Biopharmaceutical News and Research

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Altair Therapeutics initiates its IL-4 receptor alpha inhibitor bronchoprovocation phase 2 trial

Altair Therapeutics, Inc., a privately-held, biopharmaceutical company developing novel therapeutics for respiratory diseases, today announced the commencement of its IL-4 receptor alpha inhibitor bronchoprovocation trial. Study AIR645-CS2 is a phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of inhaled AIR645 in suppressing the asthmatic response in subjects with mild asthma. Results are expected in the third quarter of 2010.

19 Nov 2009

Halifax researcher wins Prix Galien Research Award

Dr. Donald Weaver, a Halifax researcher with unmatched credentials, received the Prix Galien Research Award at a ceremony in Ottawa last night. Known as the Nobel Prize of pharmaceutical research, this award is the highest distinction worldwide for biopharmaceutical work, and the most prestigious in the field of Canadian pharmaceutical research and innovation.

19 Nov 2009

CytRx plans Phase 2 clinical trial of its doxorubicin prodrug for advanced gastric cancer

CytRx Corporation, a biopharmaceutical company, today announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.

18 Nov 2009

New data on Synta Pharmaceuticals' elesclomol presented at the AACR-NCI-EORTC Conference

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today presented new data on the mechanism of action of elesclomol, a first-in-class oxidative stress inducer, at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston, Mass.

18 Nov 2009

Data on Synta Pharmaceuticals' STA-9090 synthetic inhibitor of Hsp90 presented

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that preclinical data presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics shows that STA-9090, a novel, synthetic inhibitor of heat shock protein 90 (Hsp90), demonstrated strong activity in multiple tumor models.

18 Nov 2009

Insights into evolving pharmacovigilance trends and their impact on biosimilars and generic products

Experts from PAREXEL International Corporation, a leading global biopharmaceutical services provider, will provide insights into evolving pharmacovigilance trends and their impact on biosimilars and generic products at the World Generic Medicines Congress Americas, being held November 17 - 20, 2009 in Washington, DC.

From Parexel 18 Nov 2009

Request for pre-IND meeting to discuss IND application for therapeutic vaccine granted by FDA

GeoVax Labs, Inc. (the "Company"), an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced that the U.S. Food and Drug Administration (FDA) has granted its request for a pre-IND meeting to discuss the proposed Investigational New Drug (IND) application for GeoVax's therapeutic vaccine as a treatment for individuals already infected with HIV.

18 Nov 2009

Pre-clinical data of GM1485 to be presented by GliaMed

GliaMed, Inc., a development stage biopharmaceutical company, today announced that Dr. David Weinstein, chief scientific officer and company founder, will present pre-clinical data demonstrating acceleration of wound healing through the in vivo induction and recruitment of stem cells at the Stem Cells USA & Regenerative Medicine Congress in Washington, D.C.

18 Nov 2009

Review of the results of Phase 2b clinical trial on PASCAL announced

ARYx Therapeutics, Inc., a biopharmaceutical company, announced that a review of the results of the Phase 2b clinical trial, PASCAL, testing the efficacy and safety of ARYx’s compound for the treatment of atrial fibrillation, budiodarone, was presented today at the American Heart Association meeting in Orlando, Florida.

18 Nov 2009

Capsugel to have exclusive rights to Appian Labs' AppiForm Modular Release System technology

Appian Labs, LLC, a biopharmaceutical company specializing in advanced therapeutic design and delivery, has announced an exclusive Development and Commercial License Agreement for the company’s AppiForm™ Modular Release System with Capsugel, the world's leading provider of dosage form solutions to the pharmaceutical and related healthcare industries. The agreement provides for Capsugel to utilize the AppiForm Modular Release System for customizable drug delivery profiles.

