Clinical Trial News and Research

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Diamyd's NP2 Enkephalin Phase II study in cancer pain posted on ClinicalTrials.gov

Diamyd Medical´s US Phase II clinical trial, evaluating the ability of the candidate drug NP2 Enkephalin to reduce cancer pain, is posted on the ClinicalTrials.gov website.

10 Feb 2011

Early amniotomy on first time mothers can shorten delivery time by 10%

In a study to be presented today at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting -, in San Francisco, researchers will present findings that show that by performing an amniotomy on first time mothers in situations when labor has to be induced, that delivery time can be shortened by more than 10 percent.

10 Feb 2011

First patient treated in cytomegalovirus~ACE/ASPECT Phase II randomised clinical trial

Cell Medica, a leading UK cellular therapeutics company that develops, manufactures and markets cellular immunotherapy products for the treatment of infectious disease and cancer, announces today that the first patient has been treated in the CMV~ACE/ASPECT trial at University College Hospital London.

10 Feb 2011

Hormone 17-Hydroxyprogesterone does not reduce rate of preterm delivery in twin pregnancies: Study

In a study to be presented today at the Society for Maternal-Fetal Medicine's (SMFM) annual meeting, The Pregnancy Meeting -, in San Francisco, researchers will present findings that show that the use of the hormone 17-Hydroxyprogesterone does not reduce the rate of preterm delivery or neonatal complications in twins.

10 Feb 2011

New rotary-powered device for bone marrow aspiration, biopsy yields superior samples with less pain

For many cancer patients, a bone marrow biopsy and/or aspiration is one of the most dreaded aspects of their diagnosis and treatment plan. The traditional method for gaining bone marrow involves grinding a needle by hand through a patient's skin and bone, and the procedure is often described as extremely painful.

10 Feb 2011

OraSure registers $3.5 million net loss for full year 2010

OraSure Technologies, Inc., a market leader in oral fluid diagnostics, today announced revenues of $75.0 million and $18.8 million for the year and quarter ended December 31, 2010, respectively. This compares to revenues of $77.0 million and $20.9 million for the year and quarter ended December 31, 2009.

10 Feb 2011

Cephalon to acquire Alba Therapeutics

Cephalon, Inc. and Alba Therapeutics Corporation, a privately held biopharmaceutical company, today announced that the companies have signed an agreement providing Cephalon with an option to purchase all of Alba's assets relating to larazotide acetate, a tight junction modulator, progressing toward a Phase IIb clinical trial for the treatment of celiac disease.

10 Feb 2011

New study: Fetal surgery for spina bifida greatly improves child's mobility

Performing delicate surgery in the womb, months before birth, can substantially improve outcomes for children with a common, disabling birth defect of the spine. Experts at The Children's Hospital of Philadelphia co-led a new landmark study showing that fetal surgery for spina bifida greatly reduces the need to divert fluid from the brain, improves mobility and improves the chances that a child will be able to walk independently.

9 Feb 2011

PolyMedix commences PMX-60056 Phase 2 clinical trial in patients undergoing PCI

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has initiated a Phase 2 clinical trial, following conclusion of a review by the United States Food and Drug Administration (FDA) of a protocol submitted by PolyMedix, to assess the safety and efficacy of its heptagonist, PMX-60056, in reversing heparin in patients undergoing Percutaneous Coronary Intervention (PCI) procedures.

9 Feb 2011

Repligen third quarter total revenue increases 26% to $7,068,000

Repligen Corporation today reported results for the third quarter of fiscal year 2011, ended December 31, 2010. Total revenue for the quarter was $7,068,000 compared to total revenue of $5,617,000 for the third quarter of fiscal year 2010 ended December 31, 2009, an increase of $1,451,000 or 26%.

9 Feb 2011

GeoVax opens second HIV clinical trial site at Alabama Vaccine Research Clinic

GeoVax Labs, Inc., a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today the opening of a second clinical trial site at the Alabama Vaccine Research Clinic (AVRC) of the University of Alabama at Birmingham (UAB) to expand the company's HIV therapeutic vaccine trial.

9 Feb 2011

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

Clinical Trial News and Research

Diamyd's NP2 Enkephalin Phase II study in cancer pain posted on ClinicalTrials.gov

Early amniotomy on first time mothers can shorten delivery time by 10%

First patient treated in cytomegalovirus~ACE/ASPECT Phase II randomised clinical trial

Hormone 17-Hydroxyprogesterone does not reduce rate of preterm delivery in twin pregnancies: Study

New rotary-powered device for bone marrow aspiration, biopsy yields superior samples with less pain

OraSure registers $3.5 million net loss for full year 2010

Cephalon to acquire Alba Therapeutics

New study: Fetal surgery for spina bifida greatly improves child's mobility

PolyMedix commences PMX-60056 Phase 2 clinical trial in patients undergoing PCI

Repligen third quarter total revenue increases 26% to $7,068,000

GeoVax opens second HIV clinical trial site at Alabama Vaccine Research Clinic

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

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