Efficacy News and Research

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Nonanesthesiologist-administered propofol for GI procedures safe

The worldwide safety experience of endoscopist-administered propofol sedation now exceeds 600,000 patients. The low rate of serious adverse events underscores the safety of nonanesthesiologist-administered propofol (NAAP) for gastrointestinal (GI) procedures, provided that it is administered by a team of individuals who have received training specific to the administration of propofol according to the "Position statement: nonanesthesiologist administration of propofol for GI endoscopy" issued by the four major gastroenterology and hepatology societies.

3 Dec 2009

MaRS teams up with Baycrest to develop and market brain fitness products

One of the world's leading cognitive science institutes announced today it has created a new company with MaRS, Canada's premiere innovation centre, to develop and market brain fitness products to help adults extend their memory and cognitive abilities longer in the lifespan.

3 Dec 2009

More than 80 abstracts highlighting Bristol-Myers Squibb's oncology compound to be presented

Bristol-Myers Squibb Company today announced that more than 80 abstracts highlighting compounds from the company’s oncology portfolio will be presented at the 51st Annual Meeting of the American Society of Hematology (ASH) to be held December 5-8 in New Orleans.

3 Dec 2009

European Phase III clinical trial of budesonide MMX completes patient enrollment

Santarus, Inc., a specialty biopharmaceutical company, today announced that its collaboration partner, Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA (SIX: COPN), has completed enrollment of 514 patients in the European Phase III clinical trial to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis.

3 Dec 2009

MIT scientists develop computer models to predict realistic drug delivery patterns from stents

MIT scientists including Elazer R. Edelman, the Thomas D. and Virginia W. Cabot Professor of Health Science and Technology (HST), and HST postdoctoral associate Vijaya B. Kolachalama, developed computer models to predict physiologically realistic drug delivery patterns from stents in branched arterial vessels.

2 Dec 2009

Javelin Pharmaceuticals submits an NDA for Dyloject Injection

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, for the management of acute moderate-to-severe pain in adults.

2 Dec 2009

Ellipse Technologies presents clinical results of its MAGEC System study

Ellipse Technologies, Inc. announced today that a scientific presentation of the pre-human clinical results of the MAGEC System were presented by Dr. Gregory Mundis at the 3rd International Congress on Early Onset Scoliosis and Growing Spine held in Istanbul, Turkey, November 20 and 21st.

2 Dec 2009

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

S*BIO to present data on its novel oral JAK2 inhibitor at The American Society of Hematology meeting

S*BIO Pte Ltd today announced data presentations on its novel oral JAK2 inhibitor, SB1518, at The American Society of Hematology 51st Annual Meeting and Exposition in New Orleans.

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

International AIDS Vaccine Initiative calls for redoubled efforts in vaccine development

As we approach World AIDS Day, observed globally December 1, we are reminded that while progress has been made in expanding access to treatment and prevention and that progress has been made toward the development of new prevention tools, the world is still falling short of established targets for providing universal access to HIV and AIDS prevention, treatment and care by 2010. Nearly 5.5 million of the estimated 9.5 million people in need of antiretroviral therapy are still not receiving it.

2 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

MagForce Nanotechnologies applies for EU regulatory approval of its Nano-Cancer therapy

MagForce Nanotechnologies AG, the Berlin-based medical nanotechnology company majority owned by Nanostart AG, has submitted its application for the European regulatory approval of its Nano-Cancer® therapy.

2 Dec 2009

nContact Surgical initiates clinical trials of its convergent procedure for paroxysmal AF

nContact Surgical, Inc. ("nContact"), a leader in the investigation of devices for minimally-invasive treatment for heart conditions, today announced the initiation of a feasibility clinical trial designed to evaluate the safety and efficacy of a combined surgical and catheter procedure, the convergent procedure, for the treatment of symptomatic paroxysmal atrial fibrillation (AF). This prospective, feasibility study will enroll patients at study sites across the United States.

2 Dec 2009

Development of novel virus can lead to new therapeutic strategy to combat cancer

Ohio State University cancer researchers have developed a tumor-attacking virus that both kills brain-tumor cells and blocks the growth of new tumor blood vessels.

2 Dec 2009

Bioactive sponge to eliminate normally fatal tumors

InCytu Incorporated, a therapeutic device engineering company, announced the details of its Cellarium™ Cancer Vaccine program. Cellarium™ is a small bioactive sponge which regulates dendritic cells and T-cells to eliminate normally fatal tumors in a preclinical model of late stage melanoma. The details of such a promising new vaccine were published for the first time in Science’s Translational Medicine Journal.

2 Dec 2009

Boehringer Ingelheim to announce positive results from its RE-COVER study

Boehringer Ingelheim will announce positive results from the landmark RE-COVER™ study at the 51st Annual Meeting of the American Society of Hematology on 6 December 2009. The RE-COVER™ study assessed dabigatran etexilate in a head-to-head comparison with the current standard in care, warfarin, for the treatment of acute venous thromboembolism (VTE), enabling healthcare professionals to make direct comparisons and care based value judgements.

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

Efficacy News and Research

Nonanesthesiologist-administered propofol for GI procedures safe

MaRS teams up with Baycrest to develop and market brain fitness products

More than 80 abstracts highlighting Bristol-Myers Squibb's oncology compound to be presented

European Phase III clinical trial of budesonide MMX completes patient enrollment

MIT scientists develop computer models to predict realistic drug delivery patterns from stents

Javelin Pharmaceuticals submits an NDA for Dyloject Injection

Ellipse Technologies presents clinical results of its MAGEC System study

FDA approves revised clinical trial protocol for CytRx' arimoclomol

S*BIO to present data on its novel oral JAK2 inhibitor at The American Society of Hematology meeting

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

International AIDS Vaccine Initiative calls for redoubled efforts in vaccine development

New data demonstrating the strength of Novartis' hematology portfolio to be presented

MagForce Nanotechnologies applies for EU regulatory approval of its Nano-Cancer therapy

nContact Surgical initiates clinical trials of its convergent procedure for paroxysmal AF

Development of novel virus can lead to new therapeutic strategy to combat cancer

Bioactive sponge to eliminate normally fatal tumors

Boehringer Ingelheim to announce positive results from its RE-COVER study

Results from second Phase III placebo controlled study of EXPAREL announced

J&JPRD submits an NDA for tapentadol ER tablets

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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