Efficacy News and Research

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Oramed presents ORMD-0801 Phase IIb results for Type II diabetes at Annual Meeting in Bethesda

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, presented the results of its recently completed Phase IIb trial. The multicenter, placebo-controlled, randomized, double-blind study conducted in 29 patients with Type II diabetes assessed the safety of ORMD-0801 in patients with Type II diabetes.

16 Nov 2010

Teva presents QNAZE Phase III study results for SAR at ACAAI Meeting

Teva Pharmaceutical Industries Ltd. today announced results from a Phase III study of QNAZE (beclomethasone dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR), that demonstrated significantly greater symptom relief compared with placebo.

15 Nov 2010

Celladon’s Phase 2 CUPID trial shows improved clinical outcomes in advanced heart failure patients

Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, today announced that 12-month data from its Phase 2 CUPID clinical trial of MYDICAR demonstrated significant improvements in clinical outcomes and key disease markers in advanced heart failure patients treated with the genetically-targeted enzyme replacement therapy.

15 Nov 2010

High-dose prescription omega-3 does not reduce recurrence of atrial fibrillation

Although some data have suggested that omega-3 fatty acid supplements, such as from fish oil, may improve treatment of atrial fibrillation, a randomized trial with more than 600 patients finds that treatment with high-dose prescription omega-3 did not reduce the recurrence of atrial fibrillation over six months, according to a study that will appear in the December 1 issue of JAMA. The study is being released early online because it will be presented at the American Heart Association's annual meeting.

15 Nov 2010

Shire announces FDA approval of Vyvanse Capsules CII for ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved the prescription medication Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents ages 13 to 17. The approval is based on study data demonstrating that Vyvanse improved ADHD symptoms compared to placebo in adolescents with ADHD. Vyvanse is also indicated for the treatment of ADHD in children ages 6 to 12 years, and adults.

15 Nov 2010

No difference in risk of nonsuicide death between ziprasidone and olanzapine for schizophrenia

The potential for harmful side effects associated with anti-psychotic medications for treating schizophrenia is a frustration for mental-health professionals who must balance this with the positive benefits of drugs. For example, the issue of the antipsychotic drug ziprasidone lengthening the QTc interval, a possible indicator of life-threatening heart arrhythmias, has demanded much attention among clinicians since the drug was introduced in 2001.

15 Nov 2010

World's first remote heart procedure using robotic arm alongside 3-D mapping

The world's first remote heart procedure, using a robotic arm alongside 3-D mapping, is due to take place at Glenfield Hospital in Leicester.

15 Nov 2010

Science and precedent do not support biosimilar approach for plasma protein therapies

The current science and experience does not support the safety and efficaciousness of a biosimilar pathway for plasma protein therapies. At a public hearing last week, the Plasma Protein Therapeutics Association (PPTA) urged the United States Food and Drug Administration (FDA) to make patient safety its top priority by adopting a global approach in its evaluation of plasma protein therapies for the biosimilars process.

15 Nov 2010

Talecris announces publication of A1PI studies for AAT deficiency in Respiratory Research journal

Talecris Biotherapeutics announced today the publication of combined data from two studies demonstrating that augmentation therapy with Alpha(1)-Proteinase Inhibitor (Human) (A1PI) significantly reduces lung tissue loss in patients with emphysema related to Alpha(1)-antitrypsin (AAT) deficiency.

15 Nov 2010

Scios announces results of ASCEND-HF trial for ADHF treatment

Scios Inc. announced today that the landmark investigational study of NATRECOR (nesiritide) for the treatment of acutely decompensated heart failure (ADHF), ASCEND-HF, demonstrated no statistically significant difference from placebo in the co-primary endpoints of dyspnea, measured at six and 24 hours, or in the composite of heart failure re-hospitalizations and death during the first 30 days following treatment.

15 Nov 2010

Santarus announces commercial U.S. launch of CYCLOSET for type 2 diabetes mellitus

Santarus, Inc., a specialty biopharmaceutical company, today announced the commercial U.S. launch of CYCLOSET (bromocriptine mesylate) tablets. CYCLOSET is a prescription drug approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus both as monotherapy and in combination with other oral antidiabetic agents.

15 Nov 2010

Cerulean closes $24 million Series C financing by Lilly Ventures

Cerulean Pharma Inc., a leader in designing and developing nanopharmaceuticals, today announced that the Company has closed a $24 million Series C financing led by Lilly Ventures, with participation from all other existing investors including Polaris Venture Partners, Venrock, Lux Capital, and Bessemer Venture Partners.

