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Kennedy Krieger Institute launches phase II clinical trial to investigate Revatio for DMD treatment

Kennedy Krieger Institute announced today the launch of a first‐of‐its‐kind, phase II clinical trial to investigate a treatment for heart disease in individuals with Duchenne muscular dystrophy (DMD).

13 Oct 2010

US Oncology enrolls 1,000th patient in Phase I clinical trial

US Oncology, Inc., the nation's leading integrated oncology company, announced today that it has enrolled the 1,000th patient in a Phase I clinical trial through its US Oncology Research Network. Phase I clinical trials present special challenges, including increased safety concerns, higher variability of patient disease, more complex trial designs, and some first-in-human trials, making Phase I trials more difficult to operate in the community setting.

13 Oct 2010

Alkermes' VIVITROL medication for treatment of opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL(naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence, following opioid detoxification.

13 Oct 2010

FDA approves Vivitrol for treatment of opioid-dependent patients

The U.S. Food and Drug Administration today approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.

13 Oct 2010

Smart for Life(R) to add Lepticore(R) to product line

Smart for Life(R), the trailblazing company featuring weight management products will begin adding Lepticore(R) to its product line this month.

12 Oct 2010

Alimera to present Iluvien Phase 3 clinical trial data at AAO annual meeting

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that data from its Phase 3 (FAME) clinical trials for Iluvien will be presented this month at the annual meeting of the American Academy of Ophthalmology (AAO) in Chicago.

12 Oct 2010

EMA approves TWYNSTA therapy that reduces BP in hypertensive patients

Boehringer Ingelheim announced today that the European Commission confirmed the positive opinion of the European Medicines Agency (EMA) approving TWYNSTA. TWYNSTA is indicated for the treatment of hypertension in adults whose blood pressure is not adequately controlled on amlodipine or as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets containing the same component doses.

12 Oct 2010

Older people who do not get vaccinated rely on indigenous health practices

Eating steamed pears, having a soothing massage or bathing in a herbal mixture are just some of indigenous health practices used by older people to ward off or treat influenza, according to research published in the October issue of the Journal of Advanced Nursing.

12 Oct 2010

First presentation of anti-HER2 antibody-drug conjugate as first-line therapy for advanced breast cancer

A new type of breast cancer treatment has shown encouraging activity as a first-line therapy in HER2-positive metastatic disease, researchers reported at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy.

12 Oct 2010

Albireo reports positive results from A3309 Phase IIb study in chronic idiopathic constipation

Albireo today announced positive top-line results from a Phase IIb study in chronic idiopathic constipation (CIC) assessing efficacy and safety of three different dose levels (5, 10 and 15 mg orally once a day) of the investigational drug A3309 during an eight week trial. Analyses of the data show clinically meaningful and statistically significant improvement for patients treated with A3309 compared to placebo-treated patients.

12 Oct 2010

Helix completes GLP toxicology study milestone in L-DOS47 development program

Helix BioPharma Corp. today announced that it has completed its definitive GLP, rodent and primate, repeat-dose toxicology studies with L-DOS47. These studies demonstrated a good safety profile in an expanded number of rodent and primate test animals, building upon Helix's positive findings from its preliminary non-GLP toxicology studies.

12 Oct 2010

Essentialis receives patent for active component in DCCR product

Essentialis, Inc. announced today that the United States Patent & Trademark Office (USPTO) has issued U.S. Patent No. 7,799,777 entitled Salts of potassium ATP channel openers and uses thereof. The patent claims a novel composition of a polymorph of diazoxide choline, the active ingredient in the Essentialis lead product, DCCR. Essentialis has successfully completed phase 2b clinical trials with DCCR, showing a highly significant triglyceride reduction in dyslipidemic patients.

12 Oct 2010

Carotid artery stenting increases risk of death, stroke

For patients with blockages in the carotid artery that supplies blood to the brain, carotid artery stenting (a non-surgical treatment) appears to be associated with an increased risk of both short- and long-term adverse outcomes when compared with surgical treatment (carotid endarterectomy), according to a meta-analysis of previously published studies that was posted online today and will appear in the February 2011 print issue of Archives of Neurology, one of the JAMA/Archives journals.

12 Oct 2010

Combination therapy for ovarian cancer leads to greater toxicity

Adding topotecan to carboplatin plus paclitaxel, the standard treatment for ovarian cancer, does not improve progression-free survival in patients and leads to greater toxicity, according to a study published online October 11 in the Journal of the National Cancer Institute.

12 Oct 2010

HHS awards $5 million grant to support teen pregnancy prevention programs

The George Washington University School of Public Health and Health Services (SPHHS), in partnership with three community-based organizations, has been awarded a five-year, $5 million grant from the Department of Heath and Human Service's (HHS) Office of Adolescent Health. This grant is part of a $155 million commitment by HHS to support the replication of teen pregnancy prevention programs that have been shown to be effective through rigorous research as well as the testing of new, innovative approaches to combating teen pregnancy.

12 Oct 2010

Phase 3 study shows everolimus delays tumor progression in hard-to-treat neuroendocrine tumors

The results of a large Phase-III clinical trial have shown that the drug everolimus delays tumor progression in patients with a hard-to-treat group of rare cancers that affect particular hormone-producing cells.

11 Oct 2010

Early cancer drug trials flawed by inconsistencies in prohibited drug lists, study finds

Researchers in Canada and France have raised concerns about substantial inconsistencies in a basic aspect of the way Phase-I and Phase-II cancer clinical trials are designed.

11 Oct 2010

Embryonic stem cells used in first trial for spinal cord injury

The first ever patient to receive treatment in a U.S. government approved study involving human embryonic stem cells has been injected with millions of the potentially life saving cells. He is presently being treated at the Shepherd Center in Atlanta. He was partially paralyzed following a spinal cord injury. The center specializes in treating these types of injuries.

11 Oct 2010

CTCA in Tulsa purchases BSD-2000 Hyperthermia System

BSD Medical Corporation announced today that the Cancer Treatment Centers of America (CTCA), located in Tulsa, Oklahoma, has purchased a BSD-2000 Hyperthermia System (BSD-2000). CTCA in Tulsa is a state-of-the-art hospital that is totally focused on treating cancer patients and provides the most advanced therapeutic resources in cancer treatment.

11 Oct 2010

Gelesis presents lead products data at Obesity 2010 Annual Meeting

Gelesis, Inc., a Boston-based company focused on breakthrough treatments for obesity, presented new results at Obesity 2010, the 28th Annual Scientific Meeting of The Obesity Society (San Diego). The new data demonstrated that its lead products (Attiva and Gellica) dramatically reduced food intake in a gold-standard animal model compared to administration of an equal amount of water.

11 Oct 2010