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Iverson Genetic Diagnostics receives CMS approval for Warfarin clinical study

Iverson Genetic Diagnostics today announced the company has received approval from CMS to conduct a WARFARIN Clinical Study. The two-year (2) study will assess the impact of genetic information in calculating doses and the changes in the rate of adverse events when initiating Warfarin drug therapy. These changes will be compared against doses initiated without genetic data. The randomized and blinded, multi-center study will involve more than 7000 participants at over 50 sites nationwide.

27 Jul 2010

Study on interactions between new antitubercular drug candidates SQ109 and TMC207

Sequella, Inc., a clinical-stage biopharmaceutical company developing drugs for treatment of life-threatening infectious diseases, announced today the publication of studies in the scientific journal Antimicrobial Agents and Chemotherapy on synergy between SQ109, its lead drug candidate for the treatment of TB, and TMC207, Tibotec lead TB drug candidate:

27 Jul 2010

Idenix second-quarter total revenues decrease to $1.3 million

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the second quarter and six months ended June 30, 2010. At June 30, 2010, Idenix's cash and cash equivalents totaled $51.0 million.

27 Jul 2010

QRxPharma reports positive outcome of European Scientific Advice meetings on MoxDuo IR pain therapy

QRxPharmareported today positive outcomes of its European Scientific Advice meetings on the development and registration of MoxDuo IR, an immediate release Dual-Opioid™ pain therapy. The Company is currently completing pivotal Phase 3 trials required for filing a New Drug Application (NDA) for MoxDuo IR with the United States Food and Drug Administration (FDA).

26 Jul 2010

Seaside Therapeutics reports positive data from STX209 Phase 2 study in fragile X syndrome

Seaside Therapeutics, Inc. announced today data from the largest randomized, placebo-controlled study conducted to date in individuals with fragile X syndrome. In a Phase 2 study of STX209, clinically meaningful improvements on global and specific neurobehavioral outcomes were observed in the general study population. The improvements were statistically significant in pediatric patients with more severe impairments in sociability -- a core symptom of fragile X syndrome.

26 Jul 2010

Can-Fite's CF102 decreases HCV viral load in liver cancer patients

Can-Fite BioPharma Ltd, a biotechnology company traded on the Tel Aviv Stock Exchange reported today that a significant decrease in HCV viral load was detected in 3 patients with liver cancer who are treated daily orally with CF102. The company is studying CF102 as a treatment for liver cancer (hepatocellular carcinoma, or HCC). The results announced today relate to data which came out of a Phase 1/2 clinical trial of CF102 in the treatment of patients with advanced HCC.

26 Jul 2010

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced the start of a U.S. Phase I clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia, an important step on the road toward introducing a biosimilar product in the United States. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.

26 Jul 2010

AVEO's initiation of AV-299 Phase 2 trial for lung cancer triggers $750,000 milestone payment to XOMA

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced receipt of a $750,000 milestone payment under its collaboration with AVEO Pharmaceuticals, Inc.. The milestone payment resulted from AVEO's recent initiation of a Phase 2 clinical trial to evaluate its AV-299 antibody for the treatment of non-small cell lung cancer. AV-299 is a humanized antibody to hepatocyte growth factor (HGF).

26 Jul 2010

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Onyx Pharmaceuticals, Inc. today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

26 Jul 2010

Vical's prophylactic Vaxfectin-formulated pDNA vaccine effective against HSV-2 in animal model

Vical Incorporated today announced that its prophylactic Vaxfectin®-formulated plasmid DNA (pDNA) vaccine against herpes simplex virus type 2 (HSV-2) protected mice against lethal challenge, provided sterilizing immunity and inhibited viral counts at both the primary and latent infection sites. The Vaxfectin® adjuvant substantially improved vaccine effectiveness. A related vaccine significantly reduced the recurrence of HSV-2 lesions in a therapeutic model using guinea pigs with latent infection.

26 Jul 2010

ESC concerned over interpretation of JUPITER sub-analysis trial results about HDL cholesterol

The European Society of Cardiology (ESC) is concerned that interpretations of a paper about cholesterol, published in the Lancet, could act to deter ongoing research efforts into developing new therapeutic strategies to increase high density lipoprotein (HDL) cholesterol. Caution, the ESC experts advise, should be displayed in the interpretation of the results.

26 Jul 2010

Cerenis, Novasep awarded French Government funding for development of CER-001 HDL mimetic

Cerenis Therapeutics SA (Cerenis), a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and other metabolic diseases, and Groupe Novasep (Novasep), a leading supplier of manufacturing solutions to the life sciences industries, announce today that they have received French Government funding through OSEO to finance the development of CER-001, a Cerenis HDL mimetic.

