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EMA approves Shire's new REPLAGAL manufacturing facility in Lexington

Shire plc, the global specialty biopharmaceutical company, today announced that the European Medicines Agency has approved the purification of REPLAGAL® (agalsidase alfa) drug substance at its new manufacturing facility in Lexington, MA, US. REPLAGAL, Shire's enzyme replacement therapy for the treatment of Fabry disease is the first product that will be made available to patients from the new facility.

24 Jun 2011

Galileo's advanced visual analytics platform to be launched at BIO 2011 conference

Galileo Analytics announced today that it will debut Galileo Cosmos, Galileo's advanced visual analytics platform at the BIO 2011 conference in Washington, DC, providing a powerful new dimension to Galileo's suite of analytical tools and enhancing the company's ability to mine complex sets of de-identified health data.

24 Jun 2011

PCIB reports main results of Amphinex Phase I/II study against multiple cancers

PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today the main results of the completed Phase I/II study of the new component Amphinex in the combination productPC-A11, where Amphinex is used in combination with the cytotoxic agent bleomycin.

24 Jun 2011

BioMarin to acquire Pfizer's Ireland manufacturing plant

BioMarin Pharmaceutical Inc. announced today that it has entered into a definitive agreement to acquire a bulk biologics manufacturing plant from Pfizer, located in Shanbally, Cork, Ireland.

24 Jun 2011

Scil Technology receives public research grant for novel rheumatoid arthritis treatments

Scil Technology GmbH, a biopharmaceutical company with core expertise in protein drug development, formulation and analytics, today announced that it has been awarded research funding by the German Federal Ministry of Education and Research (BMBF) under BMBF’s KMU-innovativ scheme. The EUR 0.9 million grant supports Scil Technology’s research program to explore the therapeutic potential of repellent proteins for the treatment of rheumatoid arthritis (RA).

23 Jun 2011

FDA grants fast track designation to Synageva for SBC-102 program for Lysosomal Acid Lipase Deficiency

Synageva BioPharma Corp., a privately held biopharmaceutical company developing therapeutic products for rare disorders, announced today that their lead program, SBC-102, an enzyme replacement therapy for Lysosomal Acid Lipase (LAL) Deficiency, currently in clinical trials, has been granted fast track designation by the U.S. Food and Drug Administration (FDA).

23 Jun 2011

Sanofi Pasteur establishes new vaccine research and development facility in Canada

Mark Lievonen, President of Sanofi Pasteur Limited, and Premier Dalton McGuinty today opened a $101 million dollar vaccine research and development facility at Sanofi Pasteur's Connaught Campus in north Toronto. This new facility establishes the Connaught Campus as the North American Centre of Excellence in analytical and bioprocessing R&D for Sanofi Pasteur globally.

23 Jun 2011

Tobira commences cenicriviroc Phase IIb clinical trial for HIV infection

Tobira Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapies for HIV, announced today that it has initiated a Phase IIb clinical trial for the CCR5/CCR2 inhibitor cenicriviroc (TBR-652).

22 Jun 2011

CSL Biotherapies statement on FDA warning letter

Today the US Food and Drug Administration (FDA) published a Warning Letter issued by its Office of Compliance and Biologics Quality to CSL Biotherapies, a division of CSL Limited. The FDA regulates the manufacture, marketing and distribution of CSL Biotherapies’ influenza vaccine, Afluria®, in the US market.

21 Jun 2011

TESARO secures $101M in Series B financing

TESARO, Inc., an oncology-focused biopharmaceutical company, today announced that it has secured $101 million in a Series B financing to advance and expand the Company's cancer product portfolio.

21 Jun 2011

Halozyme to present three data on Ultrafast Insulin programs at ADA 2011

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced three upcoming data presentations for it Ultrafast Insulin programs at the American Diabetes Association (ADA) 71st Scientific Sessions taking place June 24-28, 2011 at the San Diego Convention Center.

21 Jun 2011

Sentrx, TransPerfect collaborate to offer Trial Interactive Portal Technology

TransPerfect and Sentrx have announced a collaboration involving TransPerfect's Trial Interactive Portal Technology, which will streamline end-to-end global drug safety capabilities in both clinical and post-marketing event management.

