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ISPE Plan To Prevent Drug Shortages Released At Annual Meeting

October 15, 2014 – 5:00 am | Edit Post

TAMPA, Fla., Oct. 15, 2014 /PRNewswire-USNewswire/ — ISPE, the International Society for Pharmaceutical Engineering, released its Drug Shortages Prevention Plan at its 2014 Annual Meeting in Las Vegas, Nevada. Regulators from the European Medicines Agency (EMA), the US…

KLAS Clinical Decision Support Report Ranks Zynx Health No. 1 in Overall Performance

October 15, 2014 – 5:00 am | Edit Post

LOS ANGELES, Oct. 15, 2014 /PRNewswire/ –ZynxCare emerged as the top-ranked solution for overall performance in the plans of care category, according to the results of the recently released KLAS report, “CDS Order Sets and Care Plans 2014: Choosing the Best Option.”

Orexigen Therapeutics, Inc. Pockets $100 Million Milestone Payment From Takeda Pharmaceutical Co. Ltd.

October 15, 2014 – 5:00 am | Edit Post

Milestone Payments Earned by Orexigen Total $100 Million as Contrave (naltrexone HCI and bupropion HCI extended release) is Shipped to Wholesalers in Preparation for Commercial LaunchSAN DIEGO, Oct. 15, 2014 /PRNewswire/ — Orexigen Therapeutics, Inc. (Nasdaq:OREX) today announced…

Announcement Regarding Submission Of Tender Offer For Shares In Ambit Biosciences

October 15, 2014 – 5:00 am | Edit Post

TOKYO and SAN DIEGO, Oct. 14, 2014 /PRNewswire/ –On Friday October 10, U.S. Eastern Time, Daiichi Sankyo Company, Limited (hereinafter, Daiichi Sankyo) (TSE: 4568), through its wholly-owned U.S. subsidiary, Charge Acquisition Corp., launched a tender…

San Diego’s Ebola-fighting efforts expand

October 14, 2014 – 10:20 pm | Edit Post

Yet another Ebola-fighting product has emerged from San Diego, a blood purifier.

San Diego’s Ebola-fighting efforts expand

October 14, 2014 – 10:20 pm | Edit Post

Yet another Ebola-fighting product has emerged from San Diego, a blood purifier.

DNAtrix Completes $20 Million Series B Financing

October 14, 2014 – 6:00 am | Edit Post

SAN DIEGO, Oct. 14, 2014 /PRNewswire/ — DNAtrix, a clinical-stage oncolytic immunotherapy company, announced that it has completed a $20M Series B equity financing.  New investor Morningside Ventures led the round and was joined by existing investors including Mercury Fund, Targeted Technology Fund and others.  Ms. Reenie McCarthy has joined the DNAtrix Board of Directors for Morningside.

“Securing this funding is a significant milestone that will enable us to advance our lead oncolytic virus product, DNX-2401, into late stage clinical trials for glioblastoma,” said Frank Tufaro, Ph.D., president and chief executive officer of DNAtrix.  “We have encouraging results from four completed and ongoing clinical studies, and this over-subscribed funding round validates our data-driven clinical approach.”  DNAtrix previously reported the outcome of a Phase 1 clinical study of DNX-2401 in 37 recurrent glioblastoma patients that showed durable tumor responses and long- term benefit in a significant subset of patients.

“We are pleased to work with DNAtrix to address this critical need,” said Reenie McCarthy, for Morningside.  “As long-time believers in the potential of oncolytics, we are gratified to see this promising treatment progress for this unmet medical need.” 

About Morningside Morningside is a diversified investment group founded in 1986 by the Chan family of Hong Kong. It is engaged primarily in private equity and venture capital investments. The group has investments in North America, Europe, across Asia-Pacific, and since 1992, in Mainland China. Morningside is an active investor in early-stage life science companies formed around new technologies that represent a high degree of novelty over existing technologies. More information is available at www.morningside.com.

About Mercury Fund, Inc. Mercury Fund is a seed-stage venture capital firm that makes equity investments in compelling and novel software and science-based startup opportunities. Since inception in 2005, Mercury Fund has become one of the most active seed-stage venture firms in the Midcontinent.

About DNAtrix, Inc. DNAtrix is a company developing modified viruses for the treatment of the most aggressive forms of cancer. Since viruses are already efficient at killing cells, scientists have harnessed this ability by modifying a common cold virus so that it targets and selectively kills cancer cells. DNAtrix is a privately held company located in Houston, Texas and San Diego, California. For more information, please visit the Company’s website at http://www.dnatrix.com.

Contact: Frank Tufaro, Ph.D. Chief Executive Officer ftufaro@dnatrix.com 
SOURCE DNAtrix, Inc.

BioAtla Receives Broad Patent For Antibody Development

October 14, 2014 – 5:30 am | Edit Post

SAN DIEGO, Oct. 14, 2014 /PRNewswire/ – BioAtla, a global biotechnology company focused on the development of Conditionally Active Biologics (CABs), today announced that the United States Patent and Trademark Office (USPTO) has issued to BioAtla U.S. Patent No. 8,859,467, for its proprietary Comprehensive Integrated Antibody Optimization™ (CIAO!™) technology platform. The BioAtla CIAO patent broadly covers methods of evolving and screening for antibodies in manufacturing host cells during the discovery stages of drug development. The CIAO technology platform allows for antibody candidate development in a native cellular environment that generates the best collection of lead candidates that optimize downstream expression yields and in vivo translation of function, thereby increasing the likelihood of preserving selected therapeutic activities in the final drug.

