Clinical Trial News and Research

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Oral salmon calcitonin using absorption-enhancing Eligen Technology holds promise for osteoarthritis

Emisphere Technologies, Inc. announced study results in which twice-daily oral salmon calcitonin using Emisphere’s proprietary Eligen® Drug Delivery Technology significantly suppressed markers of cartilage and bone degradation versus placebo in men and women with osteoarthritis, the most common form of arthritis.

19 Oct 2009

Angiochem reports Phase 1/2 efficacy study results of ANG1005 for treating brain cancer

Angiochem, Inc. a clinical-stage biotechnology company developing drugs that are uniquely capable of crossing the blood-brain barrier to treat brain diseases, announced today that its lead drug candidate, ANG1005, has demonstrated a favorable safety and efficacy profile in more than 100 patients with brain cancer from two separate Phase 1 /2 clinical studies in patients with progressive gliomas, including recurrent glioblastoma, and in patients with progressive brain metastases.

19 Oct 2009

Angiochem announces results of Phase 1 /2 clinical trials of ANG1005

19 Oct 2009

Rituxan's sBLA receives a Complete Response from the FDA

Genentech, Inc. a wholly-owned member of the Roche Group, and Biogen Idec announced today that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX.

19 Oct 2009

Study to examine the impact of LASIK procedure on patients’ quality of life

The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

19 Oct 2009

Novel HIV drug to be studied in cell cultures and patients

A $6 million, five-year federal grant to The Children's Hospital of Philadelphia Research Institute will enable researchers to investigate a novel approach in treating HIV infection---a unique class of drugs focused on developing therapies for psychological and neurological effects in AIDS.

19 Oct 2009

Biogen Idec and Biovitrum to conduct rFIXFc clinical trial in hemophilia B patients

Biogen Idec and Biovitrum AB (STO: BVT) today announced that they plan to advance the companies’ long-acting, fully-recombinant Factor IX Fc fusion protein (rFIXFc) into a registrational clinical trial in hemophilia B patients.

19 Oct 2009

Phase I clinical study of PENNVAX-B preventive DNA vaccine using electroporation technology

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced today the initiation of a phase I clinical study of Inovio’s PENNVAX-B preventive DNA vaccine delivered using its proprietary electroporation technology.

19 Oct 2009

Recently approved Gleevec drug for cancer treatment

Investigators have identified a drug that is currently approved to treat certain types of cancer, Gleevec, that could provide the first treatment for scleroderma, a chronic connective tissue disease for which a treatment has remained elusive. The news will be presented at the annual meeting of the American College of Rheumatology on October 18 in Philadelphia.

19 Oct 2009

GlaxoSmithKline receives FDA approval for cervical cancer vaccine

GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

19 Oct 2009

China's SFDA approves Celsion’s global Phase III ThermoDox HEAT trial for treating liver cancer

Celsion Corporation announced today that it has received official approval from China’s State Food and Drug Administration (“SFDA”) for its Clinical Trial Application for ThermoDox that permits Celsion to include Chinese clinical trial sites in its Phase III ThermoDox HEAT trial for the treatment of primary liver cancer, also known as hepatocellular carcinoma (HCC).

15 Oct 2009

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated enrollment in its confirmatory Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating orBec(®) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD).

15 Oct 2009

Inspire to present its denufosol tetrasodium cystic fibrosis program data at the 23rd NACFC

Inspire Pharmaceuticals, Inc. announced today Inspire scientists and collaborators will present data from the denufosol tetrasodium cystic fibrosis (CF) program in a poster presentation at the 23rd Annual North American Cystic Fibrosis Conference (NACFC) October 15 - 17, 2009 in Minneapolis, MN.

15 Oct 2009

Sangretech Biomedical signs amended license agreement with Bostwick Laboratories

Sangretech Biomedical LLC, a developer of dendritic cell therapies for cancer and infectious diseases, today announced it has executed an amended and restated license agreement with Bostwick Laboratories, Inc. providing Bostwick Scientific, the research division of Bostwick Laboratories, with exclusive rights to Sangretech’s dendritic cell technology in certain territories.