21 Jun 2011

Panacea Global announces name change

Panacea Global Inc.,, a biopharmaceutical company specializing in blood (protein), serum and tissue tests to diagnose and monitor cancer, today announced the change of the Company's official trading symbol from MLXG to PANG.

20 Jun 2011

Perceptive's Clinical Trial Management System now available as SaaS application

Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation, today announced that its Clinical Trial Management System is available as an on-demand, software-as-a-service (SaaS) application.

From Parexel 20 Jun 2011

Chengdu Tianyin files renewal application for High Tech Enterprise Status

Tianyin Pharmaceutical Co., Inc., a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and active pharmaceutical ingredients today announced that the operating subsidiary of TPI, Chengdu Tianyin Pharmaceutical, has submitted the application for the renewal of its High Tech Enterprise Status at Chengdu, Sichuan Province of China.

20 Jun 2011

RHEI receives Chinese SFDA acceptance letter for MuGard

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, diabetes, and RNAi, announced that its MuGard partner in China, RHEI Pharmaceuticals has received the acceptance letter from the State Food and Drug Administration (SFDA) of China acknowledging all necessary documentation for the MuGard has been submitted and accepted.

17 Jun 2011

Enrollment complete in NeurogesX NGX-1998 Phase 2 clinical study for postherpetic neuralgia

NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced the completion of patient enrollment in its Phase 2 clinical study of NGX-1998, a topical liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN).

16 Jun 2011

Boehringer Ingelheim, Zealand Pharma partner to develop Type-2 diabetes and obesity agonists

Today, Zealand Pharma, a Copenhagen based biopharmaceutical company, and Boehringer Ingelheim, one of the world's leading pharmaceutical companies, jointly announced an exclusive global licence and collaboration agreement for dual-acting glucagon and GLP-1 receptor agonists for the treatment of patients with Type-2 diabetes and patients with obesity.

16 Jun 2011

InNexus files patent protection for new Age-related Macular Degeneration therapeutic

InNexus Biotechnology Inc., a biopharmaceutical company creating and developing innovative solutions for cancer, inflammation and other difficult-to-treat diseases, announced today that it has filed for patent protection covering a novel antibody product for Age-related Macular Degeneration (AMD) and other eye disorders.

16 Jun 2011

Provectus PV-10 Phase 2 trial data on metastatic melanoma to be presented at two conferences

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announces that data from its Phase 2 PV-10 metastatic melanoma study will be presented at two upcoming melanoma conferences.

16 Jun 2011

Biopharmaceutical News and Research

EMA approves Shire's new REPLAGAL manufacturing facility in Lexington

Galileo's advanced visual analytics platform to be launched at BIO 2011 conference

PCIB reports main results of Amphinex Phase I/II study against multiple cancers

BioMarin to acquire Pfizer's Ireland manufacturing plant

Scil Technology receives public research grant for novel rheumatoid arthritis treatments

FDA grants fast track designation to Synageva for SBC-102 program for Lysosomal Acid Lipase Deficiency

Sanofi Pasteur establishes new vaccine research and development facility in Canada

Tobira commences cenicriviroc Phase IIb clinical trial for HIV infection

CSL Biotherapies statement on FDA warning letter

TESARO secures $101M in Series B financing

Halozyme to present three data on Ultrafast Insulin programs at ADA 2011

Sentrx, TransPerfect collaborate to offer Trial Interactive Portal Technology

Panacea Global announces name change

Perceptive's Clinical Trial Management System now available as SaaS application

Chengdu Tianyin files renewal application for High Tech Enterprise Status

RHEI receives Chinese SFDA acceptance letter for MuGard

Enrollment complete in NeurogesX NGX-1998 Phase 2 clinical study for postherpetic neuralgia

Boehringer Ingelheim, Zealand Pharma partner to develop Type-2 diabetes and obesity agonists

InNexus files patent protection for new Age-related Macular Degeneration therapeutic

Provectus PV-10 Phase 2 trial data on metastatic melanoma to be presented at two conferences

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