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Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

CTI second-quarter total net operating expenses decrease to $20.0 million

Cell Therapeutics, Inc. today reported recent accomplishments and financial results for the second quarter ended June 30, 2010.

5 Aug 2010

ARIAD reports $159.3 million second-quarter net income

ARIAD Pharmaceuticals, Inc. today reported financial results for the second quarter and six months ended June 30, 2010 and provided an update on corporate developments.

5 Aug 2010

Genzyme, Isis announce results of two mipomersen phase 3 studies

Genzyme Corp. and Isis Pharmaceuticals Inc. today announced results of two phase 3 studies of mipomersen in patients who had high cholesterol levels while on maximally tolerated lipid-lowering therapy. In the study of patients with severe hypercholesterolemia, mipomersen reduced LDL-C, the primary endpoint, by 36 percent compared with a 13 percent increase for placebo.

5 Aug 2010

Alnylam second-quarter revenues increase to $26.6 million

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today reported its consolidated financial results for the second quarter ended June 30, 2010, and company highlights.

5 Aug 2010

ImmunoGen fourth-quarter 2010 net loss increases to $13.4 million

ImmunoGen, Inc., a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced financial results for the three-month period and fiscal year ended June 30, 2010.

5 Aug 2010

Anthera second-quarter total operating expenses increase to $7.9 million

Anthera Pharmaceuticals, Inc., today announced financial results and business highlights for the second quarter ended June 30, 2010.

5 Aug 2010

FDA issues Lux Biosciences Complete Response letter for Luveniq NDA

Lux Biosciences, Inc. today announced that the U.S. Food and Drug Administration's Center of Drug Evaluation and Research has issued a Complete Response letter regarding the New Drug Application (NDA) for Luveniq™ (oral voclosporin) for the treatment of non-infectious uveitis.

5 Aug 2010

Acceleron's ACE-031 protein therapeutic for DMD receives FDA Fast Track designation

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 it received FDA Fast Track designation for ACE-031 for the treatment of Duchenne Muscular Dystrophy (DMD), a fatal neuromuscular disease in which patients suffer from the progressive loss of muscle mass and strength. ACE-031 is an investigational protein therapeutic being developed to increase muscle mass and strength.

5 Aug 2010

Infinity reports $18.4 million total revenue for second-quarter 2010

Infinity Pharmaceuticals, Inc., an innovative drug discovery and development company, today detailed recent developments in its product development portfolio and announced second quarter 2010 financial results.

4 Aug 2010

NCI panel recommends Celsion's Phase III ThermoDox HEAT Study as Priority Clinical Trial for HCC

Celsion Corporation announced today that the consensus recommendations of the National Cancer Institute (NCI) Clinical Trials Planning Meeting (CTPM) for Hepatocellular Carcinoma have been released and published in the August 2010 issue of Journal of Clinical Oncology, the official publication of American Society of Clinical Oncology (ASCO). In addition to evaluating the current standard of care, the NCI panel also recommended Celsion's Phase III ThermoDox ® HEAT Study as a Priority Clinical Trial for HCC.

4 Aug 2010

Contrave added to diet and exercise regimen can induce significant weight loss

Orexigen Therapeutics, Inc. announced the online publication of results from its COR-BMOD trial of Contrave (naltrexone SR/bupropion SR) in the journal Obesity. The COR-BMOD trial evaluated intensive behavior modification plus Contrave32 (32mg naltrexone sustained release (SR)/360mg bupropion SR) compared to BMOD plus placebo, in 793 overweight or obese patients.

4 Aug 2010

Access Pharmaceuticals initiates Phase I/II dose escalating study for Thiarabine

Access Pharmaceuticals, Inc., today announced it has initiated a Phase I/II dose-escalating study of its proprietary, anti-cancer drug, Thiarabine, a nucleoside analog for patients with hematologic malignancies (cancers of the blood). The primary objective of the study is to determine the maximum tolerated dose (MTD) in two different dosing schedules with various leukemias and lymphomas and recommended Phase II dose. The program is being led by Hagop Kantarjian, M.D., Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center in Houston, Texas.

4 Aug 2010

Advaxis receives India’s DCGI approval for ADXS11-001 Phase II clinical trial for cervical cancer

Advaxis, Inc.,, the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, has received formal permission from the Drugs Controller General India (DCGI) to conduct a Phase II clinical trial of ADXS11-001, the Company's flagship drug construct, among 110 women with advanced, metastatic cervical cancer that has progressed subsequent to treatment with cytotoxic therapy. 55 women will receive ADXS11-001 alone, 55 will receive a combined regimen of both ADXS11-001 and cytotoxic therapy.

