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CryoLife granted FDA approval for BioFoam human clinical trial

CryoLife, Inc., an implantable biological medical device and cardiovascular tissue processing company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology.

27 Oct 2009

Hope for lung cancer patients

Lung cancer is the world's most common cancer, and an estimated 219,440 Americans are expected to be diagnosed this year. It is also estimated that lung cancer will cause 159,000 deaths in the United States this year - more than the total number of deaths resulting from breast, colon and prostate cancers combined.

27 Oct 2009

Alkermes commences ALKS 37 phase 1 clinical trial for the treatment of opioid-induced constipation

Alkermes, Inc. today announced the initiation of a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the opioid agonist effects on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetic effects of a single oral administration of five doses of ALKS 37 in approximately 40 healthy volunteers.

27 Oct 2009

ImmunoCellular Therapeutics presents additional data from its ICT-107 Phase I clinical trial

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is focused on the development of novel immune-based cancer therapies, today announced additional data from its Phase I clinical trial evaluating ICT-107, the Company’s dendritic-cell based cancer vaccine product candidate for the treatment of glioblastoma multiforme (GBM).

27 Oct 2009

BioSphere submits an IDE to the FDA for its QuadraSphere Microsphere product

BioSphere Medical, Inc. – the leader in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy – today announced the submission to the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) application for a clinical trial for the use of BioSphere’s QuadraSphere® Microsphere product (QuadraSphere) to deliver the chemotherapeutic agent doxorubicin for the treatment of primary liver cancer.

27 Oct 2009

Positive results from Phase II clinical trial of INT-747 announced

Intercept Pharmaceuticals, Inc., today announced positive results from a 165 patient, placebo controlled, double-blind Phase II clinical trial of INT-747 in patients with primary biliary cirrhosis (PBC).

27 Oct 2009

Positive results from Logical Therapeutics' Phase I/II LT-NS001 clinical study

Logical Therapeutics, Inc., a Waltham, MA-based biopharmaceutical company announced today the positive results of a Phase I/II clinical trial evaluating the gastrointestinal (GI) safety of its investigational drug LT-NS001, the first of a new class of bio-activated prodrugs being developed for the chronic treatment of arthritic conditions.

27 Oct 2009

Astellas enters into agreement with Medivation to develop MDV3100

Astellas Pharma Inc. ("Astellas") and Medivation, Inc. announced today that they have entered into a global agreement to develop and commercialize MDV3100, Medivation's investigational drug for the treatment of prostate cancer.

27 Oct 2009

Lexicon Pharmaceuticals reports fiscal 2009 third-quarter results and updates of its clinical trials

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 and nine months ended September 30, 2009.

27 Oct 2009

New therapy for decreasing anxiety and improving psychological well-being in children

A group of investigators of the University of Bologna suggest a new way of approaching emotional disturbances in children by improving their psychological well-being. The study is published in the current issue of Psychotherapy and Psychosomatics.

27 Oct 2009

Phase 2 clinical study of PEG-Interferon lambda commenced

ZymoGenetics, Inc. today announced the initiation of a Phase 2 clinical trial of PEG-Interferon lambda (IL-29) and ribavirin in treatment-naïve patients with chronic hepatitis C virus (HCV) infection (the “EMERGE” study).

27 Oct 2009

Patient receives left-ventricular assist device to improve heart function

UT Southwestern Medical Center patient Michael LeBlanc, 40, is the first in North Texas to receive the newest generation of a mechanical device designed to improve heart function. It will be his lifeline while he awaits a heart transplant.

27 Oct 2009

New data on KAPIDEX for nighttime heartburn in adults with non-erosive GERD presented at the 2009 ACG

New data being presented at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting in San Diego showed that treatment with KAPIDEX(TM) (dexlansoprazole) delayed release capsules over a four-week period resulted in a statistically significant greater percentage of nights without heartburn in subjects with non-erosive gastroesophageal reflux disease (GERD), compared to placebo (p<0.001).

