Clinical Trial News and Research

RSS

Insurance and risk management challenges in overseas clinical trials for U.S.-based life sciences companies

The ACE Group of insurance and reinsurance companies today announced the availability of an informational white paper focusing on insurance and risk management issues faced by life sciences companies as they conduct business in the U.S. and globally. The paper, “Managing the Complex Challenges of a Global Insurance Program: Foreign Clinical Trials Case Study,” appeared in the November issue of John Liner Review, and is part of ACE Progress ReportsSM, a collection of white papers, articles and executive reports on current and emerging risk management issues.

5 Mar 2010

Successful periodontal treatment reduces preterm birth risk

Previous studies have explored the effect of periodontal treatment, irrespective of efficacy of treatment, in reducing infant prematurity. In a study titled "Risk of Preterm Birth Is Reduced with Successful Periodontal Treatment," lead researcher M. Jeffcott, and colleagues S. Parry and M. Sammel (all from the University of Pennsylvania, Philadelphia) and G. Macones (Washington University, St. Louis, Missouri) determined whether a reduction in infant prematurity was associated with successful periodontal treatment.

5 Mar 2010

Data evaluating safety, efficacy of STELARA and REMICADE in patients with plaque psoriasis to be presented

Data evaluating the efficacy and safety of STELARA™ (ustekinumab) and REMICADE® (infliximab) in patients with plaque psoriasis who had an inadequate response to Enbrel® (etanercept) will be presented at the 68th Annual Meeting of the American Academy of Dermatology (AAD) in Miami, Fla., from March 5-9, 2010.

5 Mar 2010

BioClinica announces partnerships with Health Sciences International and PRL Central Laboratory Services

BioClinica™, Inc.,, a global provider of clinical trial management services, today announced it has created strategic partnerships with two clinical research organizations (CROs), Health Sciences International, Inc., and PRL Central Laboratory Services. Both alliances strengthen the BioClinica Certified Partner Program, a group of VIP CRO partners chosen based on therapeutic expertise and customer satisfaction.

From Clario 5 Mar 2010

Enigma Diagnostics opens new Regional HQ office in San Diego

Enigma Diagnostics Limited, the decentralised and point-of-care molecular diagnostics company, announced today the opening of its new Regional HQ office in San Diego, CA and the appointment of Joel Centeno as VP Regulatory & Quality.

4 Mar 2010

Micromet reports total revenues of $4.6M for three months ended December 31, 2009

Micromet, Inc., a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced its financial results for the fourth quarter and full year ended December 31, 2009. The Company also highlighted recent pipeline progress and outlined expected 2010 milestones.

4 Mar 2010

Inspire Pharmaceuticals reports net loss of $2.6 million for 2009 fourth quarter

Inspire Pharmaceuticals, Inc. announced today financial results for the fourth quarter and year ended December 31, 2009, reporting a net loss of $2.6 million or ($0.03) per share for the fourth quarter and a net loss of $40.0 million or ($0.60) per share for the full year.

4 Mar 2010

Childhood absence epilepsy: Comparative clinical trial of widely used anti-seizure drugs

The first comprehensive comparative effectiveness clinical trial of three widely used anti-seizure drugs for childhood absence epilepsy - the most common form of epilepsy in kids - has established an evidence-based approach for initial drug therapy.

4 Mar 2010

Phase III GOG-212 clinical trial of CTI's OPAXIO for ovarian cancer: Enrollment to continue

Cell Therapeutics, Inc. announced today that CTI received a statement on March 1, 2010 from the Gynecologic Oncology Group (GOG) leadership that the phase III GOG-212 clinical trial of CTI's OPAXIO™ used as maintenance therapy for ovarian cancer remains a high priority and enrollment will continue. The GOG made the statement to clarify that the recent results of the GOG-218 clinical trial bevacizumab in maintenance therapy for ovarian cancer has not influenced the importance of completing the GOG-212 clinical trial.

4 Mar 2010

Cryoablation kills breast tumors in mice

Freezing a cancer kills it in its place, and also appears to generate an immune response that helps stop the cancer's spread, leading to improved survival rates over surgery, according to a new study in mice from researchers at the University of Michigan Comprehensive Cancer Center.

4 Mar 2010

CureDuchenne: Scientific advisors to come together to find cure for DMD

Today, CureDuchenne, a nonprofit dedicated to raising funds and awareness for Duchenne Muscular Dystrophy (DMD), announced that on March 19, 2010 the organization’s scientific advisors from around the country will come together in the fight to find a cure for Duchenne Muscular Dystrophy.

