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Researchers evaluate efficacy of GKRS in patients with pituitary adenoma

In 2009, it was estimated that a total of 22,070 new cases of brain and other CNS tumors were diagnosed. Pituitary adenomas represent one of the most common brain tumors. Large studies report that approximately 10-20 percent of the population harbors a pituitary tumor. According to the Central Brain Tumor Registry of the United States, 13.4 percent of all brain and CNS tumors diagnosed in 2009 were located in the pituitary.

4 May 2010

Hologic commences enrollment in European trial of Gestiva for prevention of recurrent preterm birth

K-V Pharmaceutical Company announced today it has been informed by Hologic, Inc. that site initiation and patient enrollment has begun at international clinical trial sites in Europe in the ongoing trial of Gestiva™ (hydroxyprogesterone caproate injection, 250 mg/1 mL), commonly referred to as "17P," for the prevention of preterm birth in women pregnant with a single baby with a history of singleton spontaneous preterm birth.

From Hologic, Inc. 4 May 2010

Data from Phase IV study of Bystolic tablets in Hispanic patients with hypertension presented at ASH 2010

Forest Laboratories, Inc. today presented data from a Phase IV study evaluating the effects of Bystolic (nebivolol) tablets in Hispanic patients with hypertension at the 2010 annual scientific meeting of the American Society of Hypertension.

4 May 2010

Researchers present positive results of Phase II clinical trial of eliglustat tartrate

Gaucher disease, a rare enzyme deficiency disorder, is one of many conditions with few approved treatment options for patients. In a study published online today in Blood, the journal of the American Society of Hematology, researchers present positive results of a Phase II clinical trial of eliglustat tartrate, an oral therapy in development to treat Gaucher disease.

4 May 2010

Stratatech to advance living human skin substitute tissue clinical trial with $3M funding round

Stratatech Corp., a regenerative medicine company focused on the commercialization of cell-based, tissue-engineered skin substitute products, today announced that it has closed a $3.0-million round of funding comprised of convertible notes. The funding was secured from current investors in the company. The proceeds will be used to advance the clinical trial of the company's StrataGraft® living human skin substitute tissue. The company expects to begin Phase IIb of the trial during the second half of 2010.

4 May 2010

Array BioPharma reports 18.4M revenue for third-quarter fiscal 2010

Array BioPharma Inc. today reported financial results for the third quarter of fiscal 2010.

4 May 2010

Interim study results demonstrate anti-tumor activity of CytRx's INNO-206 in myeloma tumor cells

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced interim study results that showed its doxorubicin prodrug INNO-206 demonstrated statistically significant anti-tumor activity in human myeloma tumor cells growing in immune-deficient mice compared to a control group, while exhibiting significantly less toxicity than doxorubicin even though INNO-206 was administered at much higher doses.

3 May 2010

FDA approves Abbott's CREON sNDA including dosing guidance for treating EPI due to CP, pancreatectomy

Abbott announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for CREON® (pancrelipase) Delayed-Release Capsules that now includes dosing guidance in the prescribing information specific to patients with limited production of enzymes in the pancreas (exocrine pancreatic insufficiency) due to chronic pancreatitis (CP) or removal of the pancreas (pancreatectomy). Prior to this FDA approval, dosing guidance for medications such as CREON was based on patients with cystic fibrosis.

3 May 2010

AVANIR Pharmaceuticals reports net loss of $6.4 million for second-quarter fiscal 2010

AVANIR Pharmaceuticals, Inc. today reported unaudited financial results for the three and six months ended March 31, 2010.

3 May 2010

Raptor Pharmaceutical presents positive results from Phase 2a trial of DR cysteamine bitartrate for NASH

Raptor Pharmaceutical Corp., announced positive Phase 2a clinical trial results from its pilot study of delayed-release cysteamine bitartrate in 11 adolescent patients with non-alcoholic steatohepatitis, a progressive form of liver disease believed to affect 5% to 11% of the U.S. population. The results were presented at the Digestive Disease Week 2010 conference in New Orleans, LA on May 2, 2010.

3 May 2010

Belatacept preserves kidney function in transplant recipients better than cyclosporine, says study

Two-year results from phase III clinical trials show the experimental immunosuppressive drug belatacept can better preserve kidney function in kidney transplant recipients while preventing graft rejection when compared with the standard immunosuppressive drug cyclosporine.

3 May 2010

Conservative therapies recommended over routine use of OTC cough/cold products in children

Despite their widespread use by parents and caregivers, over-the-counter cold and cough medicines have carried a warning by the FDA since 2008, and still have the potential to cause serious adverse events in infants and children. Conservative therapies, including nasal suctioning, humidification, and nasal saline, should be recommended over routine use of OTC cough/cold products in infants and children, according to a new commentary published in the May 2010 issue of Otolaryngology - Head and Neck Surgery.

