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FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

Chelsea Therapeutics International, Ltd. announced confirmation by the U.S. Food and Drug Administration (FDA) that its proposed Phase II protocol for CH-4051 in rheumatoid arthritis has been approved by the agency.

26 Aug 2010

Octapharma completes clinical development of Uniplas human pooled plasma

Octapharma AG, one of the largest private manufacturers of plasma products in the world, announced today that the clinical development for Uniplas® has been successfully completed. The product has been filed for registration in Europe and will be submitted later in the USA.

26 Aug 2010

Phase 1 CRLX101 clinical study paves way for promising innovations in cancer therapy: Cerulean Pharma

Cerulean Pharma Inc., a leader in designing and developing nanopharmaceuticals, today announced that results of a Phase 1 clinical study of CRLX101 (formerly IT-101), Cerulean's lead clinical development candidate, and pre-clinical data on Cerulean's development candidate, CRLX288, were presented at the American Chemical Society National Meeting & Exposition, ongoing in Boston, Massachusetts.

26 Aug 2010

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced that it has completed enrollment of its ADVANCE-PD trial. ADVANCE-PD is a multinational Phase III trial of its late-stage product IPX066 in advanced Parkinson's disease (PD) patients with motor fluctuations. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management.

26 Aug 2010

Fox Chase Cancer Center to host Philadelphia Chromosome Symposium

In celebration of a seminal discovery in cancer biology, Fox Chase Cancer Center will host the Philadelphia Chromosome Symposium: Past, Present and Future, on September 28, 2010, from 8 a.m. to 7 p.m. at The Chemical Heritage Foundation, 315 Chestnut Street, Philadelphia. The event marks the 50th anniversary of the discovery of the first genetic abnormality associated with cancer, and the first to lead to a targeted therapy for cancer.

25 Aug 2010

NIH awards University of Rochester Medical Center $15M grant for study with ImmuneRegen's Homspera

ImmuneRegen BioSciences®, a wholly owned subsidiary of IR Biosciences Holdings Inc., today announced that the National Institute of Health/National Institute of Allergy and Infectious Disease, has awarded its research partner, the University of Rochester Medical Center (URMC), a $15 million five-year, continuation grant for studies that will utilize ImmuneRegen's Homspera.

25 Aug 2010

Stem cell therapy cures 12-year-old boy with diabetes

Cellonis Biotechnologies, a Beijing and HK-based medical research and application company, has recorded some remarkable results in the treatment of a twelve-year-old boy with diabetes using their stem cell therapy in a Beijing partner hospital. He has completely regained his normal life, enjoying sports and school activities just like every other person his age, and has been free from injections and drugs for more than half a year.

25 Aug 2010

Bioniche, University of Ottawa sign global technology license agreement for botanical therapeutics

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, together with the University of Ottawa, one of Canada's top ten research universities, today announced the signing of an exclusive global license agreement. The agreement provides commercial access for Bioniche to University of Ottawa's technology for botanical therapeutics (natural health) and pharmaceutical compounds for treating anxiety and related conditions in animal health, human health and aquaculture

25 Aug 2010

Adoption of standby intra-aortic balloon pump strategy during high-risk PCI needed: Study

High-risk patients undergoing a coronary procedure such as placement of a stent who electively received an intra-aortic balloon pump (a device that can help improve blood flow) prior to the procedure did not experience a significantly lower overall rate of events such as heart attack, revascularization or death, according to a study in the August 25 issue of JAMA.

25 Aug 2010

ZymoGenetics completes enrollment in Phase 2b PEG-IFN lambda clinical trial

ZymoGenetics, Inc. today announced enrollment has been completed in the Phase 2b clinical trial with PEG-Interferon lambda and ribavirin in chronic hepatitis C virus (HCV) infection.

25 Aug 2010

Warner Chilcott receives FDA response to citizen petition for ASACOL and ASACOL HD products

Warner Chilcott plc today announced that it has received the Food and Drug Administration's response to a citizen petition it had filed regarding its ASACOL and ASACOL HD products.

25 Aug 2010

Scientists discover Magnetic Resonance Spectroscopy can rapidly diagnose degenerative disorders

Magnetic Resonance Spectroscopy can distinguish between neurological diseases in patients without clear symptoms.A team of American scientists claim that a new method of testing for neurological diseases could provide doctors with a rapid and non-invasively method of diagnosing degenerative disorders.

