News

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.

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.

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.

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.

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.

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 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.

Federal and state governments may soon be looking to managed care for a comprehensive solution.

With increased coverage under the Patient Protection and Affordable Care Act (PPACA), insurers are expecting an influx of enrollees.

Differences in health status explain much of the regional variation in spending for privately insured people, but differences in provider prices-especially for hospital care-also play a key role.

Research indicates paying for a patient's entire care episode rather than individually for every test and treatment for certain procedures could save payers money.

Gay marriage makes headlines, but health coverage for domestic partners is quietly becoming more common as top employers seek ways to further define their corporate culture and provide attractive benefit plans.

With a year-end deadline looming, health Insurance companies who want to participate in PPACA's state-run exchanges have to be ready for anything.

FDA has approved alendronate sodium (Binosto, EffRx Pharmaceuticals) effervescent tablets, the first effervescent osteoporosis treatment in a buffered solution.

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 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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

Hepatitis C virus (HCV) infection

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.