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Generex Biotechnology announces FDA Expanded Access Treatment IND Program for Generex Oral-lyn

Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has expanded its plans for its United States Food and Drug Administration (FDA) Expanded Access Treatment IND Program for its flagship product, Generex Oral-lyn™, to include licensed and qualified Nurse Practitioners in the United States.

29 Mar 2010

Final results from Novavax' Phase II clinical trial of trivalent seasonal influenza VLP vaccine announced

Novavax, Inc. a clinical-stage vaccine company, released the final results from a Phase II clinical trial evaluating Novavax's trivalent seasonal influenza Virus-like particle (VLP) vaccine candidate in healthy adults. The study enrolled healthy volunteers 18 to 49 years in age who were immunized with a single injection of Novavax's trivalent seasonal influenza VLP vaccine matched to the influenza strains recommended for the 2008-2009 influenza vaccine.

29 Mar 2010

Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Ligand Pharmaceuticals Incorporated today announced that data from a Phase I study with its selective androgen receptor modulator (SARM) LGD-4033 was featured today in a poster presentation at the 14th International Congress of Endocrinology in Kyoto, Japan. This Phase I clinical trial was the first study in humans of LGD-4033, and evaluated the safety, tolerability and pharmacokinetic profiles of the molecule in a single escalating dose, double blind, placebo-controlled study in 48 healthy volunteers.

29 Mar 2010

Enrollment complete in Gemin X Pharmaceuticals' Phase 2 clinical trial of obatoclax for SCLC

Gemin X Pharmaceuticals, a clinical stage biopharmaceutical company developing novel, targeted cancer therapeutics, today announced the completion of patient enrollment in a Phase 2 clinical trial of the Company's lead product candidate obatoclax (GX15-070) for the treatment of extensive-stage small cell lung cancer (SCLC). The trial is designed to evaluate the efficacy and safety of obatoclax, a novel pan Bcl-2 inhibitor, in combination with standard chemotherapy for the first-line treatment of patients with SCLC.

29 Mar 2010

PROCAPS granted exclusive rights to commercialize Pro-Pharmaceuticals' DAVANAT in Colombia

Pro-Pharmaceuticals, Inc., a developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that it has granted PROCAPS S.A. exclusive rights to market and sell DAVANAT® to treat cancer in Colombia, South America. Phase ll clinical trial results for late-stage colorectal cancer patients demonstrate that when DAVANAT® is co-administered with the chemotherapy drug 5-FU, survival increased by 46% over the best standard of care and reduced serious adverse events associated with chemotherapy.

29 Mar 2010

StockPreacher.com announces investment report featuring ARCA biopharma

StockPreacher.com announces an investment report featuring ARCA biopharma Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

29 Mar 2010

Inovio Biomedical's total revenue increased to $2.6M for quarter ended December 31, 2009

Inovio Biomedical Corporation today reported financial results for the quarter and year ended December 31, 2009.

29 Mar 2010

Child-patient research subjects too often in the dark about their participation: Study

A small study of children with cancer enrolled in therapeutic clinical research trials shows that they don't fully understand what physicians and parents tell them about their participation, nor do they feel they are genuinely involved in the choice to take part.

29 Mar 2010

Cortex signs agreement to sell certain AMPAKINE compounds to Biovail

Cortex Pharmaceuticals, Inc. announced that it has entered into an agreement with Biovail Laboratories International SRL in which Biovail acquired certain AMPAKINE compounds and the rights to the patent filing for respiratory depression and vaso-occlusive crises associated with sickle cell disease.

29 Mar 2010

Role Tregs play in therapeutic HIV vaccines

Like a skittish driver slamming the brakes, a special class of T cells may be limiting the effectiveness of therapeutic vaccines for HIV by slowing the immune system response too soon, report University of Pittsburgh health science researchers in the current issue of PLoS ONE. Their study, the first to look at the role of regulatory T cells in therapeutic HIV vaccines, may help researchers improve the efficacy of such vaccines by devising methods to circumvent the braking mechanism of these cells.

27 Mar 2010

DSA to discuss challenges in drug development at Late Phase Drug Development World 2010

Drug Safety Alliance, a global leader in drug safety and pharmacovigilance, announced that Dr. Elizabeth Garrard, PharmD, RPh, would participate in “Late Phase Drug Development World 2010,” a first of its kind strategic forum addressing challenges in drug development.

