Forbion

CircuLite®, Inc. today announced that it has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE Mark trial of the SYNERGY® IC Circulatory Support System, the first mechanical support system that does not require major surgery. The SYNERGY IC System is based on the surgical SYNERGY® Circulatory Support System – the world’s smallest commercially available circulatory support pump - which is designed to treat ambulatory chronic heart failure patients (INTERMACS ≥4). 

Exosome Diagnostics, a leading developer of biofluid-based molecular diagnostic products for use in personalized medicine research and clinical diagnostics, today announced the presentation of data at the American Urological Association Annual Meeting in San Diego demonstrating the performance of urine exosome technology in accurately predicting the outcom prostate biopsy. James McKiernan, M.D., professor of urology and the director of urologic oncology at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York City presents the da today at 8 a.m. PDT.

Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced the publication of key findings on its proprietary RNA amplification process. The study confirms the Company’s improved RNA amplification techniques enhance the quality of the resultant antigen-specific immune response. 

bluebird bio, a clinical-stage biotechnology company focused on transforming the lives of patients with severe genetic and orphan diseases using gene therapy, today announced that Wendy Dixon, Ph.D., and David Schenkein, M.D., have joined the company’s board of directors.

Exosome Diagnostics, a leading developer of biofluid-based molecular diagnostic tests for use in personalized medicine, today announced that Kapil Dhingra, M.D., has been named chairman of Exosome Diagnostics Board of Directors. 

 arGEN-X, a clinical stage biopharmaceutical company specialized in the discovery and development of highly differentiated human monoclonal antibody therapeutics, announces that it has progressed its second product candidate this year into formal preclinical development.

Pieris AG has achieved the second milestone for the first of two programs in its discovery and development collaboration with Daiichi Sankyo Company Limited (hereinafter Daiichi Sankyo; headquartered in Chuo Ward, Tokyo, TSE 4568), triggering an undisclosed payment, the company announced today. The milestone is based on successful in vitro and in vivo studies validating a range of Anticalin.

Santaris Pharma A/S, a privately held biopharmaceutical company focused on developing medicines targeted to disease-related mRNAs and microRNAs, today announced a worldwide strategic alliance with Bristol-Myers Squibb (NYSE: BMY) to discover and develop novel medicines using Santaris Pharma’s proprietary Locked Nucleic Acid (LNA) Drug Platform.

Exosome Diagnostics, a developer of biofluid-based molecular diagnostic products for use in personalized medicine, today announced data demonstrating exosome technology performance in clinical applications which will be presented at the International Society for Extracellular Vesicles 2013 (ISEV 2013) annual meeting, April 16-20, in Boston. The ISEV meeting is the preeminent international conference in the rapidly growing field of exosome and microvesicle research.

Pieris AG and The Sanofi Group have jointly agreed to expand their ongoing discovery and development partnership to include a novel multispecific Anticalin program. Under the existing framework of the 2010 agreement, the new program will entitle Pieris to an upfront payment from Sanofi and committed research funding as well as payments for the achievement of research, preclinical, regulatory and commercial milestones. Specific financial terms were not disclosed.

Exosome Diagnostics, a leading developer of biofluid-based molecular diagnostics for use in personalized medicine, today announced that the company is presenting a late-breaking abstract at the AACR Annual Meeting 2013, in Washington D.C.  The abstract is titled "Exosome profiling of mRNAs and miRNAs in serum samples from GBM (glioblastoma multiforme) patients." It will be presented during Poster Session 47 from 1 to 5 p.m. EDT on April 8 by Johan Skog, Ph.D., the newly appointed chief scientific officer of Exosome Diagnostics.   

arGEN-X, a clinical stage biopharmaceutical company specialized in the discovery and development of highly differentiated human monoclonal antibody therapeutics, announces that it has progressed ARGX-112, its fourth therapeutic candidate, into formal preclinical development.

bluebird bio, a privately-held biotechnology company focused on gene therapy, today announced the formation of a broad, global strategic collaboration with Celgene Corporation to discover, develop and commercialize novel disease-altering gene therapies in oncology. The collaboration will focus on applying gene therapy technology to genetically modify a patient’s own T-cells, known as chimeric antigen receptor (CAR) T-cells, to target and destroy cancer cells.

Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced the appointment of Jean Lamarre, president of Lamarre Consultants, to its Board of Directors.

Curetis AG today announced

The appointment of Helmut Hilbert as Head of Business Development and

the expansion of its distribution network into Belgium and Luxembourg by

closing a distribution agreement with ELITech BNL (former Lucron

Bioproducts), an ELITech Group company.