26 Jul 2010

L2FU reports 100% recovery of recent study's lost clinical trial patients

Recovering unnecessarily lost patient information is now a viable reality. Lost to follow up rates in clinical research trials can range from 20- 60%. As a result, patients who drop from a clinical trial and 'go missing' can impart a major set-back in pharmaceutical research. Failure to contact patients and obtain final closure data, or bring them back into the clinical trial (if the protocol allows) results in study delays, increased patient recruitment costs, compromised study data, and in some cases an insufficient amount of information to prove the safety and efficacy of a drug.

26 Jul 2010

North Shore-LIJ Health System seeks oropharynx patients for phase I clinical trial

The North Shore-LIJ Health System Department of Radiation Medicine announced today it is seeking patients with cancer of the oropharynx (back of the mouth) to participate in a Phase I clinical trial.Subjects must be newly diagnosed and not have undergone any previous treatment. Further, their cancer must be unassociated with the human papilloma virus (HPV-negative), or, if it is HPV-positive, they must be current or former pack-a-day smokers for at least 10 years.

26 Jul 2010

Experimental treatment for sickle cell disease enters Phase 3 clinical trials

An experimental treatment for sickle cell disease developed at the Los Angeles Biomedical Research Institute has entered Phase 3 clinical trials, David I. Meyer, PhD, LA BioMed president and CEO announced today.

26 Jul 2010

First patient enrolled in Phase 3 SyNAPSe study of BHR-100 for TBI

BHR Pharma, LLC announced today that the first patient has been enrolled in its SyNAPSe study, a global, Phase 3, pivotal trial to evaluate the safety and effectiveness of its intravenous progesterone infusion product (BHR-100) as a neuroprotective agent for treating severe (Glasgow Coma Scale scores of 4-8) traumatic brain injury patients.

23 Jul 2010

Tarsa Therapeutics completes patient enrollment in Phase III ORACAL trial of oral calcitonin

Unigene Laboratories, Inc. today noted that Tarsa Therapeutics has completed patient enrollment in the Phase III ORACAL trial of Tarsa's oral calcitonin product for the treatment of postmenopausal osteoporosis. Unigene licensed the product to Tarsa and owns 26% of the company.

23 Jul 2010

Update on Phase III Study of oral calcitonin for treatment of osteoarthritis

Emisphere Technologies, Inc. today announced that Novartis Pharma AG and its license partner Nordic Bioscience a/s have reported the following in connection with their Phase III Study 2302 in osteoarthritis assessing the safety and efficacy of oral calcitonin in the treatment of osteoarthritis of the knee.

23 Jul 2010

Novartis, Nordic Bioscience to continue oral calcitonin Phase III study in osteoarthritis patients

Unigene Laboratories, Inc. announced today that Novartis and its license partner Nordic Bioscience have decided to continue the companies' two-year, Phase III Study 2302 assessing safety and efficacy of oral calcitonin in patients with osteoarthritis of the knee. Novartis has a worldwide license to produce recombinant calcitonin under Unigene's patented SecraPep® E. coli manufacturing technology.

23 Jul 2010

Early HAART during TB treatment prolongs survival of untreated HIV-infected adults: CAMELIA study

A clinical trial in Cambodia has found it possible to prolong the survival of untreated HIV-infected adults with very weak immune systems and newly diagnosed tuberculosis (TB) by starting anti-HIV therapy two weeks after beginning TB treatment, rather than waiting eight weeks, as has been standard.

23 Jul 2010

Drug Trial News

Iverson Genetic Diagnostics receives CMS approval for Warfarin clinical study

Study on interactions between new antitubercular drug candidates SQ109 and TMC207

Idenix second-quarter total revenues decrease to $1.3 million

QRxPharma reports positive outcome of European Scientific Advice meetings on MoxDuo IR pain therapy

Seaside Therapeutics reports positive data from STX209 Phase 2 study in fragile X syndrome

Can-Fite's CF102 decreases HCV viral load in liver cancer patients

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

AVEO's initiation of AV-299 Phase 2 trial for lung cancer triggers $750,000 milestone payment to XOMA

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Vical's prophylactic Vaxfectin-formulated pDNA vaccine effective against HSV-2 in animal model

ESC concerned over interpretation of JUPITER sub-analysis trial results about HDL cholesterol

Cerenis, Novasep awarded French Government funding for development of CER-001 HDL mimetic

L2FU reports 100% recovery of recent study's lost clinical trial patients

North Shore-LIJ Health System seeks oropharynx patients for phase I clinical trial

Experimental treatment for sickle cell disease enters Phase 3 clinical trials

First patient enrolled in Phase 3 SyNAPSe study of BHR-100 for TBI

Tarsa Therapeutics completes patient enrollment in Phase III ORACAL trial of oral calcitonin

Update on Phase III Study of oral calcitonin for treatment of osteoarthritis

Novartis, Nordic Bioscience to continue oral calcitonin Phase III study in osteoarthritis patients

Early HAART during TB treatment prolongs survival of untreated HIV-infected adults: CAMELIA study

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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