Pharmaceuticals News and Research

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SAFC expands fermentation capabilities in Israel facility

SAFC, a member of the Sigma-Aldrich® Group (Nasdaq: SIAL), today announced the completion of its state-of-the-art expansion of its Jerusalem, Israel facility. The additional capacity expands SAFC's contract manufacturing capabilities in large molecule recombinant proteins and small molecule Active Pharmaceutical Ingredients (APIs) through fermentation, including High Potent APIs (HPAPIs) and secondary metabolites.

6 Oct 2010

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

6 Oct 2010

Cancer cells utilize energy-rich intermediates of sugar metabolism: Research

Cancer research is facing a radical change of direction. Cancer cells do not obtain their energy from the breakdown of sugar to carbon dioxide and water, but from energy-rich intermediates of sugar metabolism instead.

6 Oct 2010

Isogenica, NovaBiotics to accelerate the development of peptide anti-infective technology

Isogenica Ltd, today announced that it has entered into a collaboration agreement with NovaBiotics, a leading clinical-stage biotechnology company to fast-track the development of NovaBiotic's platform peptide anti-infective technology.

6 Oct 2010

Tris Pharma receives FDA final approval for generic Tussionex ANDA

Par Pharmaceutical Companies, Inc. today announced that its licensing partner, Tris Pharma, Inc., has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for hydrocodone polistirex and chlorpheniramine polistirex (CIII) extended-release (ER) oral suspension (equivalent to 10 mg of hydrocodone bitartrate and 8 mg of chlorpheniramine maleate per 5 mL).

5 Oct 2010

DATATRAK receives consulting contract to provide clinical data management

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the award of a consulting contract with an existing global research-based biopharmaceutical client to provide clinical data management and trial design services.

5 Oct 2010

Preclinical data of Enzon's PEG-SN38 in pediatric neuroblastoma published in Clinical Cancer Research

Enzon Pharmaceuticals, Inc. today announced the publication of preclinical data demonstrating that PEG-SN38 (EZN-2208), the Company's novel PEGylated DNA topoisomerase I inhibitor, led to significantly greater tumor regression as compared to CPT-11 (irinotecan) in both in vitro and in vivo models of pediatric neuroblastoma.

5 Oct 2010

Intellect Neurosciences receives patent for Alzheimer's disease monoclonal antibody program

Intellect Neurosciences, Inc., a biopharmaceutical company with internal preclinical and clinical-stage pipelines, as well as multiple licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has received a patent from the United States Patent and Trademark Office (USPTO) related to its internal Alzheimer's disease (AD) monoclonal antibody program.

5 Oct 2010

Galapagos honored with 2010 EUROPEAN BIOTECHNICA AWARD

The Belgian biotech company Galapagos has won the 2010 EUROPEAN BIOTECHNICA AWARD. Galapagos thus secures the lion's share of the prize money totalling 75,000 euros, which is offered every year in the competition staged by Deutsche Messe AG and its partners. The award celebrates innovative European companies from the biotechnology sector and the life sciences.

5 Oct 2010

GE Healthcare launches first human cellular assay product

Geron Corporation today announced that GE Healthcare has launched the first human cellular assay product for use in drug discovery and toxicity screening, developed under a license and alliance agreement between the two companies.

5 Oct 2010

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Atazanavir Sulfate Capsules, 150 mg and 300 mg. This product will be eligible for purchase outside the U.S. in certain developing countries.

5 Oct 2010

Reuters, Milwaukee Journal Sentinel honored with Barlett & Steele Awards

Reuters received the gold award and the Milwaukee Journal Sentinel the silver award in the fourth annual Barlett & Steele Awards for Investigative Business Journalism, the Donald W. Reynolds National Center for Business Journalism announced today.

5 Oct 2010

Neuraltus achieves last patient out for NP001, NP002 studies

Neuraltus Pharmaceuticals, a privately held biopharmaceutical company dedicated to developing and commercializing high-impact therapeutics that address critical unmet needs, primarily in the treatment of neurodegenerative diseases, announced today the Company has achieved last patient out in two studies: a Phase 1 clinical study of NP001 in patients with Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease) and a Phase 1/2 clinical study of NP002 in patients with L-dopa-induced dyskinesias (muscle movement disorders).

