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Zalicus commences Synavive SYNERGY Phase 2b clinical trial for rheumatoid arthritis

Zalicus Inc. a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced the initiation of the SYNERGY trial, a Phase 2b clinical trial evaluating Synavive, a low-dose glucocorticoid with the potential for amplified immuno-inflammatory benefits, in patients with rheumatoid arthritis (RA).

29 Jun 2011

Nimbus Discovery closes $24 million Series A financing

Nimbus Discovery LLC, a biopharmaceutical company using state-of-the-art computational technology to discover novel medicines against exciting but previously inaccessible disease targets, today announced the close of a $24M Series A financing.

28 Jun 2011

BioLineRx initiates enrollment in BL-1020 Phase II/III trial against schizophrenia

BioLineRx, a biopharmaceutical development company, announced today the enrollment of the first patient in the Phase II/III CLARITY clinical trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia.

28 Jun 2011

DSM introduces Kremer Method for rapid, cost effective production of biopharmaceuticals

Royal DSM, the global Life Sciences and Materials Sciences company, today announced the introduction of the Kremer Method, an innovative proprietary technology developed by DSM scientists which improves downstream processing of monoclonal antibodies (mAbs) for faster and more cost effective production of biopharmaceuticals

28 Jun 2011

Microbix renegotiates key terms of Hunan influenza vaccine joint venture

Microbix Biosystems Inc., a biotechnology company commercializing novel technologies for influenza vaccine manufacturing and biological products announced today that it is renegotiating key terms of the original joint venture agreement with their Joint Venture partner Hunan Biopharmaceutical Co. Ltd.

28 Jun 2011

Circulation journal publishes Celladon's MYDICAR Phase 2 trial on advanced heart failure

Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announces that the data from its completed Phase 2 CUPID clinical study of MYDICAR for the treatment of advanced heart failure is being published today online in Circulation, an American Heart Association journal.

28 Jun 2011

Nile completes dosing in Part B of cenderitide Phase I study for ADHF

Nile Therapeutics, Inc., a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced that it has completed dosing the first patient in Part B of the ongoing Phase I study.

27 Jun 2011

Yissum, BioLineRx sign license deal to develop and commercialize BL-7040 for IBD

BioLineRx, a biopharmaceutical drug development company, and Yissum Research Development Company Ltd., the Technology Transfer Company of the Hebrew University of Jerusalem, announced today that they have signed a worldwide, exclusive license agreement for BioLineRx to develop and commercialize BL-7040, an orally available Phase II ready molecule for treating Inflammatory Bowel Disease (IBD) and other inflammatory diseases.

27 Jun 2011

Positive results from Stealth's Bendavia Phase I renal impairment study

Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative mitochondrial therapies, announced today the results of a Phase I renal impairment study with Bendavia.

27 Jun 2011

FDA approves Laureate's Electronic Submission Gateway application

Laureate Biopharmaceutical Services, Inc. announced today that the U.S. Food and Drug Administration ("FDA") approved its application for an Electronic Submissions Gateway (ESG) to the Agency.

24 Jun 2011

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

Biopharmaceutical News and Research

Zalicus commences Synavive SYNERGY Phase 2b clinical trial for rheumatoid arthritis

Nimbus Discovery closes $24 million Series A financing

BioLineRx initiates enrollment in BL-1020 Phase II/III trial against schizophrenia

DSM introduces Kremer Method for rapid, cost effective production of biopharmaceuticals

Microbix renegotiates key terms of Hunan influenza vaccine joint venture

Circulation journal publishes Celladon's MYDICAR Phase 2 trial on advanced heart failure

Nile completes dosing in Part B of cenderitide Phase I study for ADHF

Yissum, BioLineRx sign license deal to develop and commercialize BL-7040 for IBD

Positive results from Stealth's Bendavia Phase I renal impairment study

FDA approves Laureate's Electronic Submission Gateway application

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

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