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Biogen Idec, Sangamo BioSciences partner to develop therapeutics for hemoglobinopathies

Biogen Idec and Sangamo BioSciences, Inc. announced today an exclusive worldwide collaboration and license agreement focused on the development of therapeutics for hemoglobinopathies, inherited conditions that result from the abnormal structure or underproduction of hemoglobin.

9 Jan 2014

Merck announces FDA approval of ISENTRESS for oral suspension

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration recently approved ISENTRESS for oral suspension, a new pediatric formulation of Merck's integrase inhibitor. With this approval, ISENTRESS is now indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients four weeks of age and older.

9 Jan 2014

Proteon's PRT-201 gets orphan drug designation for prevention of arteriovenous access dysfunction

Proteon Therapeutics, Inc., a privately held biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases, today announced that its lead product, PRT-201, has received orphan drug designation in the European Union for the prevention of arteriovenous access dysfunction in hemodialysis patients.

9 Jan 2014

C. parvum and cryptosporidiosis: an interview with Dr. Momar Ndao, McGill University

Cryptosporidium parvum is one of the most common enteropathogens to affect humans in the world. The protozoan parasite causes a gut infection referred to as cryptosporidiosis.

8 Jan 2014

Emmaus completes all patient visits for Phase 3 trial of L-glutamine for treatment of sickle cell disease

Emmaus Medical, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of innovative and cost-effective treatments and therapies primarily for rare and orphan diseases, today announced it has completed all patient visits for its Phase 3 clinical trial for the treatment of sickle cell disease. Emmaus expects top-line data from the Phase 3 clinical trial to be available in the first quarter of 2014.

8 Jan 2014

OxThera announces initiation of Oxabact clinical study in Primary Hyperoxaluria

OxThera AB, a Stockholm-based privately-held biopharmaceutical company, today announced that it has initiated a clinical study in Primary Hyperoxaluria. This announcement bolsters the Company's position as a leader in developing therapies for hyperoxaluria, a debilitating condition that, if untreated, leads to kidney damage and end-stage renal disease.

8 Jan 2014

Study: Combined medications may improve smoking cessation than single drug therapy

Among cigarette smokers, combining the smoking cessation medications varenicline and bupropion, compared with varenicline alone, resulted in higher smoking abstinence rates for one outcome but not the other at three and six months; rates were similar at one year, according to a Mayo Clinic study published this month in JAMA.

8 Jan 2014

IQWiG study finds no added benefit of teriflunomide

Teriflunomide (trade name: Aubagio) has been approved in Germany since August 2013 for adults with relapsing remitting multiple sclerosis. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products, the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA).

8 Jan 2014

CytoDyn receives FDA approval to start Phase 2b study of PRO 140 for treatment of HIV-1

CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today the Company has received approval from the United States Food and Drug Administration (FDA) to commence patient screening of a Phase 2b study of PRO 140, a monoclonal CCR5 antibody, for the treatment of patients with Human Immunodeficiency Virus Type 1.

8 Jan 2014

FDA accepts NPS Pharmaceuticals' Natpara BLA for review

NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the U.S. Food and Drug Administration has accepted and filed for review the company's Biologics License Application for Natpara (recombinant human parathyroid hormone 1-84, (rhPTH[1-84])) for the treatment of hypoparathyroidism.

7 Jan 2014

Barostim Therapy: A cost-effective treatment for patients with drug resistant hypertension

CVRx, Inc., a privately held medical device company, today announced findings from a health-economic analysis published in the Journal of Hypertension that indicates Barostim Therapy is a cost-effective treatment option for patients with drug resistant hypertension.

7 Jan 2014

Oxygen Biotherapeutics announces publication of Phase 3 trial protocol for levosimendan

Oxygen Biotherapeutics, Inc. ("OBI") a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that the protocol of their phase 3 trial for levosimendan has been published on ClinicalTrials.gov, "Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Heart Surgery on Cardiopulmonary Bypass."