4 Mar 2010

Gene therapy for LCA clears another hurdle: Study

Gene therapy for a severe inherited blindness, which produced dramatic improvements last year in 12 children and young adults who received the treatment in a clinical trial, has cleared another hurdle. The same research team that conducted the human trial now reports that a study in animals has shown that a second injection of genes into the opposite, previously untreated eye is safe and effective, with no signs of interference from unwanted immune reactions following the earlier injection.

4 Mar 2010

Endocyte's PRECEDENT study: DSMB recommends enrollment to continue

Endocyte, Inc., a biotech company developing guided therapeutics and diagnostics for personalized medicine, has announced that an independent data safety monitoring board (DSMB) recommended that enrollment into the PRECEDENT study continue.

4 Mar 2010

Study suggests vitamin D supplements may decrease insulin resistance, fight depression

A daily dose of vitamin D may just be what Chicagoans need to get through the long winter, according to researchers at Loyola University Chicago Marcella Niehoff School of Nursing (MNSON). This nutrient lifts mood during cold weather months when days are short and more time is spent indoors.

4 Mar 2010

Negative results from latrepirdine Phase III clinical trial: Alzheimer's Association disappointed

"The Alzheimer's Association is disappointed to learn of the negative results from the Phase III clinical trial of latrepirdine (Dimebon)," said William Thies, Ph.D., Alzheimer's Association Chief Medical and Scientific Officer. "People with Alzheimer's, their families and caregivers desperately need more and better treatment options for this devastating, fatal brain disease."

4 Mar 2010

Shock: Norepinephrine favored over dopamine

Physicians treating patients with shock should consider norepinephrine instead of dopamine as a tool for stabilizing blood pressure, according to an editorial in the March 4, 2010, issue of the New England Journal of Medicine (NEJM).

3 Mar 2010

CPEX Pharmaceuticals' fourth-quarter 2009 revenues up 23%

CPEX Pharmaceuticals, Inc. today reported financial results for the fourth quarter and year ended December 31, 2009. For the quarter CPEX reported revenues of $5.2 million and a net loss of $498,000. For the year CPEX reported revenues of $18.7 million and a net loss of $3.0 million.

3 Mar 2010

Spectral Diagnostics receives FDA IDE approval for Toraymyxin

BioMS Medical Corp. today reported that Spectral Diagnostics has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for Toraymyxin(TM). Spectral Diagnostics and BioMS have entered into a services agreement whereby BioMS will assist Spectral, as required, in its commercialization of Toraymyxin(TM), a therapeutic hemoperfusion device for the treatment of severe sepsis. This approval permits Spectral to initiate its planned pivotal trial for Toraymyxin(TM) in the United States.

3 Mar 2010

VUCCC files for patent protection: New treatment regimen for Type 1 insulin-dependent diabetes

VUCCC P/L is pleased to announce that it has filed for patent protection of its ground breaking new treatment regimen for Type 1 'insulin-dependent' diabetes, through the European Patent Office.

3 Mar 2010

YM BioSciences files Form 6K regarding certain nimotuzumab US patents

YM BioSciences Inc., announces that it filed a Form 6K describing that certain US patents for nimotuzumab licensed to YM's majority-owned Canadian subsidiary , CIMYM BioSciences Inc., have become subject to a lien in the United States, pursuant to a court order, to a third party.

3 Mar 2010

Clinical Trial News and Research

Insurance and risk management challenges in overseas clinical trials for U.S.-based life sciences companies

Successful periodontal treatment reduces preterm birth risk

Data evaluating safety, efficacy of STELARA and REMICADE in patients with plaque psoriasis to be presented

BioClinica announces partnerships with Health Sciences International and PRL Central Laboratory Services

Enigma Diagnostics opens new Regional HQ office in San Diego

Micromet reports total revenues of $4.6M for three months ended December 31, 2009

Inspire Pharmaceuticals reports net loss of $2.6 million for 2009 fourth quarter

Childhood absence epilepsy: Comparative clinical trial of widely used anti-seizure drugs

Phase III GOG-212 clinical trial of CTI's OPAXIO for ovarian cancer: Enrollment to continue

Cryoablation kills breast tumors in mice

CureDuchenne: Scientific advisors to come together to find cure for DMD

Gene therapy for LCA clears another hurdle: Study

Endocyte's PRECEDENT study: DSMB recommends enrollment to continue

Study suggests vitamin D supplements may decrease insulin resistance, fight depression

Negative results from latrepirdine Phase III clinical trial: Alzheimer's Association disappointed

Shock: Norepinephrine favored over dopamine

CPEX Pharmaceuticals' fourth-quarter 2009 revenues up 23%

Spectral Diagnostics receives FDA IDE approval for Toraymyxin

VUCCC files for patent protection: New treatment regimen for Type 1 insulin-dependent diabetes

YM BioSciences files Form 6K regarding certain nimotuzumab US patents

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

Latest Life Science News