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Vaccinogen chooses Clinipace Worldwide to manage pivotal phase 3b confirmatory trial for OncoVAX

Clinipace Worldwide, a global full-service clinical research organization (CRO), announced today that Vaccinogen, a biotechnology company with more than three decades experience researching how to combat cancer using the body's own immune system, has selected the company to manage a pivotal phase 3b confirmatory trial for OncoVAX in the treatment of Stage II Colon Cancer.

6 May 2010

Acceleron Pharma commences Phase 2 clinical trial of ACE-031 protein therapeutic in DMD patients

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, today announced the initiation of a Phase 2 clinical trial with ACE-031 in patients with Duchenne Muscular Dystrophy (DMD), a fatal neuromuscular disease. ACE-031 is an investigational protein therapeutic that builds muscle and increases strength by inhibiting signaling of a cell surface receptor called the activin receptor type IIB (ActRIIB).

5 May 2010

Rockwell Medical first-quarter sales up 17.1%

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia, reported first quarter 2010 results today.

5 May 2010

Boehringer Ingelheim, Micromet enter collaboration for new BiTE antibody for multiple myeloma

Boehringer Ingelheim and Micromet, Inc. announced today that they have entered into a collaboration agreement for the research, development and commercialization of a new BiTE antibody for the treatment of multiple myeloma.

5 May 2010

Aradigm receives FDA IND approval for inhaled liposomal ciprofloxacin

Aradigm Corporation today announced it received clearance from the U.S. Food and Drug Administration (FDA) for its inhaled liposomal ciprofloxacin Investigational New Drug (IND) application. The first trial planned under this IND is a Phase 1/2a, multicenter study designed to evaluate the pharmacokinetics, safety, and tolerability of once-daily administration of 150 mg (3 mL) of Ciprofloxacin for Inhalation (CFI, ARD-3100) in pediatric patients with cystic fibrosis (CF) who have a history of chronic Pseudomonas aeruginosa lung infection.

5 May 2010

AMRI first-quarter total revenue down 9% to $49.3 million

AMRI today reported financial and operating results for the first quarter ended March 31, 2010.

5 May 2010

Cadence Pharmaceuticals resubmits OFIRMEV NDA

Cadence Pharmaceuticals, Inc. announced today that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational product candidate, OFIRMEV™ (acetaminophen) injection, for the treatment of pain and fever in adults and children.

5 May 2010

Merck acquires development, commercialization rights of ridaforolimus

Merck today announced that it has restructured its co-development and co-commercialization agreement with ARIAD Pharmaceuticals, Inc. for ridaforolimus, an investigational orally available mTOR inhibitor currently being evaluated for the treatment of multiple cancer types, to an exclusive license agreement.

5 May 2010

ARIAD restructures collaboration with Merck for ridaforolimus mTOR inhibitor

ARIAD Pharmaceuticals, Inc. today announced that it has restructured its July 2007 collaboration with Merck, Sharpe & Dohme Corp. for the development, manufacture, and commercialization of ridaforolimus - ARIAD's investigational mTOR inhibitor.

5 May 2010

Vical commences enrollment in Phase 1 trial of Vaxfectin DNA pandemic influenza vaccine

Vical Incorporated today announced the enrollment of the first subject in its Phase 1 trial of the company's Vaxfectin®-formulated plasmid DNA (pDNA) pandemic influenza vaccine. The trial will be conducted in collaboration with the U.S. Naval Medical Research Center (NMRC).

5 May 2010

Archivel Farma to start phase II clinical trials of RUTI vaccine for Latent Tuberculosis

Archivel Farma, S.L. has announced that its breakthrough treatment for tuberculosis (TB) will shortly start phase II clinical trials. The treatment uses the company's unique combination of its novel therapeutic vaccine called RUTI® in conjunction with an antibiotic. This cuts treatment time from nine months to one month, which reduces side effects and healthcare costs, by preventing re-infection during the eradication process. The company expects commercial availability in 2015.

5 May 2010

UK GTAC, MHRA approve Scancell's Phase I clinical trial of SCIB1 DNA ImmunoBody vaccine

Scancell Holdings Plc,, the developer of therapeutic cancer vaccines, today announced at BIO2010 in Chicago that its proposal to conduct a Phase I clinical trial on SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma, has been approved in the UK by the Gene Therapy Advisory Committee and by the Medicines and Healthcare products Regulatory Agency Medicines Division.

5 May 2010

Targeted antibiotics provide safe, long-lasting improvement for IBS patients, says study

A targeted antibiotic provides effective and long-lasting relief of Irritable Bowel Syndrome symptoms, according to the results of two multisite Phase III clinical trials designed by Cedars-Sinai researchers. Rifaximin is the first drug treatment for IBS that relieves symptoms while it's being administered and continues to benefit patients after they stop taking the drug.