17 Nov 2009

Melanoma Institute director to present Phase 2 study data of PV-10 for metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that Professor John F. Thompson, MD, Professor of Melanoma and Surgical Oncology at the University of Sydney, Director of the Melanoma Institute Australia, and Lead Investigator of the Phase 2 study of PV-10 for Metastatic Melanoma, will be presenting data at the 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers on November 21, 2009 in Berlin, Germany.

17 Nov 2009

Perceptive Informatics announces the expansion of its medical imaging capabilities for cardiology clinical trials

Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation, today announced that it has expanded its leading medical imaging capabilities with advanced nuclear imaging functionality for cardiology clinical trials.

From Parexel 17 Nov 2009

Shire publishes new study results on INTUNIV Extended-Release Tablets

Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone.

17 Nov 2009

FDA provides feedback on the pending NDA for EXALGO tablets

CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate EXALGOTM (hydromorphone HCl extended release) tablets, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA).

17 Nov 2009

Sequella broadens the licensed therapeutic indications of its SQ109 lead drug candidate

Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat life-threatening infectious diseases, today announced that it amended an existing agreement with the National Institutes of Health (NIH) to significantly broaden the licensed therapeutic indications, or "field of use," for Sequella's lead drug candidate, SQ109.

16 Nov 2009

Additional data from Aegerion Pharmaceuticals' ongoing lomitapide Phase III trial

Aegerion Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of cardiovascular and metabolic disease, today announced additional data from its ongoing Phase III trial involving its lead cholesterol management compound, lomitapide (AEGR-733), which is a microsomal triglyceride transfer protein (MTP) inhibitor small molecule drug.

16 Nov 2009

Onyx Pharmaceuticals acquires Proteolix

Onyx Pharmaceuticals, Inc. today announced that the company has completed its acquisition of Proteolix, Inc., a privately held biopharmaceutical company focused on discovering and developing novel therapies that target the proteasome for the treatment of hematological malignancies and solid tumors.

16 Nov 2009

RXi Pharmaceuticals announces financial results for the quarter ended September 30, 2009

RXi Pharmaceuticals Corporation, a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today reported its financial results for the quarter ended September 30, 2009.

16 Nov 2009

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse-. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

16 Nov 2009

Shire announces findings from Phase 3 study data with Vyvanse

Shire plc, the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

13 Nov 2009

Biopharmaceutical News and Research

Altair Therapeutics initiates its IL-4 receptor alpha inhibitor bronchoprovocation phase 2 trial

Halifax researcher wins Prix Galien Research Award

CytRx plans Phase 2 clinical trial of its doxorubicin prodrug for advanced gastric cancer

New data on Synta Pharmaceuticals' elesclomol presented at the AACR-NCI-EORTC Conference

Data on Synta Pharmaceuticals' STA-9090 synthetic inhibitor of Hsp90 presented

Insights into evolving pharmacovigilance trends and their impact on biosimilars and generic products

Request for pre-IND meeting to discuss IND application for therapeutic vaccine granted by FDA

Pre-clinical data of GM1485 to be presented by GliaMed

Review of the results of Phase 2b clinical trial on PASCAL announced

Capsugel to have exclusive rights to Appian Labs' AppiForm Modular Release System technology

Melanoma Institute director to present Phase 2 study data of PV-10 for metastatic melanoma

Perceptive Informatics announces the expansion of its medical imaging capabilities for cardiology clinical trials

Shire publishes new study results on INTUNIV Extended-Release Tablets

FDA provides feedback on the pending NDA for EXALGO tablets

Sequella broadens the licensed therapeutic indications of its SQ109 lead drug candidate

Additional data from Aegerion Pharmaceuticals' ongoing lomitapide Phase III trial

Onyx Pharmaceuticals acquires Proteolix

RXi Pharmaceuticals announces financial results for the quarter ended September 30, 2009

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

Shire announces findings from Phase 3 study data with Vyvanse

Oxygen Measurement eBook - Easily Understand Dissolved Oxygen Measurement eBook

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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