CircuLite®, Inc. today announced that it has received conditional approval from the United States Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) for its lead product, the SYNERGY® Circulatory Support System, a minimally-invasive device designed to reverse the symptoms of heart failure in ambulatory chronic heart failure patients.

Dezima Pharma (‘Dezima’), the biotechnology company developing innovative drugs in the field of dyslipidemia, announced today that is has raised a total of €14.2m ($18.6m ) for the clinical development of its cholesteryl ester transfer protein (CETP) inhibitor, DEZ-001(previously TA-8995) and to develop additional earlier-stage dyslipidemia assets.

uniQure has been identified in the field of biomedicine as one of 2013’s 50 Disruptive Companies, MIT Technology Review’s annual list of theworld’s most innovative technology companies. The honorees are nominated by MIT Technology Review’s editors, who look for companies that have demonstrated original and valuable technology over the last year,are bringing that technology to market at significant scale, and are clearly influencing their competitors.Spanning energy and materials, Internet and digital media, computing and communications, biomedicine, and transportation, the 50 companies on the list represent the disruptive innovations most likely to change our lives.

Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced updated results from its Phase 2 study of AGS-003, its most advanced product candidate for the treatment of metastatic renal cell carcinoma (mRCC). The results, presented in a poster session at the 2013 ASCO Genitourinary Cancers Symposium in Orlando, continue to show prolonged survival in patients with unfavorable risk mRCC, with one-third of patients still alive after nearly four years or longer.

Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, announced today its Chief Operating Officer and Vice President of Manufacturing, Dr. Frederick Miesowicz, will present during two focus sessions at Phacilitate's 9th Annual Cell and Gene Therapy Forum on January 28 and 29 in Washington, D.C.

uniQure B.V., the leader in the field of human gene therapy, today announced the appointment of Philip Astley-Sparke, former President and CEO of BioVex, as President US to provide strategic leadership and help build uniQure’s clinical, regulatory, and commercial infrastructure in the US.

Dezima Pharma (‘Dezima’), the biotechnology company developing innovative drugs in the field of dyslipidemia, announced today the inlicensing of a cholesteryl ester transfer protein (CETP) inhibitor DEZ-001 (formerly TA-8995) from Mitsubishi Tanabe Pharma Corporation (MTPC). Terms of the deal were not disclosed.

Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, announced that the first patients have been enrolled in the ADAPT Phase 3 clinical study for AGS-003, its most advanced product candidate. AGS-003 is an investigational, fully personalized, dendritic-cell based immunotherapy. The ADAPT study is designed to examine the potential for AGS-003 plus standard targeted drug therapy to extend overall survival versus standard therapy alone in newly diagnosed patients with unfavorable risk metastatic renal cell carcinoma (mRCC).

 arGEN-X, a biopharmaceutical company specialized in the discovery and development of highly differentiated human monoclonal antibody products, is broadening its therapeutic antibody collaboration with Shire. Initiated in March 2012, the existing alliance is focused on arGEN-X using its SIMPLE Antibody™ discovery platform to create novel human antibody therapeutics addressing diverse rare and unmet diseases being pursued by Shire.

 arGEN-X, a biopharmaceutical company specialized in the discovery and development of highly differentiated human monoclonal antibody therapeutics, announced today the initiation of a Phase Ib first-in-man cancer study with ARGX-110, its first SIMPLE Antibody™ program to enter the clinic in just three years from initiation of discovery.

Promedior, Inc., a clinical stage biotechnology company developing novel biologic therapeutics for the treatment of fibrosis, today announced the opening its new office and laboratory space at 101 Hartwell Avenue, Lexington, Massachusetts.

uniQure B.V., a leader in the field of human gene therapy, today announced a non-exclusive cross-licensing agreement with Benitec Biopharma Ltd. (ASX: BLT) giving uniQure access to Benitec’s proprietary DNA-directed RNA interference (ddRNAi) technology in Huntington’s disease. In return, uniQure granted Benitec non-exclusive access to the Company’s AAV5 delivery technology for the development of a ddRNAi therapy for Hepatitis B.

uniQure B.V., a leader in the field of human gene therapy, today announced the start of its Phase I clinical trial in acute intermittent porphyria (AIP) with the treatment of the first
patient. The study is conducted under the aegis of the AIPGENE consortium, a pan-European collaboration funded in part by the European Commission’s Seventh Framework Program with the aim to develop a gene therapy for the treatment of AIP, a rare and devastating disease caused by mutations in the porphobilinogen deaminase gene(PBGD). AIP can be life-threatening and the long-term effects include irreversible nerve damage, liver cancer and kidney failure. uniQure was granted orphan drug designation for the treatment of AIP in 2009 from the European Medicines Agency.

uniQure B.V., a leader in the field of human gene therapy, today announced the appointment of Hans Christian Rohde as Chief Commercial Officer.

arGEN-X, a biopharmaceutical company focused on the discovery and development of highly differentiated human monoclonal antibody therapeutics has received its first Notice of Allowance from the United States Patent and Trademark Office (USPTO) in connection with a portfolio of patent filings related to its SIMPLE Antibody™ discovery platform.

