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FDA approves revised clinical trial protocol for CytRx' arimoclomol

CytRx Corporation, a biopharmaceutical company, is permitted to re-enter the clinic with its orally administered molecular chaperone drug candidate arimoclomol as a therapeutic treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), following the U.S. Food and Drug Administration’s (FDA) acceptance of a revised clinical trial protocol.

2 Dec 2009

Favorable initial results from Novavax' 2009 H1N1 VLP pandemic influenza vaccine Phase II study

Novavax, Inc. today reported favorable initial results from the first stage of a two-stage pivotal Phase II study evaluating the safety and immunogenicity of the company's 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine. Novavax is conducting this study in collaboration with Avimex Laboratories of Mexico to support registration of the vaccine in Mexico and potentially other countries.

2 Dec 2009

Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

Sepracor Inc. today announced that clinical study data for STEDESA™ (eslicarbazepine acetate) will be presented at the 2009 annual meeting of the American Epilepsy Society (AES) in Boston. Seven posters describing new safety analyses will be presented at the Hynes Convention Center during the formal poster session on Saturday, December 5, 2009 between 1:00 pm and 8:00 pm EST.

2 Dec 2009

Positive results from DermaGen's Phase I/IIa AMP study of atopic dermatitis

DermaGen AB - part of the Karolinska Development dermatology and wound healing company "Pergamum" - announced that Dermagen AB has received promising results from a clinical Phase I/IIa study. DermaGen AB is developing a novel antimicrobial peptide (AMP) treatment for atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin disease where dry skin and the skin's weakened barrier function make patients susceptible to colonization by microorganisms, a triggering or exacerbating factor of the disease.

2 Dec 2009

Pycnogenol can improve microcirculation, retinal edema and visual acuity, reveals study

According to the National Institute of Health, 40 percent to 45 percent of Americans diagnosed with diabetes already have some stage of diabetic retinopathy.

2 Dec 2009

New study indicates pine bark may reduce progressing advanced stages of diabetic retinopathy

According to the National Institute of Health, 40 percent to 45 percent of Americans diagnosed with diabetes already have some stage of diabetic retinopathy. Diabetic retinopathy, damage to the retina caused by leaky blood vessels, is a major cause of blindness in people with diabetes and is one of the most feared diabetic complications. In

2 Dec 2009

Roche announces results of phase III taspoglutide study in diabetes patients

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed the results of the second and third of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s research and developed by Roche.

2 Dec 2009

Results from second Phase III placebo controlled study of EXPAREL announced

Pacira Pharmaceuticals, Inc., announced today that its second Phase III placebo controlled study of EXPAREL(TM) (DepoBupivacaine) met its primary endpoint.

2 Dec 2009

J&JPRD submits an NDA for tapentadol ER tablets

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol extended release (ER) tablets, an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older.

2 Dec 2009

OptiNose announces study results of intranasal device for treating chronic rhinosinusitis with nasal polyps

OptiNose is pleased to announce the publication of results from its Phase II clinical study investigating the efficacy and tolerability of its novel, intranasal drug/device product for the topical treatment of chronic rhinosinusitis with nasal polyps in Rhinology, the official journal of the International and European Rhinologic Societies.

2 Dec 2009

Teva Pharmaceutical Industries submits a BLA for its G-CSF XM02

Teva Pharmaceutical Industries Ltd., today announced the submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

1 Dec 2009

Positive results from Ardea Biosciences' ongoing drug-drug interaction study of RDEA594 and febuxostat

Ardea Biosciences, Inc. announced positive results from the first dosing group of an ongoing drug-drug interaction and pharmacodynamic study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, and febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen). This

1 Dec 2009

Amgen to present updated data on Nplate at the 2009 ASH meeting

Amgen Inc. today announced that it will present updated long-term safety and efficacy data for Nplate® (romiplostim) in adult chronic immune (idiopathic) thrombocytopenic purpura (ITP). Additionally, Amgen will present the first Nplate study in a pediatric setting as well as in patients with myelodysplastic syndromes (MDS) at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition (Dec. 5 - 8, 2009).

