a methotrexate-based treatment strategy, according to research published in the March 6 issue of the Annals of Internal Medicine.
Aspirin may reduce incidence of strokes in postmenopausal women with high trans-fat intake
March 16, 2012
Postmenopausal women with a higher intake of trans fat have a higher incidence of ischemic stroke, but aspirin may reduce the adverse effects of trans fat, according to a new study.
Soldiers with PTSD, other mental health issues, more likely to get high-risk opioids
March 16, 2012
Veterans of Afghanistan and Iraq with mental health issues, especially post-traumatic stress disorder (PTSD), were more likely to receive high-risk opioids for pain, and those with PTSD were more likely to suffer adverse clinical outcomes, according to a new study.
TAK-875 controls blood sugar, reduces hypoglycemia risk
March 16, 2012
An experimental diabetes drug, TAK-875, demonstrated its ability to improve blood-sugar control with a low risk of hypoglycemia, according to phase 2 study results published online February 27 in The Lancet.
MALD model helps predict death versus recovery for APAP overdose
March 16, 2012
A mathematical model that uses laboratory values commonly available on admission can help physicians estimate acetaminophen (APAP: N-acetyl-para-aminophenol) overdose amount, time elapsed since overdose, and potential outcome, according to a study published online February 13 in Hepatology.
FDA approves first oral contraceptive to treat heavy menstrual bleeding
March 15, 2012
FDA has approved a new indication for estradiol valerate and estradiol valerate/dienogest (Natazia, Bayer HealthCare Pharmaceuticals) tablets for the treatment of heavy menstrual bleeding (HMB) that is not caused by any diagnosed conditions of the uterus.
FDA approves first effervescent osteoporosis treatment in a buffered solution
March 14, 2012
FDA has approved alendronate sodium (Binosto, EffRx Pharmaceuticals) effervescent tablets, the first effervescent osteoporosis treatment in a buffered solution.
FDA approves first generic Lexapro to treat depression, anxiety disorder
March 14, 2012
Teva/IVAX Pharmaceuticals gained FDA approval for the first generic version of Lexapro (Forest) to treat both depression and generalized anxiety disorder in adults. The company will have 180 days to exclusively sell the product.
FDA approves first cell-based product to treat oral mucogingival conditions in adults
March 9, 2012
FDA approved the first cell-based product made from allogeneic human cells and bovine collagen (Gintuit, Organogenesis) for in the treatment of mucogingival conditions in adults, the agency announced Friday.
Some antipsychotics more dangerous for elderly dementia patients
March 9, 2012
Antipsychotic medication should be used on elderly dementia patients only in cases of clear need, authors of a recent study said, but they found that some antipsychotics are more dangerous than others after examining data from thousands of nursing-home residents aged 65 or older.
Bevacizumab improves vision for patients with AMD
March 9, 2012
A treat-and-extend regimen of intravitreal bevacizumab (Avastin, Genentech) produced "significant visual improvements" for eyes with neovascular age-related macular degeneration, according to an article published in the March issue of the American Journal of Ophthalmology.
NAMS highlights benefit-risk ratio of hormone therapy for menopause
March 9, 2012
The 2012 Hormone Therapy Position Statement of The North American Menopause Society (NAMS) updates the evidence-based position statement published by NAMS in 2010 regarding recommendations for hormone therapy for postmenopausal women.
AAP now recommends HPV vaccine for boys
March 9, 2012
New guidelines for the use of the quadrivalent human papillomavirus vaccine, published by the American Academy of Pediatrics, recommend for the first time vaccinating adolescent boys as well as girls.
FDA panel recommends approval of aclidinium bromide for COPD
March 9, 2012
An FDA advisory panel voted 12-2 to recommend approval of aclidinium bromide (Forest Laboratories and Almirall SA) 400 µg twice daily for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
First synthetic, peptide-containing surfactant for prevention of RDS approved
March 9, 2012
FDA has approved lucinactant (Surfaxin, Discovery Labs) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. Surfaxin is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine.
FDA approves first synthetic, peptide-containing surfactant for prevention of RDS
March 7, 2012
FDA has approved lucinactant (Surfaxin, Discovery Labs) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. Surfaxin is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine.
Careers Page for Medical and Healthcare Executives
March 2, 2012
Visit our Careers page for Medical and Healthcare Executives, which is updated regularly, to search for postings by date, location, and company name. You may also research salaries by using the PayScale tool link on the site.
FDA: Co-administration of statins and protease inhibitors increases risk of muscle injury
March 2, 2012
Thursday, FDA updated its recommendations concerning drug-drug interactions between protease inhibitors and statins, warning of an increased risk of muscle injury (myopathy). The most serious form of myopathy, rhabdomyolysis, can damage kidneys and lead to kidney failure, which can be fatal.
International Stroke Conference 2012: Mobile health service serves as catalyst to maternal, infant well-being
March 1, 2012
Despite decades of public health outreach and education, more than 500,000 premature babies are born in the United States each year with approximately 28,000 children dying before their first birthday, according to research presented at the Mobile Healthcare Communications 2012: Case Studies and Roundtables, hosted by Business Development Institute, in New York City.
International Stroke Conference 2012: Service encourages teens to text health-related questions
March 1, 2012
A text messaging service for teens attending the Mount Sinai Adolescent Health Center (MSAHC) in New York, enables them to ask confidential questions, sign up for birth-control reminders, and receive weekly 'healthbytes' of health-based advice.
Pneumococcal 13-valent conjugate vaccine (Prevnar 13): A pneumococcal polysaccharide conjugated to carrier protein diphtheria CRM197 for the prevention of pneumonia and invasive pneumococcal disease in adults aged 50+ years
March 1, 2012
New indication: Pneumococcal 13-valent conjugate vaccine (Prevnar 13) was granted accelerated FDA marketing approval for the prevention of pneumonia and invasive disease (infection of blood or spinal fluid) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults age 50 years and older.
International Stroke Conference 2012: Anticlotting agents offer similar prevention rates of stroke, death in heart failure patients with normal heart rhythm
March 1, 2012
Warfarin is similar to aspirin in preventing deaths and strokes in patients with heart failure and normal heart rhythm, according to the largest and longest head-to-head comparison study of the 2 anticlotting drugs.
Immunotherapy shown to extend life expectancy in metastatic prostate cancer
March 1, 2012
A new analysis of the phase 3 IMPACT study has found that sipuleucil-T (Provenge, Dendreon) increases survival times by an estimated median of 7.8 months in patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.
FDA Actions in Brief March 2012 (Corcept Therapeutics, Merck, Amylin Pharmaceuticals, Alkermes, Sanofi, Mobius Therapeutics, Vertex Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Pfizer, UCB, Curis, Genentech, Novartis)
March 1, 2012
Recent FDA Approvals (through February 2012) related to (Corcept Therapeutics, Merck, Amylin Pharmaceuticals, Alkermes, Sanofi, Mobius Therapeutics, Vertex Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Pfizer, UCB, Curis, Genentech, Novartis)
Racial/ethnic disparities exist in the diagnosis, treatment of depression
March 1, 2012
Minorities are less likely to receive a depression diagnosis and be treated for it than non-Hispanic Whites, according to a new study published on-line and ahead-of-print on December 15, 2011, in the American Journal of Public Health.
Patients becoming more aware that drugs safe, effective for psychological, behavioral disorders
March 1, 2012
The increase in utilization of medications for psychological and behavioral disorders can be attributed to greater awareness among patients that mental health disorders are treatable and that available drug therapies are safe and effective, according to David Muzina, MD, a national practice leader of the Medco Neuroscience Therapeutic Resource Center.
