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Positive topline results from ZGN-433 Phase 1b study in obesity patients

Zafgen, a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced positive topline results from its Phase 1b study of ZGN-433, a methionine aminopeptidase 2 inhibitor, for the treatment of severe obesity.

6 Jan 2011

Pico-Tesla commences placebo-controlled Magneceutical Therapy study for Alzheimer's disease

Pico-Tesla, The Magneceutical Company, announced that it has commenced a randomized, double-blind, placebo-controlled pilot study of 30 patients who have Alzheimer's disease symptoms.

6 Jan 2011

Study: Antibiotics can provide long-lasting relief to patients with irritable bowel syndrome

A ground-breaking antibiotic therapy developed at Cedars-Sinai Medical Center is the first potential drug treatment to provide irritable bowel syndrome patients with long-lasting relief of their symptoms even after they stop taking the medication, according to a study published in the Jan. 6 issue of the New England Journal of Medicine.

6 Jan 2011

FDA grants additional marketing exclusivity to INOMAX for pediatric BPD treatment

Ikaria, Inc. today announced that the U.S. Food and Drug Administration has granted INOMAX for inhalation an additional six months of marketing exclusivity, known as "pediatric exclusivity."

6 Jan 2011

DARA BioSciences provides additional details of DB959 Phase I study for Type 2 Diabetes

DARA BioSciences, provided additional details from the recently completed Phase I clinical study for DB959, its PPAR delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes.

6 Jan 2011

Bright light therapy for the aged depressed: Study

A new study shows that exposure to bright light may ease symptoms of depression in elderly people. The researchers tried three weeks of bright light therapy using specially designed light boxes and saw that it improved symptoms of depression by as much as 54% in older adults with depression. The light therapy also improved sleep and optimized levels of the neurotransmitter serotonin. Low levels of serotonin are associated with depression and often targeted by antidepressant drugs. This is the first study of its kind to show a beneficial effect of bright light therapy on treating depression in the elderly with non-seasonal major depressive disorder.

5 Jan 2011

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Celgene International Sàrl announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

5 Jan 2011

Betulin in birch bark appears to provide metabolic benefits

An ingredient found in abundance in birch bark appears to have an array of metabolic benefits, according to new studies in animals that are reported in the January issue of Cell Metabolism, a Cell Press publication.

5 Jan 2011

Blocking activation of delta-PKC enzyme could protect lungs from neutrophil-mediated damage

All of us may be able to breathe a little easier now that scientists from Pennsylvania have found a new therapeutic target for controlling dangerous inflammation in the lungs. A new research report in the January 2011 issue of the Journal of Leukocyte Biology (http://www.jleukbio.org) suggests that blocking the activation of an enzyme called delta-protein kinase C (delta-PKC) could protect the lungs from neutrophil-mediated damage, which can result in out of control inflammation.

5 Jan 2011

Spectrum submits FUSILEV sNDA for treatment of colorectal cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection.

5 Jan 2011

FDA lifts clinical hold on Hemispherx's Alferon LDO Phase II study for influenza prevention

Hemispherx Biopharma, Inc. announced today that the Food and Drug Administration (FDA) has lifted a clinical hold on its Phase II, double-blind, adaptive-design, randomized, placebo-controlled, dose-ranging study of Alferon® LDO [oral interferon alfa-n3 (human leukocyte derived)] for the prevention and treatment of influenza.

5 Jan 2011

Anadys begins ANA598 Phase IIb study for hepatitis C

Anadys Pharmaceuticals, Inc. announced today that it has initiated the planned Phase IIb study of ANA598 in combination with pegylated interferon and ribavirin. The protocol for the study has been cleared by the United States Food and Drug Administration and Health Canada.

4 Jan 2011

FDA approves ImmunoCellular Therapeutics IND amendment for ICT-107 Phase II clinical trial

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune-based therapies for the treatment of various forms of cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) amendment to conduct a Phase II clinical trial in the U.S. of ICT-107, the company's dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM).

4 Jan 2011

Bupropion and varenicline help curb cigarette craving

The smoking cessation medications bupropion and varenicline may both be associated with changes in the way the brain reacts to smoking cues, making it easier for patients to resist cravings, according to two reports posted online today that will appear in the May print issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

4 Jan 2011

Chest: January news briefs

New research suggests that subcutaneous omalizumab is safe and effective an add-on treatment to corticosteroids for moderate to severe asthma in children and adults. Researchers from Uruguay, Argentina, and Chile performed a meta-analysis on eight trials where 1,883 patients received omalizumab and 1,546 received a placebo.

4 Jan 2011

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

Repros Therapeutics Inc. today reported it has received Institutional Review Board (IRB) approval to commence the Phase IIb study of Androxal® in men with secondary hypogonadism. The Company has submitted the protocol for FDA comment and plans to begin enrolling subjects in January. Depending on the rate of subject enrollment, Repros hopes to have the study completed before the end of 2011.

3 Jan 2011

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

Juventas Therapeutics, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular disease, announces that the U.S. Food and Drug Administration (FDA) authorized commencement of a Phase II clinical trial evaluating the efficacy and safety of its lead product, JVS-100, for the treatment of critical limb ischemia (CLI).

3 Jan 2011

FDA approves 200 mg formulation of INTELENCE for HIV-1

The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

3 Jan 2011

Celera seeks FDA premarketing approval for KIF6 Genotyping Assay

Celera Corporation today announced that it has submitted a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for its KIF6 Genotyping Assay, a new molecular In Vitro diagnostic (IVD) test designed to detect a marker for risk of coronary heart disease (CHD) independent of traditional risk factors and aid clinical evaluation when statin treatment is being considered.

3 Jan 2011

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Inspire Pharmaceuticals, Inc. announced today the top-line results from its second Phase 3 clinical trial, TIGER-2, with denufosol tetrasodium for the treatment of cystic fibrosis.

3 Jan 2011

Placebo News and Research

Positive topline results from ZGN-433 Phase 1b study in obesity patients

Pico-Tesla commences placebo-controlled Magneceutical Therapy study for Alzheimer's disease

Study: Antibiotics can provide long-lasting relief to patients with irritable bowel syndrome

FDA grants additional marketing exclusivity to INOMAX for pediatric BPD treatment

DARA BioSciences provides additional details of DB959 Phase I study for Type 2 Diabetes

Bright light therapy for the aged depressed: Study

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Betulin in birch bark appears to provide metabolic benefits

Blocking activation of delta-PKC enzyme could protect lungs from neutrophil-mediated damage

Spectrum submits FUSILEV sNDA for treatment of colorectal cancer

FDA lifts clinical hold on Hemispherx's Alferon LDO Phase II study for influenza prevention

Anadys begins ANA598 Phase IIb study for hepatitis C

FDA approves ImmunoCellular Therapeutics IND amendment for ICT-107 Phase II clinical trial

Bupropion and varenicline help curb cigarette craving

Chest: January news briefs

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

FDA approves 200 mg formulation of INTELENCE for HIV-1

Celera seeks FDA premarketing approval for KIF6 Genotyping Assay

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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