Clinical Trial News and Research

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WuXi PharmaTech's Shanghai c-GMP manufacturing facility receives MPA compliance certificate

WuXi PharmaTech (WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced today that it received the formal certificate of GMP compliance from the Medical Products Agency (MPA) of Sweden, acting on behalf of the European Medicines Agency (EMEA), for its c-GMP drug product manufacturing and analytical testing facilities located in Shanghai.

24 Feb 2010

Catalyst Pharmaceutical Partners, NIDA partner to conduct CPP-109 Phase II(b) clinical trial for cocaine addiction

Catalyst Pharmaceutical Partners, Inc. announced today that it has signed a non-binding Letter of Intent with the National Institute on Drug Abuse (NIDA) to conduct a U.S. Phase II(b) clinical trial evaluating CPP-109, Catalyst's formulation of vigabatrin, for the treatment of cocaine addiction. It is anticipated that NIDA, under their agreement with Veteran's Administration Cooperative Studies Program, will provide substantial resources for the trial and that Catalyst will contribute approximately $2.5 million in resources as part of the estimated $10 million trial cost.

23 Feb 2010

Cephalon to acquire Ception Therapeutics following positive clinical study of eosinophilic asthma

Cephalon, Inc. (Nasdaq: CEPH) announced today that it has exercised its option to acquire Ception Therapeutics, Inc., following receipt of positive data from a clinical study in adults with eosinophilic asthma.

23 Feb 2010

Lexicon Pharmaceuticals reports positive results from Phase 2 clinical trials for IBS and type 2 diabetes

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three months and year ended December 31, 2009.

23 Feb 2010

Gross sales of Acorda Therapeutics' ZANAFLEX CAPSULES and tablets increase 9.1% to $58.3M in 2009

Acorda Therapeutics, Inc. today announced its financial results for the fourth quarter and full year ended December 31, 2009.

23 Feb 2010

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

Clinical Trial News and Research

WuXi PharmaTech's Shanghai c-GMP manufacturing facility receives MPA compliance certificate

Catalyst Pharmaceutical Partners, NIDA partner to conduct CPP-109 Phase II(b) clinical trial for cocaine addiction

Cephalon to acquire Ception Therapeutics following positive clinical study of eosinophilic asthma

Lexicon Pharmaceuticals reports positive results from Phase 2 clinical trials for IBS and type 2 diabetes

Gross sales of Acorda Therapeutics' ZANAFLEX CAPSULES and tablets increase 9.1% to $58.3M in 2009

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

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