27 Oct 2009

Study shows gene therapy can restore vision to children with Leber congenital amaurosis

Results from a breakthrough study, conducted by researchers at The Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania School of Medicine, show that gene therapy has restored significant vision in five children and seven adults who were previously blind.

27 Oct 2009

Arzerra drug approved by FDA for treating chronic lymphocytic leukemia

The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.

27 Oct 2009

FDA approves Berinert for adults and adolescents with HAE

The U.S. Food and Drug Administration today approved Berinert, the first treatment for acute abdominal attacks and facial swelling associated with a rare and potentially life-threatening genetic disease called hereditary angioedema (HAE).

27 Oct 2009

Clinical trial helps improve prognosis and changes the standard of care for patients with colorectal cancer

In a review article published this month in The Oncologist, UNC's Dr. Richard M. Goldberg and a team of colleagues catalogue how the data collected in a single large comparative clinical trial testing combination chemotherapy for metastatic colorectal cancer has been used not only to benefit the patients that enrolled but also patients who subsequently developed the disease.

27 Oct 2009

ImmunoCellular Therapeutics to present Phase I clinical trial data of ICT-107 vaccine in New Orleans

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a clinical-stage biotechnology company that is developing immune-based therapies for the treatment of brain and other cancers, today announced that it will be presenting today, at the Annual Meeting of the Congress of Neurological Surgeons in New Orleans, Louisiana at 3:15pm central time, data from its Phase I clinical trial investigating the role that its ICT-107 vaccine may play in increasing patient survival and inhibiting tumor progression in patients with glioblastoma, the most common and most aggressive type of primary brain tumor.

26 Oct 2009

Phase 2a clinical trial in nonsense mutation hemophilia A and hemophilia B initiated

PTC Therapeutics, Inc. (PTC) today announced it is expanding the development of ataluren, an investigational new drug, to a third indication with the initiation of a Phase 2a clinical trial in nonsense mutation hemophilia A (nmHA) and hemophilia B (nmHB).

26 Oct 2009

Cel Sci completes its production facility for Multikine Phase III clinical trial

BioMedReports, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors, was given an exclusive tour of CEL-SCI Corporation's, new, state-of-the-art manufacturing facility near Baltimore, MD where the potentially ground breaking cancer immunotherapy treatment, Multikine, will be manufactured to support an upcoming Phase III clinical trial.

26 Oct 2009

Clinical Trial News and Research

CryoLife granted FDA approval for BioFoam human clinical trial

Hope for lung cancer patients

Alkermes commences ALKS 37 phase 1 clinical trial for the treatment of opioid-induced constipation

ImmunoCellular Therapeutics presents additional data from its ICT-107 Phase I clinical trial

BioSphere submits an IDE to the FDA for its QuadraSphere Microsphere product

Positive results from Phase II clinical trial of INT-747 announced

Positive results from Logical Therapeutics' Phase I/II LT-NS001 clinical study

Astellas enters into agreement with Medivation to develop MDV3100

Lexicon Pharmaceuticals reports fiscal 2009 third-quarter results and updates of its clinical trials

New therapy for decreasing anxiety and improving psychological well-being in children

Phase 2 clinical study of PEG-Interferon lambda commenced

Patient receives left-ventricular assist device to improve heart function

New data on KAPIDEX for nighttime heartburn in adults with non-erosive GERD presented at the 2009 ACG

Study shows gene therapy can restore vision to children with Leber congenital amaurosis

Arzerra drug approved by FDA for treating chronic lymphocytic leukemia

FDA approves Berinert for adults and adolescents with HAE

Clinical trial helps improve prognosis and changes the standard of care for patients with colorectal cancer

ImmunoCellular Therapeutics to present Phase I clinical trial data of ICT-107 vaccine in New Orleans

Phase 2a clinical trial in nonsense mutation hemophilia A and hemophilia B initiated

Cel Sci completes its production facility for Multikine Phase III clinical trial

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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