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Rapid approvals for medical devices by FDA leads to increased recalls: Study

According to a latest study many medical devices recalled in recent years by the Food and Drug Administration (FDA) because they posed a high risk to patients were not rigorously studied before being approved for patient use. The study, appearing on the web site of The Archives of Internal Medicine, said that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway with little testing. This included external heart defibrillators, hospital infusion pumps and mechanical ventilators.

14 Feb 2011

U-Systems completes pivotal study for automated breast ultrasound cancer screening

U-Systems, the leader in automated breast ultrasound today announced the completion of a pivotal ROC Reader Study for automated breast ultrasound cancer screening. Conducted by University of Chicago, an acclaimed pioneer in women's heath research, the multi-reader, multi-case (MRMC) ROC Reader Study was carried-out to evaluate the sensitivity of somo•v™ Automated Breast Ultrasound (ABUS) together with a screening mammogram in detecting breast cancer in women with dense breast tissue.

14 Feb 2011

Elsevier / MEDai launch new version of Pinpoint Review clinical surveillance system for hospitals

Elsevier / MEDai, a leading provider of advanced clinical analytic healthcare solutions, announced today the launch of the latest version of Pinpoint Review(R), its real-time, clinical surveillance system for hospitals. The new version will feature an expanded set of clinical watch triggers, expanded core measure alerts and three new predictions: ICU Admission Prediction, Length of Stay Prediction and Mortality Prediction.

14 Feb 2011

Tianyin Pharmaceutical's second quarter revenue increases 69.6% to $25.3 million

Tianyin Pharmaceutical Co., Inc., a pharmaceutical company that specializes in the patented biopharmaceutical, modernized traditional Chinese medicine, branded generics and other pharmaceuticals, announced the financial results for the second quarter of Fiscal Year 2011.

14 Feb 2011

AP: Crooks find Medicare Part D an easy target

Crooks are taking advantage of lax oversight in Medicare's Part D prescription drug program to obtain highly addictive drugs including oxycodone, Ritalin, and methadone, according to results of a federal probe.

14 Feb 2011

BioTime to merge Glycosan with OrthoCyte

BioTime, Inc., a biotechnology company that develops and markets products in the field of stem cells and regenerative medicine, today announced it has signed a definitive agreement to merge Utah-based Glycosan BioSystems, Inc. (Glycosan) with BioTime's wholly-owned subsidiary, OrthoCyte Corporation. The acquisition is expected to close by March 18, 2011.

14 Feb 2011

Questcor's pricing issue

After Questcor Pharmaceuticals raised the price of the drug Acthar, its sole product, more than 10-fold in 2007, its shares began a climb from pennies to $14 and change. Acthar

14 Feb 2011

IMRIS fourth quarter sales increase 26% to $25.2 million

IMRIS Inc. today reported its results for the fourth quarter 2010 highlighted by record financial performance that included strong revenue growth and the Company's second consecutive quarter of positive EBITDA1 and earnings. All figures are reported in Canadian dollars.

14 Feb 2011

Best Practices publishes new report on 'Innovations in Patient-Focused Initiatives'

For the biopharmaceutical industry, the changing healthcare marketplace has increased the importance - and difficulty - of interacting with patients to improve outcomes. New technologies and access restrictions have created both opportunities and challenges for approaching and engaging patient populations to improve disease control.

14 Feb 2011

OXiGENE, NCI/CTEP and GOG collaborate on ZYBRESTAT Phase 2 study in relapsed ovarian cancer

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it has entered into a Cooperative Research and Development Agreement with the National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP) to collaborate on the conduct of a randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in patients with relapsed ovarian cancer.

14 Feb 2011

NHGRI's new strategic plan to identify genetic bases of most single-gene disorders

A new strategic plan from an arm of the National Institutes of Health envisions scientists being able to identify genetic bases of most single-gene disorders and gaining new insights into multi-gene disorders in the next decade. This should lead to more accurate diagnoses, new drug targets and the development of practical treatments for many who today lack therapeutic options, according to the plan from the National Human Genome Research Institute (NHGRI).

14 Feb 2011

First Edition: February 14, 2011

Today's headlines are focused on President Obama's budget proposal and what it does and does not include.