5 Oct 2010

RHUCIN clinical trial results published in JACI journal

Santarus, Inc., a specialty biopharmaceutical company, today announced the publication of an integrated analysis of two randomized placebo-controlled clinical trials with RHUCIN (recombinant human C1 inhibitor, or rhC1INH), in the October issue of the peer reviewed Journal of Allergy and Clinical Immunology (JACI).

5 Oct 2010

PAREXEL expands presence in Japan with new office in Nagoya

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that the Company has opened a new office in Nagoya, Japan to support a growing demand for a broad range of clinical development and regulatory consulting capabilities in the country and throughout the Asia/Pacific region.

From Parexel 5 Oct 2010

Tasly, ProteoTech to co-develop Exebryl-1(R) medication for Alzheimer's disease treatment

Tasly Pharmaceutical Co., Ltd. and ProteoTech, Inc. today announced an agreement to co-develop ProteoTech's novel small molecule therapeutic, Exebryl-1(R), for the treatment of mild-to-moderate Alzheimer's disease.

5 Oct 2010

BioSante to present LibiGel clinical trial update at NAMS Annual Meeting

BioSante Pharmaceuticals, Inc. today announced that it will present a LibiGel clinical trial update at the 21st Annual Meeting of The North American Menopause Society (NAMS) being held from October 6-9, 2010 at the Sheraton Chicago Hotel & Towers in Chicago, Illinois.

5 Oct 2010

Asterand to supply clinically annotated human biospecimens for The Cancer Genome Atlas project

Asterand plc, a leading provider of human tissue and human tissue-based services to pharmaceutical and biotechnology companies engaged in drug discovery research announced today that it has been awarded a 5-year, up to $24.3 million contract with the National Cancer Institute (NCI) to supply clinically annotated human biospecimens for The Cancer Genome Atlas (TCGA) project.

5 Oct 2010

Researchers call for sustained funding to move HIV vaccine R&D ahead

At the AIDS Vaccine 2010 conference last week in Atlanta, researchers emphasized the need for sustained funding for vaccine research and development in order to further progress toward an HIV vaccine, SciDev.Net reports.

5 Oct 2010

CHI submits comments to FDA CDRH 510(k) Working Group Preliminary Report and Recommendations

California Healthcare Institute today submitted formal comments to the U.S. Food and Drug Administration (FDA) regarding the Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, which could transform the 510(k) regulatory process for new medical devices, greatly affecting innovation and public health in California. CHI is a non-profit public policy research organization, representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms.

5 Oct 2010

Pharmaceuticals News and Research

SAFC expands fermentation capabilities in Israel facility

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Cancer cells utilize energy-rich intermediates of sugar metabolism: Research

Isogenica, NovaBiotics to accelerate the development of peptide anti-infective technology

Tris Pharma receives FDA final approval for generic Tussionex ANDA

DATATRAK receives consulting contract to provide clinical data management

Preclinical data of Enzon's PEG-SN38 in pediatric neuroblastoma published in Clinical Cancer Research

Intellect Neurosciences receives patent for Alzheimer's disease monoclonal antibody program

Galapagos honored with 2010 EUROPEAN BIOTECHNICA AWARD

GE Healthcare launches first human cellular assay product

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Reuters, Milwaukee Journal Sentinel honored with Barlett & Steele Awards

Neuraltus achieves last patient out for NP001, NP002 studies

RHUCIN clinical trial results published in JACI journal

PAREXEL expands presence in Japan with new office in Nagoya

Tasly, ProteoTech to co-develop Exebryl-1(R) medication for Alzheimer's disease treatment

BioSante to present LibiGel clinical trial update at NAMS Annual Meeting

Asterand to supply clinically annotated human biospecimens for The Cancer Genome Atlas project

Researchers call for sustained funding to move HIV vaccine R&D ahead

CHI submits comments to FDA CDRH 510(k) Working Group Preliminary Report and Recommendations

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