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New drug could combat cardiovascular disease

A new therapy being studied in non-human primates by researchers at Wake Forest Baptist Medical Center and colleagues is demonstrating promise as a potential tool for combating cardiovascular disease by increasing good cholesterol and lowering triglycerides in the blood.

29 Oct 2011

Covance Shanghai facility receives OECD Good Laboratory Practice certification

Covance Inc. today announced that its early development facility located in Shanghai, China, has received Good Laboratory Practice (GLP) certification from the Belgian GLP Monitoring Authority, a member of the Organization for Economic Cooperation and Development (OECD). The Covance facility in Shanghai provides bioanalytical, toxicology, lead optimization toxicology, in-vivo PK screening, and metabolism services.

24 Oct 2011

Mirna, Silence enter agreement to assess delivery systems for novel microRNAs

Silence Therapeutics plc, a leading RNA interference (RNAi) therapeutics company, today announced that it has entered into an agreement with Mirna Therapeutics Inc., a biopharmaceutical company pioneering microRNA-based therapeutics for cancer, to assess the delivery capabilities of Silence's proprietary AtuPLEX and DBTC delivery systems for Mirna's novel microRNAs.

24 Oct 2011

Positive top line results from Shire's LDX phase III study on ADHD

Shire plc, the global specialty biopharmaceutical company, today presented positive top line results of the first European phase III study of once-daily lisdexamfetamine dimesylate (LDX) in children and adolescents aged 6 to 17 years with Attention-Deficit/Hyperactivity Disorder.

22 Oct 2011

Ipsen, Syntaxin collaborate to develop new botulinum toxins

Ipsen and Syntaxin, a biotechnology company specialising in innovative biopharmaceutical therapies targeting cell secretion pathways, announced today a global strategic collaboration to explore the discovery and development of new compounds in the field of botulinum toxins.

20 Oct 2011

SAIC receives NIAID contract to develop biopharmaceutical products for infectious diseases

Science Applications International Corporation (SAIC) announced today it was awarded a contract by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to provide preclinical services for the development of biopharmaceutical products for infectious diseases.

19 Oct 2011

SomaLogic, Novartis enter multi-year research agreement

SomaLogic, Inc., announced today that it has entered into a multi-year research agreement with Novartis to use its unique proprietary proteomics technology to accelerate Novartis' drug discovery and development efforts.

19 Oct 2011

Commercialization strategies for next-generation medicines

The Center for Biotechnology at Stony Brook University, in collaboration with Demy-Colton Life Science Advisors, and key opinion leaders from the biotech and biopharmaceutical industries, academia, medical research foundations, and investment community, has organized a two-day event to forge partnerships to accelerate the development of new treatments for some of the world's most devastating diseases affecting millions.

18 Oct 2011

FDA approves Oxford BioMedica's UshStat IND to treat Usher syndrome type 1B

Oxford BioMedica plc, the leading gene-based biopharmaceutical company, today announces that the US Food and Drug Administration has approved its Investigational New Drug application for the Phase I/IIa clinical development of UshStat, a novel gene-based treatment for Usher syndrome type 1B.

18 Oct 2011

Positive results from Roche's Phase 3 HannaH trial for HER2-positive early breast cancer

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced that the Phase 3 HannaH trial, conducted by Roche, showed that women with HER2-positive early breast cancer who received a new, investigational subcutaneous (SC) injection of Herceptin (trastuzumab), experienced comparable results to Herceptin given as an intravenous infusion.

18 Oct 2011

Oncobiologics signs two major pharmaceutical agreements

Oncobiologics announced today that it has signed two major agreements. The first is with Parilis Biopharmaceuticals, an early-stage biotech company, and involves worldwide licensing for an undisclosed biotherapeutic product. The second is with a US based large pharmaceutical company to conduct research focused on solving issues related to downstream processing of monoclonal antibodies.

14 Oct 2011

WuXi PharmaTech announces acquisition of Abgent

WuXi PharmaTech Inc., a leading pharmaceutical, biotechnology and medical device research and development services company with operations in China and the United States, today announced the acquisition of Abgent, Inc., a provider of biological research reagent products and services based in Suzhou, China, and San Diego, California.

