A high proportion of pediatric, randomized controlled trials (RCTs) have a high risk for bias, particularly those that are industry-funded or involve assessment of behavioral/educational interventions, but trial registration is linked to less risk of bias, according to research published online July 12 in Pediatrics, HealthDay News reported.
Investigational triple antihypertensive combination therapy lowers blood pressure more effectively than dual therapy in diabetic patients with hypertension, according to the results of a subgroup analysis of the TRINITY study.
Sandoz, the generics division of Novartis, is the first company to receive US approval to market a generic version of the leading hospital-based medication, Lovenox (enoxaparin sodium), the ?gold standard? in anti-thrombotic treatment. No sooner did Sandoz begin shipments of the generic version, Sanofi-Aventis, manufacturer of Lovenox, filed a lawsuit to prevent the approval of the generic. Last year, Lovenox recorded $4.57 billion in sales for Sanofi-Aventis, according to IMS Health. Both the new generic and Lovenox are low-molecular-weight heparin anticoagulants that help prevent deep vein thrombosis.
Major molecular responses are more common with the next generation of tyrosine kinase inhibitors as first-line options compared with imatinib for the treatment of newly diagnosed patients with chronic myelogenous leukemia (CML). Two separate studies confirmed superior response rates with dasatinib and nilotonib versus the current first-line standard imatinib.
Continuous daily sunitinib significantly improves overall survival and progression-free survival (PFS) in patients with advanced pancreatic neuroendocrine tumors, according to data from a phase 3 study.
The use of lorcaserin, along with behavioral modification, is associated with weight loss and subsequent weight maintenance compared with placebo, according to a study published in the July 15 issue of the New England Journal of Medicine, HealthDay News reported.
Meningococcal polysaccharide vaccine (MPV4) does not appear to be associated with post-vaccination Henoch-Schönlein purpura (HSP) in 16- to 20-year-olds, according to research published online July 12 in Pediatrics, HealthDay News reported.
A high proportion of pediatric, randomized controlled trials (RCTs) have a high risk for bias, particularly those that are industry-funded or involve assessment of behavioral/educational interventions, but trial registration is linked to less risk of bias, according to research published online July 12 in Pediatric, HealthDay News reported.
Disease-modifying therapy in adult relapsing-remitting multiple sclerosis; Focus on fingolimod; Agents in late-stage development for the management of weight
Weight management agents in late-stage development.
Recent FDA Approvals (through July 2010) related to Tribenzor, Daiichi Sankyo, Aricept, Eisai and Pfizer, Daytrana, Glassia, Zuplenz, Infergen, Cuvposa
Fingolimod is an investigational drug being studied for the treatment of relapsing-remitting multiple sclerosis (RRMS) and may represent a first-in-class sphingosine 1-phosphate receptor modulator as well as the first oral therapy for the treatment of RRMS.
Multiple sclerosis (MS) is a significant cause of disability among young adults, more commonly women, and usually strikes patients in the prime of their lives. Despite recent therapeutic advancements, MS remains an incurable, chronic illness. Clinical evidence supports the role of disease-modifying therapy early in the disease course to reduce the number of acute attacks, delay disease progression, maintain quality of life, and prevent disability.
In patients with low back pain of at least moderate severity and lasting for at least 6 weeks, a new 7-day buprenorphine transdermal system was found to provide better pain control, improve sleep quality, and health-related quality of life as compared with placebo.
New Formulation: Buprenorphine (Butrans) was approved in June for the management of moderate-to-severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.
On July 8, FDA released a "Drug Safety Communication" warning that off-label use of quinine sulfate (Qualaquin, AR Scientific) to treat night-time leg cramps has been found to result in serious and life-threatening adverse effects.
A systematic review and meta-analysis conducted by researchers at Case Western Reserve University School of Medicine and University Hospitals Case Medical Center, Cleveland, suggests that angiotensin-receptor blockers (ARBs) are associated with "a modestly increased risk" of developing cancer (RR increase of 8%, P=.016).
Generic drugs approved by FDA (through July 2010): Naratriptan hydrochloride tablets, Famotidine for oral suspension, Adapalene cream, Enoxaparin sodium injection, Oxymorphone hydrochloride
New Combination: Mometasone furoate and formoterol fumarate dihydrate (Dulera) was approved in June for the treatment of asthma in patients ?12 years of age.
Seven-day, transdermal buprenorphine patches are as effective as sublingual buprenorphine in the treatment of patients with osteoarthritis pain, according to a randomized, double-blind clinical trial recently published on-line ahead of print in the Journal of Pain and Symptom Management.
A number of high-profile drug and biotech manufacturing breakdowns in recent months is raising questions about industry investment in, and commitment to, modern production systems able to meet FDA standards.
The application of pharmacogenomics-the science of how genetic variations influence drug response-is new to the field of health benefit management, and its potential to improve care and reduce costs is significant.
Women who suffer from endometriosis-related pain should be treated first with conservative, non-surgical approaches and then with more invasive options if pain does not resolve, and hysterectomy only as a last resort, according to a practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) and published in the July issue of Obstetrics & Gynecology, reported HealthDay News.
Recent clinical practice guidelines offer similar recommendations for assessing and managing low back pain, and clinicians can improve patient care by adopting these recommendations, according to a review published in the June issue of The Spine Journal, reported HealthDay News.
Supplementation with folic acid and vitamin B12 over an extended period does not have a beneficial effect on vascular outcomes in individuals who have had a myocardial infarction, but it also poses no excess cancer risk, according to a study in the June 23/30 issue of the Journal of the American Medical Association, reported HealthDay News.
Women taking adjuvant tamoxifen for early-stage breast cancer who develop a thromboembolism (TE) are nearly 5 times more likely to carry the factor V Leiden mutation than women on the medication who don't have a TE, according to a study published online June 16 in the Journal of the National Cancer Institute, reported HealthDay News.