15 Oct 2009

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

Protalix BioTherapeutics, Inc., announced today positive top-line results from the Company's pivotal Phase III clinical trial of UPLYSO (taliglucerase alfa, previously referred to as prGCD) in treatment naive patients diagnosed with Gaucher disease.

15 Oct 2009

Medifacts International bags $2.7 million contract with a top ten pharmaceutical company

MEDIFACTS INTERNATIONAL, INC., one of the largest global providers of noninvasive cardiac diagnostic services, today announced the award of a $2.7 million contract with a top ten pharmaceutical company to provide comprehensive cardiac safety and efficacy services for a large late stage clinical trial.

15 Oct 2009

pSivida achieves milestone in Phase III Iluvien trial, last patient completes two-year follow up visit

pSivida Corp., a leading drug delivery company that has developed two of the only three products approved by the FDA for the long-term, sustained release delivery of drug to treat chronic back of the eye disease, today announced that the last patient in the Phase III clinical trial being conducted by its collaborative partner, Alimera Sciences, for a new treatment for diabetic macular edema (DME) has completed the two-year follow up visit.

15 Oct 2009

Phase Forward and Merck project wins the Society for Clinical Data Management Data Driven Innovation Award

Phase Forward, a leading provider of data management solutions for clinical trials and drug safety, today announced that a joint project with customer Merck & Co. has won the 2009 Society for Clinical Data Management (SCDM) Data Driven Innovation Award competition. This annual honor recognizes the year’s best advancement in clinical data management technology or service.

15 Oct 2009

Endoscope: Less invasive alternative to laparoscopic techniques or conventional surgery

Mayo Clinic surgical researchers are reporting a 93 percent success rate in recent animal tests of endoscopic repair of perforated ulcers. The goal is to advance the use of an endoscope -- which allows access to organs through natural openings, such as the mouth -- for a less invasive alternative to laparoscopic techniques (surgery performed through a small incision) or conventional surgery.

15 Oct 2009

Health Sciences South Carolina, Recombinant Data and Sun Microsystems to collaborate on an Integrated Platform for Research

Health Sciences South Carolina (HSSC), today announced that it has selected Recombinant Data Corp. and Sun Microsystems, Inc. to collaborate on the Health Sciences South Carolina Integrated Platform for Research (HS-SCIPR), an unprecedented statewide initiative for translational research and quality improvement.

15 Oct 2009

Clinical Trial News and Research

Oral salmon calcitonin using absorption-enhancing Eligen Technology holds promise for osteoarthritis

Angiochem reports Phase 1/2 efficacy study results of ANG1005 for treating brain cancer

Angiochem announces results of Phase 1 /2 clinical trials of ANG1005

Rituxan's sBLA receives a Complete Response from the FDA

Study to examine the impact of LASIK procedure on patients’ quality of life

Novel HIV drug to be studied in cell cultures and patients

Biogen Idec and Biovitrum to conduct rFIXFc clinical trial in hemophilia B patients

Phase I clinical study of PENNVAX-B preventive DNA vaccine using electroporation technology

Recently approved Gleevec drug for cancer treatment

GlaxoSmithKline receives FDA approval for cervical cancer vaccine

China's SFDA approves Celsion’s global Phase III ThermoDox HEAT trial for treating liver cancer

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Inspire to present its denufosol tetrasodium cystic fibrosis program data at the 23rd NACFC

Sangretech Biomedical signs amended license agreement with Bostwick Laboratories

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

Medifacts International bags $2.7 million contract with a top ten pharmaceutical company

pSivida achieves milestone in Phase III Iluvien trial, last patient completes two-year follow up visit

Phase Forward and Merck project wins the Society for Clinical Data Management Data Driven Innovation Award

Endoscope: Less invasive alternative to laparoscopic techniques or conventional surgery

Health Sciences South Carolina, Recombinant Data and Sun Microsystems to collaborate on an Integrated Platform for Research

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