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Sleep medications increase risk for nighttime falls and potential injury

Adults who take one of the world's most commonly prescribed sleep medications are significantly more at risk for nighttime falls and potential injury, according to a new study by the University of Colorado at Boulder.

14 Jan 2011

Merck announces changes in vorapaxar clinical studies

Merck today provided the following statement on the changes to the clinical studies for vorapaxar, one of the Company's investigational cardiovascular medicines, following an announcement from the two academic centers leading the studies of vorapaxar.

14 Jan 2011

T.A. Sciences receives US patent for TA-65 to tackle aging process

Telomerase Activation Sciences, today announced the issuance of U.S. Patent No. 7,846,904 to the Geron Corporation. The patent covers the use of certain compounds to upregulate telomerase expression in cells.

14 Jan 2011

Adjunctive lacosamide reduces seizures and improves responder rates

Comprehensive analyses of pooled data from three randomized, double-blind, placebo-controlled Phase II/III trials showing the efficacy and tolerability of Vimpat® (lacosamide) C-V for patients with partial-onset seizures, regardless of the type of concomitant AED used, have been published in the drug evaluation journal, CNS Drugs.

13 Jan 2011

Antibiotics need to be used only when diagnosis of acute ear infection is certain

A new study showed that antibiotics are more effective than previously thought in the treatment of acute ear infection (namely acute otitis media) in young children. However, half of the children became better without antibiotics. Expectedly, antibiotics caused more adverse events. Antibiotics should be used only when the diagnosis of acute ear infection is certain.

13 Jan 2011

Researchers launch estrogen therapy trial to study depression, cardiovascular illness in women

Researchers at the University of North Carolina at Chapel Hill have launched a new clinical trial to determine if estrogen replacement therapy may help prevent depression and cardiovascular illness in women between the ages of 45 and 55.

13 Jan 2011

GSK, ChemoCentryx initiate '786 Phase III clinical trial for Crohn's disease

GlaxoSmithKline and ChemoCentryx, announced today that the first patient with Crohn's disease has initiated treatment in the initial pivotal induction study comparing Traficet-EN, now designated GSK1605786 ('786), to placebo.

12 Jan 2011

FDA panel rejects new pancreatic enzyme replacement drug

Eli Lilly & Co did not win the support of the U.S. advisory panel on Wednesday for its one-of-its kind drug not made from pig enzymes to help certain pancreatic patients digest food. A Food and Drug Administration panel of outside experts in a 7-4 vote said they were not convinced the experimental medicine, known chemically as liprotamase, worked well enough for patients to absorb enough needed nutrients. One member of the panel abstained.

12 Jan 2011

Antibiotics for ear infection in kids better than watchful waiting: Study

Findings from two latest clinical trials reveal that a young child with ear infections recovers faster and more completely if doctors give antibiotics right away rather than waiting to see if the kid get better on his/her own. One of the studies was in the U.S. and one in Finland. Earlier it has been debated that for young children with middle ear infections or otitis media whether immediate antibiotic treatment was better than watchful waiting. Current treatment recommendations in the U.S., Canada, and Europe allow for a watch-and-wait approach to suspected middle ear infections in young children. Change is coming, predicts study leader Alejandro Hoberman, MD, of Children’s Hospital of Pittsburgh.

12 Jan 2011

NSAIDs raise risk of heart disease: Study

A new study published online in the British Medical Journal explores the relative safety of non-steroidal anti-inflammatory medications (NSAIDs), commonly used to treat joint and muscle aches and pain and concludes that NSAIDs significantly increase the risk of cardiovascular events in patients who take them regularly.

12 Jan 2011

Daiichi Sankyo and ArQule initiate enrollment in ARQ 197 Phase 3 trial in NSCLC

Daiichi Sankyo Company, Limited and ArQule, Inc. today announced that the first patient has been enrolled in the Phase 3 trial of ARQ 197, an investigational selective inhibitor of the c-Met receptor tyrosine kinase, in combination with erlotinib, for patients diagnosed with non-squamous, non-small cell lung cancer (NSCLC) who have received one or two prior systemic anti-cancer therapies.

12 Jan 2011

UH, Case Western University commence clinical trial for bipolar disorder

The Mood Disorders Program at Case Western Reserve University School of Medicine and University Hospitals Case Medical Center, along with the Bipolar Trials Network, is launching Bipolar CHOICE.

12 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

Patients who consume painkillers may face cardiovascular risk

The drugs include traditional non-steroidal anti-inflammatory drugs as well as new generation anti-inflammatory drugs, known as COX-2 inhibitors. The researchers say that doctors and patients need to be aware that prescription of any anti-inflammatory drug needs to take cardiovascular risk into account.

12 Jan 2011

SciClone initiates phase 2b study of SCV-O7 for oral mucositis

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the enrollment of the first patient in the company's phase 2b clinical trial of SCV-07 for the prevention of oral mucositis (OM) -- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer.

11 Jan 2011

Bioheart announces primary focus on completing clinical evaluation of cell therapies for heart failure

Bioheart, Inc. announced today that Bioheart's primary focus is on completing clinical evaluation of its cell therapies for treating heart failure and related cardiac diseases.

11 Jan 2011

NPS completes treatment phase in GATTEX Phase 3 registration study in short bowel syndrome

NPS Pharmaceuticals, Inc. a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of the 24-week treatment phase of the company's Phase 3 registration study of GATTEX® (teduglutide).

11 Jan 2011

LibiGel may be the first FDA approved product to treat HSDD in menopausal women

BioSante Pharmaceuticals, Inc., a pharmaceutical company developing products for the treatment of female sexual health, today announced results of a survey of over 100 Obstetrician/Gynecologists and Primary Care Physicians regarding the need for an FDA-approved drug to treat a form of Female Sexual Dysfunction (FSD) known as Hypoactive Sexual Desire Disorder (HSDD).

11 Jan 2011

Shionogi brings KAPVAY ADHD drug to the U.S market

Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced a true milestone as it marks the first commercial availability for the non-central nervous system stimulant medication KAPVAY™, an extended-release oral formulation of clonidine for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

10 Jan 2011

Vicept reports positive data from V-101 Phase II clinical trial for Type I Rosacea

Vicept Therapeutics, Inc. announced positive study results from a Phase II clinical trial evaluating the dose-response relationship of four concentrations of V-101 cream, a topical cream for the treatment of Type I Rosacea (Erythematotelangiectatic Rosacea). The results demonstrated a statistically significantrebound" or tachyphylaxis was observed.

10 Jan 2011