14 Feb 2011

Public-sector research has had an immediate effect on improving public health: Study

AUTM President Ashley Stevens, D. Phil. (Oxon), CLP is the lead author of The Role of Public Sector Research in the Discovery of Drugs and Vaccines, a paper published in the Feb. 10 issue of The New England Journal of Medicine.

14 Feb 2011

Numira acquires Ricerca' Efficacy Pharmacology operating unit

Numira Biosciences, a specialty contract research organization and leader in high resolution, 3D imaging services and visualization software for the life science market, announced today that it has acquired the Efficacy Pharmacology operating unit of Ricerca Biosciences, LLC., located in Bothell, WA.

14 Feb 2011

Vitamin D levels not linked to prostate cancer development

Vitamin D levels do not affect men's chances of developing prostate cancer, according to new research published in the journal Cancer Causes and Control.

14 Feb 2011

FDA accepts King's ACUROX NDA for filing with Priority review classification

Acura Pharmaceuticals, Inc. today announced that it has been informed by King Pharmaceuticals Research and Development Inc. (King) that King's New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets was accepted for filing by the US Food and Drug Administration (FDA) with a Priority review classification and a Prescription Drug User Fee Act (PDUFA) date of June 17, 2011.

14 Feb 2011

Registration open for idiopathic pulmonary fibrosis healthcare summit

The Pulmonary Fibrosis Foundation (PFF) announced today that registration is now open for the IPF Summit 2011: From Bench to Bedside. The conference will feature an innovative two-day continuing medical education (CME) program for physicians, researchers, and other health care professionals. Additionally there will be a separate one-day patient, family member, and caregiver program to address the growing educational needs of the idiopathic pulmonary fibrosis (IPF) community.

14 Feb 2011

New checklists to help providers use lowest dose necessary to perform fluoroscopic procedures on children

The Image Gently campaign has developed easily accessible online teaching materials and checklists to help providers use the lowest dose necessary to perform fluoroscopic procedures on children. Physicians, medical physicists, and radiologic technologists are encouraged to visit the Image Gently Web site (www.imagegently.org) to review these important materials and factor the information into their clinical decision making.

14 Feb 2011

Free, confidential home-kit testing for sexually transmitted infections effective with young people

Infectious disease experts at Johns Hopkins say new research clearly shows that screening teens and young adults for sexually transmitted infections may best be achieved by making free, confidential home-kit testing available over the Internet. From a public health standpoint, the project is a clear winner, the experts say.

14 Feb 2011

Less than one-third of acute stroke patients receive clot-busting drug within 60 minutes of hospital arrival

Every minute counts after the onset of a stroke. The more time that elapses before a patient receives an intravenous drug to help break up the clot that is blocking a blood vessel in the brain, the slimmer the chances of a good outcome.

14 Feb 2011

Research News and Research

Rapid approvals for medical devices by FDA leads to increased recalls: Study

U-Systems completes pivotal study for automated breast ultrasound cancer screening

Elsevier / MEDai launch new version of Pinpoint Review clinical surveillance system for hospitals

Tianyin Pharmaceutical's second quarter revenue increases 69.6% to $25.3 million

AP: Crooks find Medicare Part D an easy target

BioTime to merge Glycosan with OrthoCyte

Questcor's pricing issue

IMRIS fourth quarter sales increase 26% to $25.2 million

Best Practices publishes new report on 'Innovations in Patient-Focused Initiatives'

OXiGENE, NCI/CTEP and GOG collaborate on ZYBRESTAT Phase 2 study in relapsed ovarian cancer

NHGRI's new strategic plan to identify genetic bases of most single-gene disorders

First Edition: February 14, 2011

Public-sector research has had an immediate effect on improving public health: Study

Numira acquires Ricerca' Efficacy Pharmacology operating unit

Vitamin D levels not linked to prostate cancer development

FDA accepts King's ACUROX NDA for filing with Priority review classification

Registration open for idiopathic pulmonary fibrosis healthcare summit

New checklists to help providers use lowest dose necessary to perform fluoroscopic procedures on children

Free, confidential home-kit testing for sexually transmitted infections effective with young people

Less than one-third of acute stroke patients receive clot-busting drug within 60 minutes of hospital arrival

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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