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QLT's Phase II olopatadine punctal plug delivery system trial demonstrates safety in allergic conjunctivitis patients

QLT Inc. today announced results from a Phase II proof-of-concept clinical trial for the olopatadine punctal plug delivery system (O‑PPDS).

9 Feb 2011

Humira and Enbrel have best overall clinical profile for treatment of moderate to severe psoriasis: Survey

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of moderate to severe psoriasis, the highest proportion of surveyed dermatologists and managed care organizations' (MCOs) pharmacy directors indicate that Abbott/Eisai's Humira and Amgen/Pfizer/Stiefel/Takeda's Enbrel have the best overall clinical profile when compared to other currently available agents.

9 Feb 2011

FDA proposes new Innovation Pathway program for pioneering medical devices

Today the U.S. Food and Drug Administration proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly.

9 Feb 2011

Revo pacemaker receives FDA approval for use during certain MRI exams

The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

9 Feb 2011

Nine thousand patients to take part in Nowegian study on opening of narrowed coronary arteries

Nine thousand patients will take part in a clinical trial to determine the best method of opening narrowed coronary arteries. The results of the study may lead to substantial cost savings - and save lives.

9 Feb 2011

Medicago granted FDA clearance for clinical development of seasonal flu vaccine

Medicago Inc. a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced it has received Food and Drug Administration ("FDA") clearance for its phase I H1N1 influenza VLP vaccine candidate ("H1N1 vaccine") clinical trial in the United States.

9 Feb 2011

Pervasis' Vascugel granted Fast Track review status for prevention of hemodialysis access failure in ESRD patients

Pervasis Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track review status for Vascugel® for the prevention of hemodialysis access failure in patients with end stage renal disease (ESRD).

9 Feb 2011

CytRx's bafetinib helps reduce skeletal complications in cancer patients

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that results from a series of preclinical studies show that bafetinib may be useful in preventing bone loss in cancer patients who are at high risk for this event.

8 Feb 2011

Rib-X commences Phase 2b trial to assess delafloxacin, linezolid, vancomycin for treatment of ABSSSI

Rib-X Pharmaceuticals, an antibiotics company with a broad development-stage pipeline, today announced the initiation of a Phase 2b clinical trial to evaluate delafloxacin, linezolid and vancomycin for the treatment of acute bacterial skin and skin structure infections, including infections caused by methicillin-resistant Staphylococcus aureus.

8 Feb 2011

International research team receives AACR award for innovative, meritorious science

The Fifth Annual AACR Team Science Award will be given to a team of internationally renowned molecular biologists, epidemiologists, biostatisticians and clinicians from Fred Hutchinson Cancer Research Center and University of Washington who have worked together on human papillomavirus for more than 20 years.

8 Feb 2011

Elan 2010 total revenue increases 5% to $1,169.7 million

Elan Corporation, plc today reported its fourth quarter and full-year 2010 financial results and provided financial guidance for 2011.

8 Feb 2011

Cleveland Clinic, JumpStart Ventures invest $500,000 in SironRX Therapeutics

JumpStart Ventures, the non-profit that invests in and partners with innovative, early-stage companies in Northeast Ohio, and Cleveland Clinic, announced a combined investment commitment of $500,000 in SironRX Therapeutics, Inc. The Cleveland-based company is developing a topical therapy to enhance healing of and decrease scar formation in wounds.

8 Feb 2011

Transition reports second quarter 2011 net income of $24.28M vs. $6.05M net loss for second quarter 2010

Transition Therapeutics Inc., a product-focused biopharmaceutical company developing therapeutics for disease indications with large markets, today announced its financial results for the quarter ended December 31, 2010.

8 Feb 2011

PharmaMar initiates PM060184 Phase I clinical trial in patients with solid tumors

PharmaMar SA has announced the commencement of a Phase I clinical trial with PM060184 for patients with solid tumors. PM060184 is a marine-derived, synthetically-produced compound which has shown strong in vitro and in vivo antitumor activity and a favorable safety profile in preclinical toxicology studies. PM060184 is PharmaMar's sixth compound in clinical development.