3 May 2010

Scripps Research Institute awarded grant to design assays for exploring potential target for obesity, Type 2 diabetes

The Scripps Research Institute has been awarded a $1.3 million grant by the National Institutes of Health (NIH) to develop a series of tests at its Florida campus to help explore the potential of a protein that has emerged as a highly attractive target for the treatment of obesity and Type 2 diabetes.

3 May 2010

Sistemic announces availability new SistemRNA Technology

Sistemic today announced immediate availability new SistemRNA product lines in key therapeutic areas including oncology and inflammation. These new product additions will strengthen strategic decision making at critical stages of the drug discovery and development process, helping to realise the full value of client's compound assets.

3 May 2010

Promising results from combination therapy of pemetrexed concurrent with radiation in lung cancer

The first trial of an important new combination therapy of treatment with the chemotherapy drug pemetrexed concurrent with radiation in lung cancer has delivered promising results, French researchers report at the 2nd European Lung Cancer Conference.

3 May 2010

AVANIR Pharmaceuticals announces filing of Complete Response to FDA Approvable Letter for Zenvia

AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the submission of its Complete Response to the October 2006 Approvable Letter issued by the U.S. Food and Drug Administration (FDA) for Zenvia™ (dextromethorphan/quinidine) for the treatment of pseudobulbar affect (PBA). AVANIR expects the FDA to classify the response as a Class 2 resubmission, which would result in an expected review period of 180 days and potential approval of Zenvia in the fourth calendar quarter of 2010.

3 May 2010

Probiotic supplementation helps ELBW infants gain weight: Study

Extremely low birthweight infants who received feedings supplemented with probiotics had better weight gain than infants who were not given the supplements, according to a randomized, controlled, double-blind study to be presented Saturday, May 1 at the Pediatric Academic Societies annual meeting in Vancouver, British Columbia, Canada.

3 May 2010

Preclinical safety data reports Natural S-equol has little effect on 2 reproductive hormones

Natural S-equol, a novel soy germ-based compound, is very likely the primary ingredient for reducing hot flushes in the dietary supplement SE5-OH, which is under development for reduction of menopause symptoms, according to pre-clinical efficacy data from studies using an animal model presented at the Experimental Biology 2010 annual meeting.

3 May 2010

SGB procedure holds potential promise for PTSD treatment

Walter Reed Army Medical Center in Bethesda, MD, has published case reports detailing the successful treatment of combat-related post-traumatic stress disorder with a stellate ganglion block.

3 May 2010

FDA approves continuation of Phase IIb clinical trial for superficial bladder cancer

Tikcro Technologies Ltd. today announced that BioCancell Therapeutics, Inc., concluded the first 18 patient group treated pursuant to a Phase IIb clinical trial of the drug candidate BC-819 for use in superficial bladder cancer. These patients had not responded to conventional treatment.

3 May 2010

Efficacy News and Research

Researchers evaluate efficacy of GKRS in patients with pituitary adenoma

Hologic commences enrollment in European trial of Gestiva for prevention of recurrent preterm birth

Data from Phase IV study of Bystolic tablets in Hispanic patients with hypertension presented at ASH 2010

Researchers present positive results of Phase II clinical trial of eliglustat tartrate

Stratatech to advance living human skin substitute tissue clinical trial with $3M funding round

Array BioPharma reports 18.4M revenue for third-quarter fiscal 2010

Interim study results demonstrate anti-tumor activity of CytRx's INNO-206 in myeloma tumor cells

FDA approves Abbott's CREON sNDA including dosing guidance for treating EPI due to CP, pancreatectomy

AVANIR Pharmaceuticals reports net loss of $6.4 million for second-quarter fiscal 2010

Raptor Pharmaceutical presents positive results from Phase 2a trial of DR cysteamine bitartrate for NASH

Belatacept preserves kidney function in transplant recipients better than cyclosporine, says study

Conservative therapies recommended over routine use of OTC cough/cold products in children

Scripps Research Institute awarded grant to design assays for exploring potential target for obesity, Type 2 diabetes

Sistemic announces availability new SistemRNA Technology

Promising results from combination therapy of pemetrexed concurrent with radiation in lung cancer

AVANIR Pharmaceuticals announces filing of Complete Response to FDA Approvable Letter for Zenvia

Probiotic supplementation helps ELBW infants gain weight: Study

Preclinical safety data reports Natural S-equol has little effect on 2 reproductive hormones

SGB procedure holds potential promise for PTSD treatment

FDA approves continuation of Phase IIb clinical trial for superficial bladder cancer

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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