27 Mar 2010

Thermo Fisher Scientific, Eli Lilly expand clinical trial materials supply chain relationship

Thermo Fisher Scientific Inc., the world leader in serving science, and biopharmaceutical company Eli Lilly and Company, announced today that they have expanded their clinical trial materials supply chain relationship. As part of a new five-year agreement, the Fisher Clinical Services business of Thermo Fisher will take over responsibility for Lilly’s in-house clinical trial materials manufacturing, packaging and labeling operations on-site at the Lilly Technology Center – North in Indianapolis. This transition is expected to be completed in the summer of 2010.

From Thermo Fisher Scientific Inc. 27 Mar 2010

Genome sequencing of tumors biopsied from women with invasive breast cancer

Tumors biopsied from women with invasive breast cancer are having their genomes sequenced in an attempt to develop a DNA profile that one day may identify ahead of time the patients who will most likely respond to chemotherapy with an aromatase inhibitor. Aromatase inhibitors are a class of chemotherapeutic agents that block the production of estrogen in postmenopausal women.

27 Mar 2010

READ 3 study for DME begins enrolling participants

A Phase II clinical trial for a promising treatment for diabetic eye disease has begun enrolling participants.

27 Mar 2010

ARCA biopharma granted patent for methods of treating heart failure patients with bucindolol based on genetic testing

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent on methods of treating heart failure patients with bucindolol based on genetic testing.

26 Mar 2010

Neurologix reports net loss of $13.5M for year ended December 31, 2009

Neurologix, Inc., a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, today announced its financial results for the year ended December 31, 2009.

26 Mar 2010

NCMHD announces $3.8M grant for research on minority recruitment in cancer clinical trials

The University of Minnesota Medical School today announced the details of a $3.8 million grant by the National Institutes of Health's National Center on Minority Health and Health Disparities for research focused on minority recruitment and retention in cancer clinical trials.

26 Mar 2010

Avid, Cardinal Health partner to detect Alzheimer's disease in living patients

Currently, Alzheimer's disease cannot be definitively diagnosed until after death, when a brain autopsy is performed on a patient and evidence of beta-amyloid plaque deposits in the brain – which are a characteristic pathology of the disease – can be found. Accurate diagnosis during life can be challenging, particularly in the early stages of Alzheimer's, when symptoms are mild and non-definitive. However, Avid Radiopharmaceuticals, Inc. and Cardinal Health are working together to change that.

26 Mar 2010

CTMS solutions provider TranSenda International acquired by BioClinica

BioClinica™, Inc.,, a global provider of clinical trial management services, today announced its acquisition of substantially all of the assets of privately held TranSenda International, LLC. Headquartered in Bellevue, WA, TranSenda is a provider of clinical trial management software (CTMS) solutions and is a Microsoft Gold Certified Partner.

From Clario 26 Mar 2010

Muscular dystrophy: $1M grant for study of erectile dysfunction drugs in improving muscle blood flow

A Cedars-Sinai Heart Institute cardiologist has been awarded a three-year, nearly $1 million grant from the Muscular Dystrophy Association (MDA) to study whether drugs used to treat erectile dysfunction could also be used to improve muscle blood flow and reduce fatigue in muscular dystrophy patients.

26 Mar 2010

Clinical Trial News and Research

Generex Biotechnology announces FDA Expanded Access Treatment IND Program for Generex Oral-lyn

Final results from Novavax' Phase II clinical trial of trivalent seasonal influenza VLP vaccine announced

Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Enrollment complete in Gemin X Pharmaceuticals' Phase 2 clinical trial of obatoclax for SCLC

PROCAPS granted exclusive rights to commercialize Pro-Pharmaceuticals' DAVANAT in Colombia

StockPreacher.com announces investment report featuring ARCA biopharma

Inovio Biomedical's total revenue increased to $2.6M for quarter ended December 31, 2009

Child-patient research subjects too often in the dark about their participation: Study

Cortex signs agreement to sell certain AMPAKINE compounds to Biovail

Role Tregs play in therapeutic HIV vaccines

DSA to discuss challenges in drug development at Late Phase Drug Development World 2010

Thermo Fisher Scientific, Eli Lilly expand clinical trial materials supply chain relationship

Genome sequencing of tumors biopsied from women with invasive breast cancer

READ 3 study for DME begins enrolling participants

ARCA biopharma granted patent for methods of treating heart failure patients with bucindolol based on genetic testing

Neurologix reports net loss of $13.5M for year ended December 31, 2009

NCMHD announces $3.8M grant for research on minority recruitment in cancer clinical trials

Avid, Cardinal Health partner to detect Alzheimer's disease in living patients

CTMS solutions provider TranSenda International acquired by BioClinica

Muscular dystrophy: $1M grant for study of erectile dysfunction drugs in improving muscle blood flow

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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