7 Feb 2011

Harbor BioSciences closes U.S.-based Apoptone Phase I/IIa clinical trial for castration resistant prostate cancer

Harbor BioSciences, Inc., a biopharmaceutical company developing novel therapeutics for the treatment of cancer, metabolic and inflammatory diseases, today announced it is closing the clinical sites of its U.S.-based Phase I/IIa clinical trial with Apoptone® (HE3235) for castration resistant prostate cancer (CRPC) – also referred to as hormone resistant prostate cancer.

7 Feb 2011

SANUWAVE Health raises $4,102,660 from exercise of Options

SANUWAVE Health, Inc., an emerging medical technology company focused on regenerative medicine, announces that it has raised gross proceeds of $4,102,660 from the exercise of Options that were issued as part of the sale of Units to accredited investors during 2010. The Options had an expiration date of January 31, 2011.

7 Feb 2011

AstraZeneca, Targacept commence TC-5214 Phase 2b clinical trial for major depressive disorder

AstraZeneca and Targacept, Inc. today announced initiation of a Phase 2b clinical trial of TC-5214, a nicotinic channel blocker, as a "switch" monotherapy treatment for patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant therapy. This study is in addition to the companies' Phase 3 RENAISSANCE Program for TC-5214 as an adjunctive treatment for MDD.

7 Feb 2011

Curaxis President comments on new Alzheimer's Association report

Patrick S. Smith, President and Chief Executive Officer of Curaxis Pharmaceutical Corp., commented today on a new report by the Alzheimer's Association, titled "Generation Alzheimer's – the defining disease of the baby boomers", which demonstrates the devastating impact and size of Alzheimer's disease.

7 Feb 2011

Genomic study identifies link between Native American ancestry, relapse in young leukemia patients

The first genome-wide study to demonstrate an inherited genetic basis for racial and ethnic disparities in cancer survival linked Native American ancestry with an increased risk of relapse in young leukemia patients. The work was done by investigators at St. Jude Children's Research Hospital and the Children's Oncology Group.

6 Feb 2011

FDA approves Makena injection to reduce risk of preterm delivery

The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.

5 Feb 2011

Clinical Trial News and Research

QLT's Phase II olopatadine punctal plug delivery system trial demonstrates safety in allergic conjunctivitis patients

Humira and Enbrel have best overall clinical profile for treatment of moderate to severe psoriasis: Survey

FDA proposes new Innovation Pathway program for pioneering medical devices

Revo pacemaker receives FDA approval for use during certain MRI exams

Nine thousand patients to take part in Nowegian study on opening of narrowed coronary arteries

Medicago granted FDA clearance for clinical development of seasonal flu vaccine

Pervasis' Vascugel granted Fast Track review status for prevention of hemodialysis access failure in ESRD patients

CytRx's bafetinib helps reduce skeletal complications in cancer patients

Rib-X commences Phase 2b trial to assess delafloxacin, linezolid, vancomycin for treatment of ABSSSI

International research team receives AACR award for innovative, meritorious science

Elan 2010 total revenue increases 5% to $1,169.7 million

Cleveland Clinic, JumpStart Ventures invest $500,000 in SironRX Therapeutics

Transition reports second quarter 2011 net income of $24.28M vs. $6.05M net loss for second quarter 2010

PharmaMar initiates PM060184 Phase I clinical trial in patients with solid tumors

Harbor BioSciences closes U.S.-based Apoptone Phase I/IIa clinical trial for castration resistant prostate cancer

SANUWAVE Health raises $4,102,660 from exercise of Options

AstraZeneca, Targacept commence TC-5214 Phase 2b clinical trial for major depressive disorder

Curaxis President comments on new Alzheimer's Association report

Genomic study identifies link between Native American ancestry, relapse in young leukemia patients

FDA approves Makena injection to reduce risk of preterm delivery

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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