4 Aug 2010

Glycotope receives German, Italian regulatory approval for CetuGEX Phase I study for solid cancers

Glycotope GmbH, a leading glycobiology company, has received regulatory approval by German and Italian regulatory authorities for a Phase I study of Glycotope´s next generation antibody CetuGEX™ (GT-MAB 5.2-GEX) for the treatment of various solid cancers.

4 Aug 2010

$CTI files SPA with FDA for new pixantrone phase III trial in relapsed or refractory aggressive B-Cell NHL$

CTI files SPA with FDA for new pixantrone phase III trial in relapsed or refractory aggressive B-Cell NHL

Cell Therapeutics, Inc. today announced it has filed for a Special Protocol Assessment ("SPA") with the U.S. Food and Drug Administration ("FDA") for the design of its new phase III trial of pixantrone for patients with relapsed or refractory aggressive B-Cell non-Hodgkin's lymphoma ("NHL").

4 Aug 2010

ZymoGenetics second-quarter net loss declines to $3.8 million

ZymoGenetics, Inc. today reported substantially improved financial results for the quarter ended June 30, 2010. For the second quarter of 2010, the company's net loss declined to $3.8 million, or $0.04 per share, a $23.2 million improvement from the $27.0 million loss, or $0.39 per share, reported for the second quarter of 2009. The improvement resulted from higher revenues as well as reduced operating expenses.

4 Aug 2010

Excaliard reports positive results from EXC 001 Phase 2 clinical trial for reducing scar severity

Excaliard Pharmaceuticals, Inc., today announced positive results from its Phase 2 clinical trial of EXC 001, a new chemical entity for reducing fibrosis. Results showed that EXC 001 treatment significantly reduced scar severity in subjects undergoing an elective abdominoplasty compared to placebo.

4 Aug 2010

Titan completes 60% enrollment in confirmatory Phase 3 clinical study of Probuphine for opioid addiction

Titan Pharmaceuticals, Inc. today announced that patient enrollment is more than 60% complete in the confirmatory Phase 3 clinical study of Probuphine for the treatment of opioid addiction, and the study is expected to complete enrollment by early fourth quarter of this year, which is almost three months ahead of schedule.

3 Aug 2010

Vical second-quarter revenues decrease to $2.1 million

Vical Incorporated today reported financial results for the three months and six months ended June 30, 2010. Revenues decreased to $2.1 million for the second quarter of 2010 from $4.0 million for the second quarter of 2009, primarily as a result of a $1.5 million milestone payment in 2009 from Merck & Co., Inc., based on Merck's ongoing Phase 1 clinical-stage development of an investigational cancer vaccine.

3 Aug 2010

Drug Trial News

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

CTI second-quarter total net operating expenses decrease to $20.0 million

ARIAD reports $159.3 million second-quarter net income

Genzyme, Isis announce results of two mipomersen phase 3 studies

Alnylam second-quarter revenues increase to $26.6 million

ImmunoGen fourth-quarter 2010 net loss increases to $13.4 million

Anthera second-quarter total operating expenses increase to $7.9 million

FDA issues Lux Biosciences Complete Response letter for Luveniq NDA

Acceleron's ACE-031 protein therapeutic for DMD receives FDA Fast Track designation

Infinity reports $18.4 million total revenue for second-quarter 2010

NCI panel recommends Celsion's Phase III ThermoDox HEAT Study as Priority Clinical Trial for HCC

Contrave added to diet and exercise regimen can induce significant weight loss

Access Pharmaceuticals initiates Phase I/II dose escalating study for Thiarabine

Advaxis receives India’s DCGI approval for ADXS11-001 Phase II clinical trial for cervical cancer

Glycotope receives German, Italian regulatory approval for CetuGEX Phase I study for solid cancers

CTI files SPA with FDA for new pixantrone phase III trial in relapsed or refractory aggressive B-Cell NHL

ZymoGenetics second-quarter net loss declines to $3.8 million

Excaliard reports positive results from EXC 001 Phase 2 clinical trial for reducing scar severity

Titan completes 60% enrollment in confirmatory Phase 3 clinical study of Probuphine for opioid addiction

Vical second-quarter revenues decrease to $2.1 million

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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