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Newborn Possibilities program for babies at-risk for neurological injury

For every 1,000 children born in the U.S. today, two to three are at risk for developing cerebral palsy because of injuries to the brain that may have occurred prior to or during birth. There is currently no cure for cerebral palsy, but Newborn Possibilities is a first-of-its-kind program recently launched in Tucson, which may offer new options for newborns at-risk for neurological injury.

23 Feb 2010

Acute stroke care and clinical outcomes improve substantially with stroke program

Acute stroke care and clinical outcomes have improved significantly at hospitals participating in the American Heart Association/American Stroke Association's Get With The Guidelines-Stroke program, according to a large study in Circulation: Cardiovascular Quality and Outcomes, a journal of the American Heart Association.

23 Feb 2010

Heartware completes patient enrollment for ADVANCE clinical trial

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced the conclusion of patient enrollment under its "ADVANCE" clinical trial.

23 Feb 2010

DURECT, Nycomed amend POSIDUR Development and License Agreement

DURECT Corporation announced today that Nycomed and DURECT have amended the Development and License Agreement entered into between the parties in 2006 covering the development and commercialization of POSIDUR™ (also known as SABER™-Bupivacaine or OPTESIA™), an investigational drug for the treatment of post-surgical pain.

23 Feb 2010

Cancer Institute awards MCRA designation to Cooper University Hospital

Enhancing its collective strength in the area of oncology research in the state, The Cancer Institute of New Jersey has announced that Cooper University Hospital will be the fourth affiliate hospital within its Network to receive the prestigious Major Clinical Research Affiliate designation.

23 Feb 2010

Senate, FDA reports increasing concerns about controversial diabetes drug

"Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market ... ," The New York Times reports. "The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline."

23 Feb 2010

Enzymerx completes enrollment for clinical trial of pegsitacase

EnzymeRx, LLC, a clinical-stage biotechnology company, announced completion of the enrollment of its first clinical trial of pegsitacase (formerly called Uricase-PEG 20), and the recent launch of a second clinical study. Pegsitacase is a pegylated uricase being developed by EnzymeRx for the treatment of refractory gout and for the management of hyperuricemia associated with tumor lysis syndrome.

22 Feb 2010

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

BioSante Pharmaceuticals, Inc., today announced additional positive safety data in its ongoing LibiGel Phase III clinical development program. For the second time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review, the DMC once again unanimously recommended continuation of the study as described in the FDA-agreed LibiGel safety study protocol, with no modifications.

22 Feb 2010

Two genetic alterations linked to benign enzyme condition keep hepatitis C patients anemia-free

Many people who undergo treatment for hepatitis C develop hemolytic anemia, a disorder that destroys red blood cells. In some cases, it is so severe they have to reduce their medication or stop therapy altogether. But now, scientists in Duke University's Institute for Genome Sciences & Policy have discovered two genetic alterations linked to a benign enzyme condition that keep some patients anemia-free.

21 Feb 2010

OrthoAccel Technologies promotes AcceleDent System for enhancing orthodontics at 7th IOC

OrthoAccel Technologies, Inc., developers of the AcceleDent System, which is an acceleration device to enhance orthodontics, recently exhibited at the 7th International Orthodontic Congress (IOC) in Sydney, Australia, which is held by the World Federation of Orthodontists (WFO) every five years. The 8th IOC in 2015 will be hosted in London.

20 Feb 2010

Emory School of Medicine to enroll nearly 1,140 people for Phase III clinical trial of progesterone for TBI

Researchers at 17 medical centers across the country soon will begin using the hormone progesterone to treat patients who experience traumatic brain injury (TBI). The treatment is part of a randomized, double-blind Phase III clinical trial that will enroll approximately 1,140 people over a three- to six-year period beginning in March, 2010. The trial is funded by a grant to Emory University from the National Institutes of Health.

20 Feb 2010

BioCrossroads' Indiana Seed Fund invests $400,000 in Bioscience Vaccines

BioCrossroads' Indiana Seed Fund has invested in Bioscience Vaccines, Inc. to accelerate the development of biologic materials, which may boost the effectiveness of a wide range of life-saving vaccines.