14 Oct 2011

InnaVirVax announces Phase I/IIa clinical trial authorization for its VAC-3S HIV vaccine

InnaVirVax, a biopharmaceutical company dedicated to the development of therapeutic and diagnostic solutions in pathologies associated with immune dysregulation, declared today that it has obtained authorization from the French drug agency (AFSSAPS) to start a Phase I/IIa clinical study of its therapeutic vaccine VAC-3S for the treatment of HIV infections. This authorization intervenes only two years and half after the launching of InnaVirVax’s activities.

14 Oct 2011

Viewpoints: Screening for prostate cancer, stem cell research and free coverage for Iowa lawmakers

As a practicing internist, I need all the help I can get in diagnosing the many diseases that threaten the life and well-being of my patients. So perhaps you'll understand why I'm angered by the reckless new recommendations from the U.S. Preventive Services Task Force (a panel of primary care experts) that I don't use the prostate-specific antigen to screen men older than 40 for prostate cancer.

13 Oct 2011

Targacept commences AZD3480 Phase 2b study in Alzheimer’s disease

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of a potential registration study of AZD3480 in mild to moderate Alzheimer's disease. The study is the subject of a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration.

10 Oct 2011

Santaris Pharma to report new clinical data from miravirsen Phase 2a study on HCV

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of microRNA and mRNA-targeted therapies, today announced the Company will report new clinical data results from the miravirsen Phase 2a proof-of-concept study to treat patients infected with the Hepatitis C virus (HCV) in a late-breaking oral presentation session at the American Association for the Study of Liver Diseases (AASLD) 2011 annual meeting.

4 Oct 2011

Dosing commences in Auxilium's XIAFLEX phase IIIb trial for Dupuytren's contracture

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the first patients have been dosed in the Company's phase IIIb trial of XIAFLEX® for the treatment of adult Dupuytren's contracture patients with multiple palpable cords.

3 Oct 2011

GeoVax completes enrollment for HIV/AIDS vaccine Phase 2a clinical trial

GeoVax Labs, Inc., an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, announced today the completion of enrollment for a Phase 2a clinical trial testing its HIV/AIDS vaccine.

3 Oct 2011

Regulatory, commercial considerations are the primary drivers for biosimilar development

Regulatory and commercial considerations are the primary drivers for successful biosimilar clinical development, according to a new report from Quintiles, titled An Integrated Approach to Biosimilar Development & Commercialization. In addition, the report states that successful biosimilar companies will be those who collapse their clinical, commercial, and regulatory thinking into a streamlined cohesive function as they proceed with developing biosimilars.

1 Oct 2011

Invida, Sinclair IS launch two dermatology products in seven Asia-Pacific markets

Sinclair IS Pharma Plc, the international specialty pharmaceutical company, and Invida Holdings Private Limited, a leader in the commercialisation of specialty biopharmaceutical and healthcare products throughout Asia Pacific, announce that their partnership has already led to the launch of two Sinclair IS dermatology products in seven Asia-Pacific markets.

30 Sep 2011

Biopharmaceutical News and Research

New drug could combat cardiovascular disease

Covance Shanghai facility receives OECD Good Laboratory Practice certification

Mirna, Silence enter agreement to assess delivery systems for novel microRNAs

Positive top line results from Shire's LDX phase III study on ADHD

Ipsen, Syntaxin collaborate to develop new botulinum toxins

SAIC receives NIAID contract to develop biopharmaceutical products for infectious diseases

SomaLogic, Novartis enter multi-year research agreement

Commercialization strategies for next-generation medicines

FDA approves Oxford BioMedica's UshStat IND to treat Usher syndrome type 1B

Positive results from Roche's Phase 3 HannaH trial for HER2-positive early breast cancer

Oncobiologics signs two major pharmaceutical agreements

WuXi PharmaTech announces acquisition of Abgent

InnaVirVax announces Phase I/IIa clinical trial authorization for its VAC-3S HIV vaccine

Viewpoints: Screening for prostate cancer, stem cell research and free coverage for Iowa lawmakers

Targacept commences AZD3480 Phase 2b study in Alzheimer’s disease

Santaris Pharma to report new clinical data from miravirsen Phase 2a study on HCV

Dosing commences in Auxilium's XIAFLEX phase IIIb trial for Dupuytren's contracture

GeoVax completes enrollment for HIV/AIDS vaccine Phase 2a clinical trial

Regulatory, commercial considerations are the primary drivers for biosimilar development

Invida, Sinclair IS launch two dermatology products in seven Asia-Pacific markets

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