Curetis AG today announced a strategic supply chain partnership with German family business Horst Scholz GmbH + Co. KG for the production of high-quality plastics parts for its Unyvero Cartridge. Under the agreement, Curetis will invest more than € 2 million in multi-cavity tools for all Unyvero™ Cartridge plastics parts. Curetis has already ordered several multi-cavity tools from Scholz. The first tools will be delivered in early 2013. 

Scholz has been chosen by Curetis due to its unrivalled experience and expertise in medical device-grade injection molding, its state-of-the-art facilities and equipment as well as its cleanroom manufacturing infrastructure.

In a presentation yesterday at the 8th Annual European Antibody Congress in Geneva, Switzerland, Pieris AG presented for the first time data for its PRS-190 bispecific Anticalin program targeting the Th17 pathway. The data revealed the generation of a highly specific and potent bispecific antagonist targeting IL-17 and IL-23, two key members of the Th17 family of cytokines, involved in autoimmunity and hyperinflammation. The single-gene multispecific drug candidate, whose individual building blocks could surpass existing available therapies against their respective target, creates several benefits ranging from efficacy, convenience, accelerated development timelines, ease of manufacturing and cost.

Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced the publication of key findings that confirms the Company’s current methods of analyzing RNA are robust and optimal for the assessment of RNA quality needed to develop the Company’s novel immunotherapies.  The study, which was published in the November issue of the Journal of Pharmaceutical and Biomedical Analysis, the journal of the American Association of Pharmaceutical Scientists, compared traditional slab electrophoresis currently in use at Argos to a newer microfluidics-based platform for performing various RNA analyses.

Exosome Diagnostics today announced it has reached an agreement with Promega Corporation to be the exclusive supplier of its Urine Clinical Sample Concentrator Kit. Promega will manufacture the Clinical Sample Concentrator Kit under current good manufacturing practices (cGMP) in their Madison, Wisconsin manufacturing facility. The kit incorporates Exosome's proprietary method for concentration of urinary exosomes, a standardized approach for providing clinical laboratories access to high quality preparations suitable for molecular diagnostics. The kit will be used to process urine samples for clinical trials in genitourinary disorders, including prostate cancer.

arGEN-X, a biopharmaceutical company focused on the discovery and development of human monoclonal antibodies from its proprietary SIMPLE Antibody™ platform, has strengthened its supervisory board with the appointment of Dr. David L. Lacey.

Dr. Lacey is a former Senior Vice President and Head of Discovery Research at Amgen with over 30 years of basic and clinical research experience. He played a fundamental role in the discovery of the OPG/RANKL/RANK pathway at Amgen as well as the development of the human anti-RANKL mAb denosumab, which was approved in 2010 by the U.S. Food and Drug Administration (FDA) under the trade name Prolia to treat osteoporosis in postmenopausal women and as Xgeva for the prevention of skeletal-related events in metastatic bone tumors. He was most recently responsible for leading more than 1,200 scientists in Amgen's discovery research unit across a portfolio of discovery and preclinical projects in hematology/oncology, inflammation, metabolic disorders and neuroscience.

Curetis AG today announced it has completed enrollment for the European clinical trial of its Unyvero™ Pneumonia Application on schedule. More than 800 patient samples were collected until September 30, 2012. Data analysis will be completed in early 2013. Subsequently, results will be published in a major, peer-reviewed journal.

novoGI Inc. today reported that 21st Century Health and Business, the health and medical related business television program, that showcases insights from cutting edge corporations around the world and innovative business strategies, highlighted novoGI and its compression anastomosis solution and its revolutionary approach to GI disease management. 

Curetis AG today announced the presentation of its UnyveroTM Solution for the rapid molecular diagnosis of infectious diseases and the UnyveroTM P50 Pneumonia Cartridge during the 64th Annual Meeting of the German Society for Hygiene and Microbiology (DGHM) in Hamburg.

Proceeds will Further Strengthen bluebird’s Proprietary Gene Therapy Platform and Advance Multiple Clinical Programs in Severe Genetic Disorders, Including a Global ALD Phase 2/3 Study