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BioClinica board authorizes $2.0 million share repurchase program

BioClinica®, Inc.,, a global provider of clinical trial management services, announced that its Board of Directors has authorized a share repurchase program of up to $2.0 million of the Company's common stock over the next 18 months.

From Clario 17 Dec 2010

Early intervention can improve core symptoms of ASD in young children: Study

In a study recently published in the Journal of Child Psychology and Psychiatry (Epub ahead of print), researchers from the Kennedy Krieger Institute found that early intervention can improve the core symptoms of autism spectrum disorders in very young children.

17 Dec 2010

FDA's decision on Avastin will take away choice for many patients, says Breastcancer.org

Dr. Marisa Weiss, president and founder of Breastcancer.org and a breast oncologist in the Philadelphia area submitted a letter to the U.S. Food and Drug Administration prior to the Oncology Drug Advisory Committee (ODAC) meeting to review data for Avastin's use in metastatic HER2-negative breast cancer. In light of today's news that the FDA has recommended removing Avastin's approval to treat breast cancer, Breastcancer.org is making public Dr. Weiss' ODAC letter in its entirety.

17 Dec 2010

MDA awards Repligen $1.4M for research of new compound with therapeutic potential for SMA

The Muscular Dystrophy Association today announced it has awarded $1.4 million in new research funding to the biopharmaceutical firm Repligen of Waltham, Mass., to complete the preclinical work needed to begin human clinical trials of a promising therapeutic compound for spinal muscular atrophy (SMA).

17 Dec 2010

FDA recommends removal of breast cancer indication from Avastin label

The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

17 Dec 2010

FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

Novavax, Inc. announced today that the company's Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food and Drug Administration (FDA) and is no longer on clinical hold. In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.

16 Dec 2010

GSK to deploy BioClinica's Trident IWR system across Phase I-IV clinical trials

BioClinica®, Inc.,, a global provider of clinical trial management services, today announced that GlaxoSmithKline LLC ("GSK") has signed a multi-year enterprise technology agreement to deploy BioClinica's Trident IWR (Interactive Web Response) system across its Phase I-IV clinical trials.

From Clario 16 Dec 2010

Discovery Labs awarded NIH Fast Track SBIR grant for developing aerosolized KL4 surfactant for RDS

Discovery Laboratories, Inc. today announced that the Company has been awarded Phase I of a Fast Track Small Business Innovation Research Grant (SBIR) from the National Institutes of Health (NIH) to support the development of the Company's program for aerosolizing KL4 surfactant for neonatal respiratory distress syndrome (RDS).

16 Dec 2010

Adeona expands and enhances zinc-based product candidate portfolio

Adeona Pharmaceuticals, Inc., a developer of innovative medicines for serious central nervous system diseases, announced today that it has acquired access to clinical data supporting a zinc-based therapy for the prevention of infections in the elderly. This acquisition expands and enhances Adeona's zinc-based product candidate portfolio that already includes its proprietary zinc-based tablets for use in the dietary management of mild to moderate Alzheimer's disease and mild cognitive impairment patients, and age-related macular degeneration.

16 Dec 2010

Miracor granted CE-Mark for PICSO Impulse System to improve ACS revascularization following PCI

Miracor Medical Systems GmbH announced today that the company has received CE-mark for the PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) Impulse System, designed to improve acute coronary syndrome (ACS) revascularization following primary percutaneous coronary intervention (PCI).

16 Dec 2010

MDA commits to invest funds in FSMA Quinazoline Program

The MDA has committed to invest funds in the FSMA Quinazoline Program at Repligen Corporation to assist in advancing the program to an IND filing with the FDA.

16 Dec 2010

CEL-SCI receives Ukraine government approval for Multikine Phase III clinical trial in head and neck cancer

CEL-SCI Corporation announced today it has received governmental approval from the Health Authority, Ministry of Health of Ukraine, to begin enrollment of subjects for a Phase III clinical trial of Multikine® in Ukraine. Multikine is the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. Ukraine is one of nine countries to participate in this global Phase III trial. The Phase III trial will be run at about 48 clinical centers, of which about 6 centers will be in Ukraine.

16 Dec 2010

$Phase 1b clinical trial of JX-594 in metastatic, refractory colorectal cancer commences in Korea$

Phase 1b clinical trial of JX-594 in metastatic, refractory colorectal cancer commences in Korea

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, and Transgene, a bio-pharmaceutical company specialized in the development of immunotherapeutic products, today announced that enrollment and treatment of patients in a Phase 1b clinical trial has been initiated to evaluate JX-594 in patients with advanced metastatic, refractory colorectal cancer (CRC).

