Preclinical News and Research

RSS

Emergent BioSolutions' anthrax monoclonal antibody IND for Phase I study clears FDA review

Emergent BioSolutions Inc. announced today that its Investigational New Drug (IND) application, to commence a Phase I clinical trial for its anthrax monoclonal antibody therapeutic, has cleared U.S. Food and Drug Administration (FDA) review. The Phase I study will evaluate the safety and pharmacokinetics of the company's fully human monoclonal antibody being developed as a parenteral post-exposure therapy for individuals who have symptoms of anthrax disease. In pre-clinical therapeutic studies, Emergent's monoclonal antibody was found to be effective.

17 May 2010

NanoViricides signs Research Agreement with UCSF for testing anti-HIV drug candidates

NanoViricides, Inc., announced that it has signed a Research Agreement with the University of California, San Francisco for testing of its anti-HIV drug candidates. Cheryl Stoddart, PhD, Assistant Professor in the UCSF Division of Experimental Medicine, will be the Principal Investigator.

17 May 2010

Athersys presents data supporting MultiStem programs

Athersys, Inc. today presented data supporting its MultiStem® programs in cardiovascular disease, neurological disease and immune system modulation, and highlighted advancements in other areas, including progress in its drug development program in the area of obesity.

15 May 2010

SANUWAVE Health reports $3.0 million net loss for first-quarter 2010

SANUWAVE Health, Inc.,, an emerging medical technology company focused on regenerative medicine, today reported financial results for the three months ended March 31, 2010 and provided a business update.

14 May 2010

Poorly designed clinical trials adversely affect medical advances

In a paper published this week in Science, experts caution that important ethical issues in the testing of new therapies like stem cells may not be receiving the attention they deserve. Carnegie Mellon University's Dr. Alex John London (Dept. of Philosophy) joined McGill University's Dr. Jonathan Kimmelman (Faculty of Medicine) and University of Wisconsin-Madison's Marina Emborg (Dept. of Medical Physics) to examine the way scientists, physicians, and regulators evaluate risk and benefit when testing new drugs in human beings for the first time.

14 May 2010

Inhibitex reports net loss of $4.8M for first-quarter 2010

Inhibitex, Inc. today announced its financial results for the first quarter ended March 31, 2010. The Company also announced that it has initiated a Phase I single ascending dose trial of INX-189, its lead HCV nucleotide polymerase inhibitor, in healthy volunteers under an Investigational New Drug application with the U.S. Food and Drug Administration.

14 May 2010

GRNCM1 do not cause cardiac arrhythmias after transplantation: Preclinical study

Geron Corporation today reported positive preclinical study data showing that GRNCM1, Geron's cardiomyocyte product derived from human embryonic stem cells, does not cause cardiac arrhythmias after transplantation into a model of chronic heart damage designed to test this potential safety concern.

14 May 2010

Sinovac Biotech's sales for first-quarter 2010 decrease 32% to $4.4M

Sinovac Biotech Ltd., a leading China-based vaccine manufacturer, announced today its unaudited financial results for the three-month period ended March 31, 2010.

14 May 2010

Chimerix commences first-in-human study of CMX157 for HIV

Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced the commencement of a first-in-human study of CMX157, a novel lipid conjugate of the nucleotide tenofovir with in vitro activity against both tenofovir-sensitive and tenofovir-resistant human immunodeficiency virus (HIV). CMX157 has the potential to increase efficacy and decrease toxicity as compared to tenofovir, and may enable the creation of new 'one pill, once-a-day', fixed-dose combination regimens for the treatment of HIV infection.

14 May 2010

Repligen files IND for Phase 1 study of RG2833 selective HDAC-3 inhibitor for Friedreich's ataxia

Repligen Corporation announced today that it has filed an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) for a Phase 1 study of RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor. This is a double-blind, single ascending dose, Phase 1 study in healthy volunteers to evaluate the pharmacokinetic and safety profile of RG2833 in up to 40 subjects.

13 May 2010

Researchers provide better understanding of anti-cell death proteins and potential antagonist to defeat them

Cancer uses devious means to evade treatment and survive. One prime example is the way tumors express anti-cell death (anti-apoptotic) proteins to resist chemotherapy and radiation. However, the Pellecchia laboratory at Sanford-Burnham Medical Research Institute has made two recent discoveries that may help curb these anti-apoptotic proteins and make current treatments more effective.

