Study shows CNS drugs take longer than others to develop, receive approval
March 16th 2012The 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.
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Study: Adding prednisone to rheumatoid arthritis treatment improves symptoms
March 16th 2012Patients' 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.
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Soldiers with PTSD, other mental health issues, more likely to get high-risk opioids
March 16th 2012Veterans 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.
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MALD model helps predict death versus recovery for APAP overdose
March 16th 2012A 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.
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FDA approves first oral contraceptive to treat heavy menstrual bleeding
March 15th 2012FDA 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.
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FDA approves first generic Lexapro to treat depression, anxiety disorder
March 14th 2012Teva/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.
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FDA approves first cell-based product to treat oral mucogingival conditions in adults
March 9th 2012FDA 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.
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Some antipsychotics more dangerous for elderly dementia patients
March 9th 2012Antipsychotic 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.
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Bevacizumab improves vision for patients with AMD
March 9th 2012A 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.
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NAMS highlights benefit-risk ratio of hormone therapy for menopause
March 9th 2012The 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.
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FDA panel recommends approval of aclidinium bromide for COPD
March 9th 2012An 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.
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First synthetic, peptide-containing surfactant for prevention of RDS approved
March 9th 2012FDA 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.
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FDA approves first synthetic, peptide-containing surfactant for prevention of RDS
March 7th 2012FDA 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.
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FDA: Co-administration of statins and protease inhibitors increases risk of muscle injury
March 2nd 2012Thursday, 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.
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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.
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International Stroke Conference 2012: Service encourages teens to text health-related questions
March 1st 2012A 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.
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