1 Dec 2009

Phase 1 study of preventive HIV vaccine testing a novel delivery mechanism completed

A Phase 1 study of a preventive HIV vaccine testing a novel delivery mechanism known as electroporation – the use of electrical pulses to increase the immune responses elicited by DNA vaccines – was recently completed in New York City.

1 Dec 2009

USPTO issues Notice of Allowance for Titan Pharmaceuticals' Probuphine patent application

Titan Pharmaceuticals, Inc today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Titan’s United States patent application directed to the use of Probuphine for the treatment of opiate addiction.

1 Dec 2009

Eli Lilly's Cymbalta receives FDA approval

The U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults, announced Eli Lilly and Company (NYSE: LLY).

30 Nov 2009

Spectrum Pharmaceuticals completes enrollment in apaziquone Phase 3 trial

Spectrum Pharmaceuticals today announced that one of the two Phase 3 pivotal clinical trials of apaziquone has achieved its enrollment target, having enrolled approximately 800 patients with non-invasive bladder cancer. The second Phase 3 clinical trial of apaziquone is expected to complete enrollment by the end of the year.

30 Nov 2009

Study on placebo effect

A short time ago, Swedish scientists published a paper suggesting the existence of a genetic disposition to respond to placebo, thus giving rise to debate in the media about a possible "placebo gene." In the current issue of Deutsches Ärzteblatt International (Dtsch Arztebl Int 2009; 106[46]: 751-5), Matthias Breidert and Karl Hofbauer summarize the most recent data about placebos.

28 Nov 2009

European Commission approves MICARDIS medication for CV protection

MICARDIS® is the first treatment in its class to be approved for this indication. The EMEA approval is the second major milestone for MICARDIS® in cardiovascular protection. It follows the approval by the US FDA for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors.

27 Nov 2009

Merck to commence MK-6913 phase IIa efficacy trial for treatment of hot flashes/hot flushes

The Swedish biotech company Karo Bio today announced that Merck & Co., Inc., through an affiliate, plans to enter a clinical phase IIa trial with the collaboration's lead investigational drug candidate, MK-6913, identified as part of their joint research collaboration. No milestone payment to Karo Bio is associated with the initiation of phase II clinical development.

26 Nov 2009

Placebo News and Research

FDA approves revised clinical trial protocol for CytRx' arimoclomol

Favorable initial results from Novavax' 2009 H1N1 VLP pandemic influenza vaccine Phase II study

Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

Positive results from DermaGen's Phase I/IIa AMP study of atopic dermatitis

Pycnogenol can improve microcirculation, retinal edema and visual acuity, reveals study

New study indicates pine bark may reduce progressing advanced stages of diabetic retinopathy

Roche announces results of phase III taspoglutide study in diabetes patients

Results from second Phase III placebo controlled study of EXPAREL announced

J&JPRD submits an NDA for tapentadol ER tablets

OptiNose announces study results of intranasal device for treating chronic rhinosinusitis with nasal polyps

Teva Pharmaceutical Industries submits a BLA for its G-CSF XM02

Positive results from Ardea Biosciences' ongoing drug-drug interaction study of RDEA594 and febuxostat

Amgen to present updated data on Nplate at the 2009 ASH meeting

Phase 1 study of preventive HIV vaccine testing a novel delivery mechanism completed

USPTO issues Notice of Allowance for Titan Pharmaceuticals' Probuphine patent application

Eli Lilly's Cymbalta receives FDA approval

Spectrum Pharmaceuticals completes enrollment in apaziquone Phase 3 trial

Study on placebo effect

European Commission approves MICARDIS medication for CV protection

Merck to commence MK-6913 phase IIa efficacy trial for treatment of hot flashes/hot flushes

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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