5 May 2010

StemCells first-quarter total revenue up 307%

StemCells, Inc., a leading stem cell technology company with the dual focus of novel therapeutics and innovative research products, today reported financial results for the first quarter ended March 31, 2010 and recent business highlights.

5 May 2010

Alvine Pharmaceuticals reports data of ALV003 in gastric simulation model at DDW 2010

Alvine Pharmaceuticals, Inc., today announced the reporting of scientific data on the performance of its lead compound, ALV003, in a gastric simulation model. The data were presented at the 2010 Digestive Disease Week (DDW) meeting held in New Orleans, Louisiana.

5 May 2010

ChemoCentryx reports positive data with Traficet-EN in Crohn's disease trial

ChemoCentryx, Inc., today announced that it reported positive data with Traficet-EN™ (CCX282-B) in the Maintenance period of PROTECT-1 (Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial-1). Traficet-EN maintained a clinical remission rate (Crohn's Disease Activity Index (CDAI) less than 150) of approximately 50% in Crohn's patients over the course of 36 weeks, whereas in the placebo group remission decreased progressively from 50% to 31%.

5 May 2010

Anavex reports promising results from ANAVEX 2-73 Alzheimer's disease compound in animal studies

Anavex Life Sciences Corp. is pleased to report promising results from animal studies with ANAVEX 2-73, the company's lead compound for the treatment and modification of Alzheimer's disease.

5 May 2010

S*BIO, Onyx Pharmaceuticals expand development, commercialization collaboration for JAK2 Inhibitors

S*BIO Pte Ltd and Onyx Pharmaceuticals, Inc. today announced the expansion of their development collaboration and option and license commercialization agreement for S*BIO's novel JAK2 inhibitors, SB1518 and SB1578, also known as ONX 0803 and ONX 0805, respectively. The expanded agreement builds upon the development and commercialization collaboration between the two companies announced in January 2009.

5 May 2010

Results from STEALTH C-3 clinical trial of nitazoxanide presented at DDW 2010

Romark Laboratories announced results from its STEALTH C-3 clinical trial, a phase 2 clinical study of nitazoxanide in treatment-naive patients with genotype 1 chronic hepatitis C. Study results were presented this afternoon as an oral communication at a late breaking forum of the American Gastroenterological Association Institute during Digestive Disease Week 2010 in New Orleans, Louisiana.

5 May 2010

Additional pivotal Phase 3 trial data for MoxDuo IR released

QRxPharma announced today the release of additional pivotal Phase 3 trial data for MoxDuo IR, an immediate-release Dual-Opioid pain therapy. Required for New Drug Application submission with the United States Food and Drug Administration, this "combination rule" study compared the efficacy and safety profiles of MoxDuo IR against component doses of morphine and oxycodone alone for the management of moderate to severe post-operative pain following bunionectomy surgery.

5 May 2010

Drug Trial News

Vaccinogen chooses Clinipace Worldwide to manage pivotal phase 3b confirmatory trial for OncoVAX

Acceleron Pharma commences Phase 2 clinical trial of ACE-031 protein therapeutic in DMD patients

Rockwell Medical first-quarter sales up 17.1%

Boehringer Ingelheim, Micromet enter collaboration for new BiTE antibody for multiple myeloma

Aradigm receives FDA IND approval for inhaled liposomal ciprofloxacin

AMRI first-quarter total revenue down 9% to $49.3 million

Cadence Pharmaceuticals resubmits OFIRMEV NDA

Merck acquires development, commercialization rights of ridaforolimus

ARIAD restructures collaboration with Merck for ridaforolimus mTOR inhibitor

Vical commences enrollment in Phase 1 trial of Vaxfectin DNA pandemic influenza vaccine

Archivel Farma to start phase II clinical trials of RUTI vaccine for Latent Tuberculosis

UK GTAC, MHRA approve Scancell's Phase I clinical trial of SCIB1 DNA ImmunoBody vaccine

Targeted antibiotics provide safe, long-lasting improvement for IBS patients, says study

StemCells first-quarter total revenue up 307%

Alvine Pharmaceuticals reports data of ALV003 in gastric simulation model at DDW 2010

ChemoCentryx reports positive data with Traficet-EN in Crohn's disease trial

Anavex reports promising results from ANAVEX 2-73 Alzheimer's disease compound in animal studies

S*BIO, Onyx Pharmaceuticals expand development, commercialization collaboration for JAK2 Inhibitors

Results from STEALTH C-3 clinical trial of nitazoxanide presented at DDW 2010

Additional pivotal Phase 3 trial data for MoxDuo IR released

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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