13 May 2010

Aeterna Zentaris posts net loss of $5.9 million for first-quarter 2010

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrinology, today reported financial and operating results as at and for the three months ended March 31, 2010.

13 May 2010

ACHN reports net loss of $5.6M for first-quarter 2010: MicroStockProfit.com

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

13 May 2010

pSivida reports consolidated net loss of $2.7 million for third-quarter 2010

pSivida Corp., a drug delivery company with two of the only three ophthalmic sustained release delivery products approved by the FDA for treatment of back-of-the-eye diseases, today announced financial results for its third quarter and nine months ended March 31, 2010.

13 May 2010

NovaBay first-quarter net loss increases to $1.6 million

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, today reported financial results for the first quarter of 2010.

12 May 2010

Pro-Pharmaceuticals reports net loss applicable to common stock of $2.8M for first-quarter 2010

Pro-Pharmaceuticals, Inc., a developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today reported its financial results for the first quarter, ended March 31, 2010.

12 May 2010

Key mechanisms for delivery of LNP-encapsulated siRNAs to the liver

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today the publication of pre-clinical research in the journal Molecular Therapy revealing key mechanisms related to the systemic delivery of RNAi therapeutics using lipid nanoparticles (LNPs).

12 May 2010

Evotec first-quarter operating loss decreases 93% to € 1.5 m

Evotec AG today reported financial results and corporate updates for the first quarter of 2010.

12 May 2010

COTI announces favourable independent pre-IND gap analysis report for novel oncology drug candidate

Critical Outcome Technologies Inc. announced today that it received a favourable Pre-Investigational New Drug (pre-IND) gap analysis report from an independent team that reviewed its novel oncology drug candidate COTI-2. This represents an important milestone as the Company draws closer to a Phase 1 clinical trial.

12 May 2010

NiKem Research receives Italian authorization to perform toxicology studies of NCEs in rodents

NiKem Research is pleased to announce that it has received on March 29th 2010, from the Italian Ministry of Health (Decree N. 69/2010-B), the authorization to perform acute and sub-chronic toxicology studies (upto 28 days) in all rodent species for preliminary safety evaluation of novel chemical entities (NCEs). Toxicokinetic (TK) studies are also allowed to correlate plasma and/or organ exposure of NCEs (and metabolites) to tolerated doses in toxicology studies.

12 May 2010

Preclinical News and Research

Emergent BioSolutions' anthrax monoclonal antibody IND for Phase I study clears FDA review

NanoViricides signs Research Agreement with UCSF for testing anti-HIV drug candidates

Athersys presents data supporting MultiStem programs

SANUWAVE Health reports $3.0 million net loss for first-quarter 2010

Poorly designed clinical trials adversely affect medical advances

Inhibitex reports net loss of $4.8M for first-quarter 2010

GRNCM1 do not cause cardiac arrhythmias after transplantation: Preclinical study

Sinovac Biotech's sales for first-quarter 2010 decrease 32% to $4.4M

Chimerix commences first-in-human study of CMX157 for HIV

Repligen files IND for Phase 1 study of RG2833 selective HDAC-3 inhibitor for Friedreich's ataxia

Researchers provide better understanding of anti-cell death proteins and potential antagonist to defeat them

Aeterna Zentaris posts net loss of $5.9 million for first-quarter 2010

ACHN reports net loss of $5.6M for first-quarter 2010: MicroStockProfit.com

pSivida reports consolidated net loss of $2.7 million for third-quarter 2010

NovaBay first-quarter net loss increases to $1.6 million

Pro-Pharmaceuticals reports net loss applicable to common stock of $2.8M for first-quarter 2010

Key mechanisms for delivery of LNP-encapsulated siRNAs to the liver

Evotec first-quarter operating loss decreases 93% to € 1.5 m

COTI announces favourable independent pre-IND gap analysis report for novel oncology drug candidate

NiKem Research receives Italian authorization to perform toxicology studies of NCEs in rodents

Event guide: 4th LNP Formulation & Process Development Summit eBook

Latest eBooks

Industry Focus eBook - Analytical Chemistry (3rd edition)

Industry Focus eBook - Microbiome (1st edition)

Industry Focus eBook - Cell biology (5th edition)

Advancing degrader and proximity-based drug development

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics