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First patient dosed with rFVIIIFc in A-LONG trial

Biogen Idec and Swedish Orphan Biovitrum today announced that the first patient has been dosed with the companies' long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc) in a global registrational clinical trial. The study, called A-LONG, is an open-label, multicenter, Phase 2/3 study designed to evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc in previously-treated hemophilia A patients.

6 Dec 2010

Research highlighting treatment for pediatric SCD, malaria presented at ASH 2010

Red blood cells have the very important role of carrying oxygen from the lungs to the rest of the body; therefore, disorders that affect RBCs can have a significant impact on quality of life. Sickle cell disease and malaria are two common RBC diseases that affect a significant portion of the U.S. and global populations. Sickle cell disease, a genetic blood disorder that causes deformed and dysfunctional red blood cells, affects an estimated 70,000 to 100,000 Americans, while malaria affects approximately 1,500 Americans annually and 190 to 311 million people worldwide.

6 Dec 2010

Study provides evidence of acute, long-term safety of external TNS for epilepsy

External trigeminal nerve stimulation, a novel form of neurostimulation, is an emerging therapy for drug resistant epilepsy. The results of a pilot feasibility study on the safety and tolerability of external TNS and its effect on the heart and blood pressure were reported here today at the 64th American Epilepsy Society Annual Meeting.

6 Dec 2010

Study: REVLIMID and dexamethasone for high-risk smoldering multiple myeloma reduce risk of disease progression

Celgene International Sàrl (NASDAQ: CELG) announced that data evaluating combination therapy REVLIMID® (lenalidomide) and dexamethasone in patients with high-risk asymptomatic smoldering multiple myeloma were presented during the American Society of Hematology's annual meeting. The study reported REVLIMID and dexamethasone prolonged time to progression.

6 Dec 2010

New studies answer questions related to stem cell transplant procedures in treating hematologic malignancies

Results from four innovative studies help answer outstanding questions about stem cell transplant procedures in treating various hematologic malignancies. Research that will be presented today at the 52nd Annual Meeting of the American Society of Hematology reveals that there is no increase in overall cancer risk in people who donate stem cells and that the utilization of a double cord blood stem cell transplant is associated with better overall outcomes when used early in the treatment of acute leukemias.

6 Dec 2010

Lundbeck reports positive phase III study data of clobazam in treating seizures associated with LGS

Today, Lundbeck Inc. presented positive data from its pivotal phase III study to determine the efficacy and safety profiles of the investigational compound clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome.

6 Dec 2010

Positive initial clinical data of IMGN901 used in combination regimen for multiple myeloma presented at ASH Annual Meeting

ImmunoGen, Inc., a biotechnology company that develops antibody-based anticancer products, today announced the presentation of positive initial clinical data with the Company's IMGN901 anticancer compound when used as part of a standard combination regimen to treat relapsed multiple myeloma.

6 Dec 2010

Pharnext receives French approval for Pleodrug Phase II clinical trial in Charcot-Marie Tooth disease type 1A

Pharnext SAS, a biopharmaceutical company specializing in the development of innovative treatments for severe neurological diseases and other major unmet medical needs, today announced that the French Agency for Healthcare Product Safety (AFSSAPS) has authorized a Phase II clinical trial with the first drug (a Pleodrug™) generated by the company's Pleotherapy™ technology platform in patients suffering from Charcot-Marie Tooth disease type 1A (CMT1A.

4 Dec 2010

URMC's Cone Beam CT scanner studies presented at RSNA 2010

While questions persist about the best ways to detect breast cancer early, a CT imaging system developed at the University of Rochester Medical Center and first unveiled five years ago is in a better position today to enter the fray -- at least in a supporting role to conventional mammography.

4 Dec 2010

UBC receives $7M grant from Bill & Melinda Gates Foundation for PRE-EMPT Project

The University of British Columbia has received a $7 million grant from the Bill & Melinda Gates Foundation. UBC researchers working at the Child & Family Research Institute will test new strategies for the monitoring, prevention, and treatment of pre-eclampsia.

4 Dec 2010

Zometa improves OS, PFS in newly diagnosed multiple myeloma patients: Phase III study

A newly published study in the Lancet suggested that a first-line treatment regimen including Zometa (zoledronic acid) significantly improved overall survival and progression-free survival in newly diagnosed multiple myeloma patients compared with a regimen that included oral clodronate. The impact on survival was independent of the effect of Zometa on bone complications (also known as skeletal-related events or SREs).

4 Dec 2010

SuperGen to present SGI-110 data for MDS, AML at ASH annual meeting

SuperGen, Inc. today announced that a summary of preclinical efficacy, safety, and pharmacokinetics data of SGI-110 will be presented at the American Society of Hematology in Orlando on Saturday, December 4, 2010 at 5:30 pm ET.

3 Dec 2010

Loyola nurses honored

Loyola University Health System revenue specialist Judy Williams, RN, CEN, TNS, recently took on a nontraditional nursing role, which resulted in a significant cost savings for the organization. Williams oversees fiscal responsibility for the Emergency Department. In this position, she has identified opportunities to overcome billing obstacles through intradepartmental collaboration and nurse education on proper documentation for reimbursement.

3 Dec 2010

Prostate cancer imaging shows real-time tumor metabolism

A UCSF research collaboration with GE Healthcare has produced the first results in humans of a new technology that promises to rapidly assess the presence and aggressiveness of prostate tumors in real time, by imaging the tumor's metabolism.

3 Dec 2010

Cell Therapeutics submits pixantrone NDA application to treat non-Hodgkin's lymphoma

Cell Therapeutics, Inc. today announced that it has submitted a formal appeal to the Office of New Drugs in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research regarding the agency's decision from earlier this year on the pixantrone New Drug Application to treat relapsed/refractory aggressive non-Hodgkin's lymphoma.

3 Dec 2010

Doctors still prescribe higher-dose menopausal hormone therapy pills

Doctors across the country are still prescribing higher-dose menopausal hormone therapy pills, despite clinical evidence that low doses and skin patches work just as well and carry fewer health risks. That's what researchers at the Stanford University School of Medicine found in a study that will be published online Dec. 2 in Menopause: The Journal of the North American Menopause Society.

3 Dec 2010

MHRA issues notice of acceptance for BioMarin's BMN 673 for genetically-defined cancers

BioMarin Pharmaceutical Inc. today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has completed review of the Clinical Trial Application (CTA) and has issued a notice of acceptance for BMN 673 for genetically-defined cancers.

3 Dec 2010

FDA accepts to file PMA application for LightTouch Cervical Scanner

Guided Therapeutics, Inc. announced that it was notified by the U.S. Food and Drug Administration (FDA) that the company's premarket approval application (PMA) for the LightTouch Cervical Scanner, for patients at risk for cervical cancer, is suitable for filing.

3 Dec 2010

FDA accepts IND application to initiate human clinical trial to evaluate BNC

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) to begin human clinical trials and evaluate the safety and efficacy of the company's second product, bisnorcymserine (BNC).

3 Dec 2010

Sirnaomics cemented partnership with Chinese pharmaceutical to develop siRNA therapeutics

Sirnaomics, Inc. announced today that the company has cemented a partnership with a Chinese pharmaceutical company for development of its small interfering RNA (siRNA) therapeutic (STP705) for scarless wound healing.

3 Dec 2010

Clinical Trial News and Research

First patient dosed with rFVIIIFc in A-LONG trial

Research highlighting treatment for pediatric SCD, malaria presented at ASH 2010

Study provides evidence of acute, long-term safety of external TNS for epilepsy

Study: REVLIMID and dexamethasone for high-risk smoldering multiple myeloma reduce risk of disease progression

New studies answer questions related to stem cell transplant procedures in treating hematologic malignancies

Lundbeck reports positive phase III study data of clobazam in treating seizures associated with LGS

Positive initial clinical data of IMGN901 used in combination regimen for multiple myeloma presented at ASH Annual Meeting

Pharnext receives French approval for Pleodrug Phase II clinical trial in Charcot-Marie Tooth disease type 1A

URMC's Cone Beam CT scanner studies presented at RSNA 2010

UBC receives $7M grant from Bill & Melinda Gates Foundation for PRE-EMPT Project

Zometa improves OS, PFS in newly diagnosed multiple myeloma patients: Phase III study

SuperGen to present SGI-110 data for MDS, AML at ASH annual meeting

Loyola nurses honored

Prostate cancer imaging shows real-time tumor metabolism

Cell Therapeutics submits pixantrone NDA application to treat non-Hodgkin's lymphoma

Doctors still prescribe higher-dose menopausal hormone therapy pills

MHRA issues notice of acceptance for BioMarin's BMN 673 for genetically-defined cancers

FDA accepts to file PMA application for LightTouch Cervical Scanner

FDA accepts IND application to initiate human clinical trial to evaluate BNC

Sirnaomics cemented partnership with Chinese pharmaceutical to develop siRNA therapeutics

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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