7 Jan 2014

Shield Therapeutics reports positive top-line data from pivotal Phase 3 programme of ST10

Shield Therapeutics, an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces strongly positive top-line data from the pivotal Phase 3 programme of ST10 for the treatment of iron deficiency anaemia in inflammatory bowel disease.

7 Jan 2014

Research: Daily meditation may improve symptoms of anxiety and depression

Some 30 minutes of meditation daily may improve symptoms of anxiety and depression, a new Johns Hopkins analysis of previously published research suggests.

7 Jan 2014

Cerenis' Phase IIb CHI-SQUARE study fails to meet primary endpoint in post-ACS patients

Cerenis Therapeutics, the biopharmaceutical company, today announced that its Phase IIb CHI-SQUARE (Can HDL Infusions Significantly Quicken Atherosclerosis REgression?) study did not reach its primary endpoint in post-Acute Coronary Syndrome patients.

2 Jan 2014

Amgen announces romosozumab Phase 2 trial results in postmenopausal women with low BMD

Amgen and UCB (Euronext Brussels:UCB) today announced results from a Phase 2 trial evaluating romosozumab (AMG 785/CDP7851) in postmenopausal women with low bone mineral density (BMD).

2 Jan 2014

Study: Alpha tocepherol, fat-soluble vitamin E, antioxidant may slow functional decline in AD patients

Difficulty with activities of daily living often affect Alzheimer's patients, which is estimated to affect as many as 5.1 million Americans. These issues are among the most taxing burdens of the disease for caregivers, which total about 5.4 million family members and friends.

1 Jan 2014

Binge drinking during pregnancy can lead to fetal alcohol syndrome

Recent data shows that more than 500,000 women in the U.S. report drinking during pregnancy, with about 20 percent of this population admitting to binge drinking.

31 Dec 2013

CF101 drug fails to meet primary efficacy endpoint in phase III study for Dry Eye Syndrome

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that its subsidiary OphthaliX Inc. released results from a 24 week, placebo-controlled phase III study involving 237 patients with moderate-to-severe Dry Eye Syndrome who were treated with its licensed drug CF101, an A3 adenosine receptor agonist.

30 Dec 2013

Genzyme gets FDA Complete Response Letter for Lemtrada sBLA

Genzyme, a Sanofi company, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

30 Dec 2013

Placebo News and Research

Biogen Idec, Sangamo BioSciences partner to develop therapeutics for hemoglobinopathies

Merck announces FDA approval of ISENTRESS for oral suspension

Proteon's PRT-201 gets orphan drug designation for prevention of arteriovenous access dysfunction

C. parvum and cryptosporidiosis: an interview with Dr. Momar Ndao, McGill University

Emmaus completes all patient visits for Phase 3 trial of L-glutamine for treatment of sickle cell disease

OxThera announces initiation of Oxabact clinical study in Primary Hyperoxaluria

Study: Combined medications may improve smoking cessation than single drug therapy

IQWiG study finds no added benefit of teriflunomide

CytoDyn receives FDA approval to start Phase 2b study of PRO 140 for treatment of HIV-1

FDA accepts NPS Pharmaceuticals' Natpara BLA for review

Barostim Therapy: A cost-effective treatment for patients with drug resistant hypertension

Oxygen Biotherapeutics announces publication of Phase 3 trial protocol for levosimendan

Shield Therapeutics reports positive top-line data from pivotal Phase 3 programme of ST10

Research: Daily meditation may improve symptoms of anxiety and depression

Cerenis' Phase IIb CHI-SQUARE study fails to meet primary endpoint in post-ACS patients

Amgen announces romosozumab Phase 2 trial results in postmenopausal women with low BMD

Study: Alpha tocepherol, fat-soluble vitamin E, antioxidant may slow functional decline in AD patients

Binge drinking during pregnancy can lead to fetal alcohol syndrome

CF101 drug fails to meet primary efficacy endpoint in phase III study for Dry Eye Syndrome

Genzyme gets FDA Complete Response Letter for Lemtrada sBLA

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