19 Feb 2010

Neovasc completes final tranche of previously announced non-brokered private placement

Neovasc Inc. today announced that it has completed the final tranche of a previously announced non-brokered private placement. The aggregate gross proceeds of the financing totaled $1.537 million through placement of approximately 5.692 million units at a price of $0.27 per unit, comprised of a first tranche of $1.329 million announced January 28, 2010 and this second tranche of $208,000.

19 Feb 2010

Embrella Embolic Deflector device highlighted during JIM 2010 meeting in Rome

Embrella Cardiovascular™, Inc., a privately held company announced that the Embrella Embolic Deflector™ device was highlighted during a live case transmission last week at the Joint Interventional Meeting (JIM) in Rome, Italy.

19 Feb 2010

Delay in Vibativ's approval for nosocomial pneumonia to reduce previously forecasted commercial impact

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that delays in the U.S. approval and launch of Theravance/Astellas's Vibativ (telavancin) for the treatment of nosocomial pneumonia will reduce by more than half the commercial impact that it was previously forecasted to garner in the methicillin-resistant Staphylococcus aureus (MRSA) drug market.

19 Feb 2010

AGH neurosurgeons explore new therapeutic approach for brain tumor

Neurosurgeons at Allegheny General Hospital (AGH) are exploring use of a drug that illuminates brain tumor cells to determine if the experimental visualization technique will enhance their ability to surgically excise tumors and improve patient survival.

19 Feb 2010

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

Novartis announced today that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

19 Feb 2010

Echo Therapeutics makes significant advance in designing Symphony tCGM device

Echo Therapeutics, Inc., a company developing the needle-free Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude™ SkinPrep System for transdermal drug delivery, announced today that the Company has made a significant advance in the product design of its Symphony tCGM device and that it has developed its next generation electronic component package.

19 Feb 2010

Two UCSF scientists selected for Potamkin Prize for their achievements in research on dementias

Two UCSF scientists have been selected for the American Academy of Neurology's prestigious Potamkin Prize, for their "outstanding achievements" in research on dementias.

19 Feb 2010

Neuralstem raises $5.25M, also receives NYSE Amex compliance notice

Neuralstem, Inc. announced today that it has raised a total of $5,228,000 since the beginning of the year, comprised of a previously disclosed $1.5 million private placement of 646,551 common shares at $2.32, priced at a 30 percent premium over the market on the closing, and approximately $3.7 million from warrant exercises.

19 Feb 2010

Clinical Trial News and Research

Newborn Possibilities program for babies at-risk for neurological injury

Acute stroke care and clinical outcomes improve substantially with stroke program

Heartware completes patient enrollment for ADVANCE clinical trial

DURECT, Nycomed amend POSIDUR Development and License Agreement

Cancer Institute awards MCRA designation to Cooper University Hospital

Senate, FDA reports increasing concerns about controversial diabetes drug

Enzymerx completes enrollment for clinical trial of pegsitacase

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

Two genetic alterations linked to benign enzyme condition keep hepatitis C patients anemia-free

OrthoAccel Technologies promotes AcceleDent System for enhancing orthodontics at 7th IOC

Emory School of Medicine to enroll nearly 1,140 people for Phase III clinical trial of progesterone for TBI

BioCrossroads' Indiana Seed Fund invests $400,000 in Bioscience Vaccines

Neovasc completes final tranche of previously announced non-brokered private placement

Embrella Embolic Deflector device highlighted during JIM 2010 meeting in Rome

Delay in Vibativ's approval for nosocomial pneumonia to reduce previously forecasted commercial impact

AGH neurosurgeons explore new therapeutic approach for brain tumor

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

Echo Therapeutics makes significant advance in designing Symphony tCGM device

Two UCSF scientists selected for Potamkin Prize for their achievements in research on dementias

Neuralstem raises $5.25M, also receives NYSE Amex compliance notice

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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