15 Nov 2010

Oregon scientist investigates safety, effectiveness of novel low-cost family-planning option

The Bill & Melinda Gates Foundation has awarded nationally prominent Oregon Health & Science University reproductive scientist Jeffrey T. Jensen, M.D., M.P.H., a $100,000 grant to investigate the safety and effectiveness of a novel low-cost family-planning option that may be applicable to women in low-resource countries worldwide.

15 Nov 2010

Immunitor completes V5 Phase IIb imm01 clinical trial enrollment for TB

Immune Network Ltd., advises that its potential acquisition, Immunitor USA Inc., has announced the completion of enrollment in its Phase IIb imm01 clinical trial of V5 in tuberculosis.

15 Nov 2010

Dyax to present data of KALBITOR inhibitor for Angioedema at ACAAI Meeting

Dyax Corp. today announced that an abstract featuring KALBITOR (ecallantide) data was accepted for oral presentation at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting held November 11-16, at the Phoenix Convention Center in Phoenix, AZ. Two additional abstracts were selected as poster sessions.

15 Nov 2010

Derma Sciences net sales for third quarter 2010 increase 17% to $15,096,134

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today reported financial and operating results for the three and nine months ended September 30, 2010.

12 Nov 2010

Clinical trial results of Threshold's TH-302 hypoxia-activated prodrug presented at 16th CTOS annual meeting

Threshold Pharmaceuticals, Inc. today announced clinical trial results related to Threshold's clinical stage hypoxia-activated prodrug, TH-302. The results were presented at the 16th Annual Connective Tissue Oncology Society (CTOS) Meeting taking place in Paris, France from November 11 to 13, 2010.

12 Nov 2010

U-M researchers develop simple mathematical model to predict whooping cough transmission

Strategies for preventing the spread of whooping cough on the rise in the United States and several other countries in recent years should take into account how often people in different age groups interact, research at the University of Michigan suggests.

12 Nov 2010

SLIT immunotherapy effective for long-term remission of bothersome allergy symptoms

Antihistamines and nasal steroids offer good short-term options for people with mild allergy, but allergy immunotherapy, better known as "allergy shots," is a preferred method for achieving long term remission of more bothersome allergy symptoms. Allergists mark the 100th anniversary of immunotherapy and present the latest advances at the American College of Allergy, Asthma and Immunology (ACAAI) annual scientific meeting in Phoenix, Nov. 11-16.

12 Nov 2010

New report highlights effectiveness of bed rest for pregnant women

Despite lack of evidence about bed rest's effectiveness, doctors annually prescribe it for roughly 1 million pregnant women to delay preterm births. Judith Maloni, professor at the Frances Payne Bolton School of Nursing at Case Western Reserve University, said a comprehensive review of more than 70 evidence-based research articles challenges whether this is healthy for mothers or their babies.

12 Nov 2010

Efficacy News and Research

Oramed presents ORMD-0801 Phase IIb results for Type II diabetes at Annual Meeting in Bethesda

Teva presents QNAZE Phase III study results for SAR at ACAAI Meeting

Celladon’s Phase 2 CUPID trial shows improved clinical outcomes in advanced heart failure patients

High-dose prescription omega-3 does not reduce recurrence of atrial fibrillation

Shire announces FDA approval of Vyvanse Capsules CII for ADHD in adolescents

No difference in risk of nonsuicide death between ziprasidone and olanzapine for schizophrenia

World's first remote heart procedure using robotic arm alongside 3-D mapping

Science and precedent do not support biosimilar approach for plasma protein therapies

Talecris announces publication of A1PI studies for AAT deficiency in Respiratory Research journal

Scios announces results of ASCEND-HF trial for ADHF treatment

Santarus announces commercial U.S. launch of CYCLOSET for type 2 diabetes mellitus

Cerulean closes $24 million Series C financing by Lilly Ventures

Oregon scientist investigates safety, effectiveness of novel low-cost family-planning option

Immunitor completes V5 Phase IIb imm01 clinical trial enrollment for TB

Dyax to present data of KALBITOR inhibitor for Angioedema at ACAAI Meeting

Derma Sciences net sales for third quarter 2010 increase 17% to $15,096,134

Clinical trial results of Threshold's TH-302 hypoxia-activated prodrug presented at 16th CTOS annual meeting

U-M researchers develop simple mathematical model to predict whooping cough transmission

SLIT immunotherapy effective for long-term remission of bothersome allergy symptoms

New report highlights effectiveness of bed rest for pregnant women

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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