The Food and Drug Administration (FDA) approved Aricept (donepezil hydrochloride) for the treatment of severe dementia in patients with Alzheimer’s Disease.
The first long-term, large-scale study designed to determine the safety and effectiveness of treating preschoolers who have attention deficit/hyperactivity disorder (ADHD) with methylphenidate (Ritalin) has found that overall, low doses of this medication are effective and safe. However, the study found that children this age are more sensitive than older children to the medication?s side effects and therefore should be closely monitored. The 70-week, six-site study was funded by the National Institutes of Health?s National Institute of Mental Health (NIMH) and was described in several articles in the November 2006 issue of the Journal of the American Academy of Child and Adolescent Psychiatry.
The drug misoprostol provides a safe, convenient, and inexpensive means to prevent postpartum hemorrhage, a major killer of women in developing countries. The study was conducted by researchers from the University of Missouri, India?s Jawaharlal Nehru Medical College, the National Institutes of Health, and other institutions.
Americans accustomed to the seasonal misery of sneezing, runny noses and itchy, watery eyes caused by ragweed pollen might one day benefit from an experimental allergy treatment that not only requires fewer injections than standard immunotherapy, but leads to a marked reduction in symptoms that persists for at least a year after therapy has stopped, according to a new study in the October 5 issue of The New England Journal of Medicine (NEJM). The research was sponsored by the Immune Tolerance Network, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both components of the National Institutes of Health (NIH), and the Juvenile Diabetes Research Foundation International.
Researchers at the University of California, San Francisco (UCSF) have discovered a gene mutation in fruit flies that alters sensitivity to alcohol. The findings, reported in the October 6 issue of the journal Cell, may have implications for human studies seeking to understand innate differences in people?s tolerance for alcohol. The research was supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services.
Scientists at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other institutions have demonstrated for the first time that a single drug can rebuild damaged muscle in two strains of mice that develop diseases comparable to two human forms of muscular dystrophy. This advance, which is reported online in Nature Medicine, is the latest from a research collaboration that began several years ago by the teams of Vittorio Sartorelli, M.D., at NIAMS and Pier Lorenzo Puri, M.D., Ph.D., now at Dulbecco Telethon Institute (DTI) in Rome, Italy and The Burnham Institute in La Jolla, Calif.
Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) for bifeprunox, an investigational atypical antipsychotic for the treatment of schizophrenia.
Anesiva, Inc. (Nasdaq: ANSV) announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug status to product candidate 4975 for the treatment of a painful condition in the foot known as interdigital neuroma in patients who fail conservative treatments, such as foot pads, NSAID’s (non-steroidal anti-inflammatory drugs) and injections of corticosteroids, that would otherwise require removing or chemically destroying the nerve that causes the pain. Orphan drug designation is granted by the FDA to encourage companies to develop products that treat rare diseases and conditions and includes incentives such as market exclusivity for seven years, tax credits on qualified clinical trial expenses and a waiver of the FDA prescription drug user fees.
TriPath Imaging Inc. (Nasdaq: TPTH) and Ventana Medical Systems, Inc. (Nasdaq: VMSI), announced today that TriPath Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for the Ventana Image Analysis System (VIAS(TM)) when used with tissues stained for p53. In 2005 and 2006, the Companies announced 510(k) clearances for VIAS when used with the Ventana Estrogen Receptor (ER), Progesterone Receptor (PR), Ki-67 and HER- 2/neu assays.
Agennix today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company’s oral formulation of Talactoferrin Alfa (talactoferrin or TLF) for the treatment of renal cell carcinoma (RCC). Oral TLF is currently in Phase II clinical development for RCC. Results from a multi-center Phase 2 RCC trial that included six leading U.S. cancer centers were presented at the 2006 Annual meeting of the American Society of Clinical Oncology (ASCO).