16 Dec 2010

Novel adenovirus-based gene therapy for renal cell carcinoma

Researchers at Virginia Commonwealth University Massey Cancer Center and the VCU Institute of Molecular Medicine (VIMM) have developed a novel virus-based gene therapy for renal cell carcinoma that has been shown to kill cancer cells not only at the primary tumor site but also in distant tumors not directly infected by the virus. Renal cell carcinoma is the most common form of kidney cancer in adults and currently there is no effective treatment for the disease once it has spread outside of the kidney.

16 Dec 2010

MDA supports Repligen with $1.4M grant for RG3039 Spinal Muscular Atrophy development program

Repligen Corporation today announced that the Company has received $1,400,000 in research funding from the Muscular Dystrophy Association ("MDA") to support the ongoing development of RG3039 for Spinal Muscular Atrophy ("SMA"). RG3039, our lead compound, is an inhibitor of an RNA processing enzyme which targets increased production of SMN, a protein of deficient levels in patients with SMA.

15 Dec 2010

Yorkshire Cancer Research to grant over GBP1.26 million for research at universities of Leeds and Sheffield

Yorkshire Cancer Research (YCR) is set to give more than GBP1.26 million of funding to researchers at the universities of Leeds and Sheffield next year.

15 Dec 2010

CTT, Bayer sign Research and License Option Agreement

Cancer Targeted Technology (CTT), a Seattle-based biotechnology firm focusing on small molecule cancer enzyme inhibitors for the generation of novel diagnostics and therapeutics, today announced that it has signed a Research and License Option Agreement with Bayer Pharma AG, Germany. Under the agreement, CTT will work with Bayer to optimize a novel PET imaging agent based on its unique inhibitor scaffold that recognizes a validated cancer enzyme biomarker.

15 Dec 2010

MHRA issues notice of acceptance for BioMarin's GALNS Phase 3 trial in MPS IVA

BioMarin Pharmaceutical Inc. today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has completed review of the Clinical Trial Application (CTA) and issued a notice of acceptance for the Phase 3 trial of N-acetylgalactosamine 6-sulfatase (GALNS) for the treatment of Mucopolysaccharidosis IVA (MPS IVA). The company expects to initiate the Phase 3 pivotal trial early in the first quarter of 2011.

15 Dec 2010

Positive results from large, multi-center Canadian trial with On-X Prosthetic Heart Valve

On-X® Life Technologies, Inc., today announced the publication of results of a large, prospective multi-center Canadian trial with the On-X® Prosthetic Heart Valve in the November issue of The Journal of Thoracic and Cardiovascular Surgery.1 According to the results of the report, "The On-X mechanical prosthesis provides favorable intermediate-term results with regard to major thromboembolism, hemorrhage and composites of valve-related complications."

15 Dec 2010

Study broadens understanding of role of IDH1 and IDH2 mutations in AML

Agios Pharmaceuticals, the leading biopharmaceutical company focused on discovering and developing novel drugs in the rapidly emerging field of cancer metabolism, today announced the publication of a paper in Cancer Cell that illuminates the mechanism by which 2-hydroxyglutarate (2HG), and the mutations in the metabolic genes IDH1 and IDH2 that produce it, may be driving the growth of tumors in patients with acute myeloid leukemia (AML).

15 Dec 2010

Clinical Trial News and Research

BioClinica board authorizes $2.0 million share repurchase program

Early intervention can improve core symptoms of ASD in young children: Study

FDA's decision on Avastin will take away choice for many patients, says Breastcancer.org

MDA awards Repligen $1.4M for research of new compound with therapeutic potential for SMA

FDA recommends removal of breast cancer indication from Avastin label

FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

GSK to deploy BioClinica's Trident IWR system across Phase I-IV clinical trials

Discovery Labs awarded NIH Fast Track SBIR grant for developing aerosolized KL4 surfactant for RDS

Adeona expands and enhances zinc-based product candidate portfolio

Miracor granted CE-Mark for PICSO Impulse System to improve ACS revascularization following PCI

MDA commits to invest funds in FSMA Quinazoline Program

CEL-SCI receives Ukraine government approval for Multikine Phase III clinical trial in head and neck cancer

Phase 1b clinical trial of JX-594 in metastatic, refractory colorectal cancer commences in Korea

Novel adenovirus-based gene therapy for renal cell carcinoma

MDA supports Repligen with $1.4M grant for RG3039 Spinal Muscular Atrophy development program

Yorkshire Cancer Research to grant over GBP1.26 million for research at universities of Leeds and Sheffield

CTT, Bayer sign Research and License Option Agreement

MHRA issues notice of acceptance for BioMarin's GALNS Phase 3 trial in MPS IVA

Positive results from large, multi-center Canadian trial with On-X Prosthetic Heart Valve

Study broadens understanding of role of IDH1 and IDH2 mutations in AML

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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