25 Aug 2010

3Sbio, Isotechnika Pharma sign development and commercialization agreement for voclosporin inhibitor

Isotechnika Pharma Inc., a biopharmaceutical company focused on the discovery and development of immune modulating therapeutics, and 3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced the signing of a development and commercialization agreement for voclosporin, a next generation calcineurin inhibitor being developed for use in the prevention of organ rejection following transplantation and the treatment of autoimmune diseases.

25 Aug 2010

SureGene collaborates with Medco Health Solutions to conduct REST study

SureGene, LLC and the Medco Research Institute, LLC, a wholly-owned subsidiary of Medco Health Solutions, Inc., today announced that they have entered into a novel investigative research collaboration to evaluate whether variation in genetic biomarkers previously identified by SureGene can help predict drug response for widely prescribed antipsychotic drugs in patients with serious mental illness.

25 Aug 2010

Study examines movement of pediatric drug testing outside the U.S.

"A law intended to speed up development of new drugs for U.S. kids has ended up financing clinical trials in poor countries, where the medicines might never become available," suggest the authors of a study published online Monday in the journal Pediatrics, Reuters reports (Joelving, 8/23).

25 Aug 2010

Access Pharmaceuticals to highlight Cobalamin nanotechnology at ACS National Meeting

ACCESS PHARMACEUTICALS, INC.,a biopharmaceutical company specializing in products for cancer and supportive care, announced that its Director of Chemistry and Quality, Dr. Ric Zarzycki will give an invited presentation today on the Company's Cobalamin nanoparticle technology at a thought-leadership symposium being held at the American Chemical Society's ("ACS") 240th National Meeting & Exposition, at Boston Convention and Exhibition Center in Boston, Massachusetts, August 22-26, 2010.

25 Aug 2010

3SBio and Isotechnika enter strategic agreement for voclosporin in China

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products and Isotechnika Pharma Inc., a biopharmaceutical company focused on the discovery and development of immune modulating therapeutics, today announced the signing of a development and commercialization agreement for voclosporin.

24 Aug 2010

Pharmasset commences dosing in PSI-7977 Phase 2b study for chronic hepatitis C

Pharmasset, Inc. announced today that dosing has begun in a Phase 2b study of PSI-7977, a nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (HCV). The trial will evaluate PSI-7977 200mg QD and 400mg QD in combination with pegylated interferon alfa 2a and ribavirin, the current standard of care (SOC) in patients with HCV genotype 1 who have not been treated previously.

24 Aug 2010

LabCorp launches IL-28B gene test for HCV infection

Laboratory Corporation of America® Holdings announced today the nationwide availability of a genetic test to detect the presence of a single polymorphism within the IL-28B gene that has been reported to help predict a person's response to certain hepatitis C virus (HCV) therapies.

24 Aug 2010

Research on OGF-OGFr complex helps to understand pathobiology of diseases

Researchers at The Pennsylvania State University College of Medicine, Hershey, Pennsylvania have discovered that the Opioid Growth Factor (OGF, [Met5]-enkephalin) and its receptor, OGFr, a clinically important system with potent antitumor properties, has controlled entry from the cytoplasm to the nucleus. The nucleocytoplasmic passage of OGF-OGFr is critical to cell proliferation and suggests that there are hierarchical levels of nuclear import.

24 Aug 2010

Efficacy News and Research

FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

Octapharma completes clinical development of Uniplas human pooled plasma

Phase 1 CRLX101 clinical study paves way for promising innovations in cancer therapy: Cerulean Pharma

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

Fox Chase Cancer Center to host Philadelphia Chromosome Symposium

NIH awards University of Rochester Medical Center $15M grant for study with ImmuneRegen's Homspera

Stem cell therapy cures 12-year-old boy with diabetes

Bioniche, University of Ottawa sign global technology license agreement for botanical therapeutics

Adoption of standby intra-aortic balloon pump strategy during high-risk PCI needed: Study

ZymoGenetics completes enrollment in Phase 2b PEG-IFN lambda clinical trial

Warner Chilcott receives FDA response to citizen petition for ASACOL and ASACOL HD products

Scientists discover Magnetic Resonance Spectroscopy can rapidly diagnose degenerative disorders

3Sbio, Isotechnika Pharma sign development and commercialization agreement for voclosporin inhibitor

SureGene collaborates with Medco Health Solutions to conduct REST study

Study examines movement of pediatric drug testing outside the U.S.

Access Pharmaceuticals to highlight Cobalamin nanotechnology at ACS National Meeting

3SBio and Isotechnika enter strategic agreement for voclosporin in China

Pharmasset commences dosing in PSI-7977 Phase 2b study for chronic hepatitis C

LabCorp launches IL-28B gene test for HCV infection

Research on OGF-OGFr complex helps to understand pathobiology of diseases

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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