“CIAO and our related proprietary evolution and selection technologies are beneficial, and often critical, in the development of antibodies and other proteins that maximize selectivity, such as those developed from our patented CAB technology,” said Jay M. Short, Ph.D., president, chief executive officer and chairman of the board of BioAtla. “CABs can be designed as monoclonal antibodies, antibody drug conjugates (ADCs), CAR-T cells or other therapeutics to target specific tissues in cancerous or distressed conditions associated with unique microenvironments in the body. CAB antibodies are a disruptive technology for the development of a powerful new class of immunotherapeutics and are prime examples of novel potential product opportunities that benefit from the use of CIAO-based processes.”

BioAtla employs CIAO technology in all of its internal development programs for its growing list of pipeline antibody candidates. The high fidelity of the CIAO platform when combined with BioAtla’s evolution technologies allows selection of therapeutic candidates with unique functional characteristics, natural protein folding and glycosylation, high protein expression and faster downstream process development characteristics, all of which enable cost and time efficiencies, as well as maximizing and preserving functionality. This homogenous process of evolution through manufacturing leads to greater predictability and likelihood of therapeutic success. BioAtla has successfully utilized CIAO in dozens of antibody programs it has conducted for biotechnology companies and research institutions over the past several years including the licensing in early 2014 of an antibody directed at a novel validated target for the treatment of inflammatory bowel diseases (IBD) and colorectal cancer.

About the CIAO! Technology Platform The development of novel therapeutic antibodies is increasingly employing the power of evolution to discover molecules with selected characteristics. A molecule’s characteristics reflect all inherent and environmental influences such as amino acid sequence, secondary modifications (e.g. glycosylation), and tertiary characteristics such as folding which is affected by environmental factors including pH, salt, temperature, hydrophobicity, support proteins (e.g. chaperonins), substrate pools; generically, the host environment. While the power of evolution is the ability to discover molecules with selected characteristics, the inherent challenge is that the selection process is dominated by the selection environment or assay. As an example, selecting a molecule in bacteria and subsequently expressing in mammalian cells risks generating molecules that require extra process development costs to adapt to the different host system and poor pK in vivo due to the potential of selecting unnatural secondary and tertiary structures. The power of BioAtla’s CIAO technology is that it selects molecules in a manner that mirrors both the body’s environment and the host that will be used for final manufacturing of the drug.

About Conditionally Active Biologics (CABs)Conditionally Active Biologic proteins (CABs) are generated using BioAtla’s proprietary protein evolution technologies, including CIAO, that typically employ selected amino acid substitutions in a protein that work together to confer selective conditional activation found in a range of microenvironments existing in the body. These proteins can be monoclonal antibodies (mAbs), antibody drug conjugates, CAR-T cells, or other therapeutic proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof).

CABs allow for higher dosing or the development of more potent, non-immunogenic drugs. CABs increase safety because the drug is activated and preferentially binds directly to its intended target protein in the microenvironment of the diseased cells and not in normal tissue.  This advantage allows CABs to use targets that are present on cancer cells even though the targets may also be prevalent among normal cells. Such targets are considered unusable in current drug therapy approaches because their lack of selectivity risks unwanted on-target toxicity. The higher selectivity resulting from CAB antibody generation is expected to capitalize on the attractiveness of such previously unavailable targets and increase the effectiveness of most therapeutics relative to traditional antibody approaches.

About BioAtla, LLCBioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic products with more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing. By utilizing its proprietary technologies of product design and development, from target discovery to manufacturing and preclinical studies, BioAtla develops differentiated, patentable therapeutic proteins for its partners and for its internal programs. BioAtla has over 70 patents issued and pending that cover its platform technologies representing a full complement of therapeutic protein development capabilities. Learn more at www.bioatla.com.
SOURCE BioAtla

ArtVentive Medical Group, Inc. Announces Expanded Commercial Use and Post-Market Study of EOS(TM) Endoluminal Occlusion System

October 14, 2014 – 5:15 am | Edit Post

CARLSBAD, CA–(Marketwired – Oct 14, 2014) – ArtVentive Medical Group, Inc. ( OTCBB : AVTD ) announced today additional excellent clinical results in the ongoing ArtVentive EOST Endoluminal Occlusion System, or ArtVentive EOST, OCCLUDE I post-market surveillance study.

Cypher Genomics Forms Scientific Advisory Board to Advance Genome Interpretation and Biomarker Discovery Services

October 14, 2014 – 5:00 am | Edit Post

SAN DIEGO, Oct. 14, 2014 /PRNewswire/ – Cypher Genomics, Inc., the genome informatics company, announced today the formation of a scientific advisory board (SAB) to guide the development and implementation of Cypher’s products, which include MantisTM, the genome interpretation software as a service offering, and CoralTM, a biomarker discovery service. Drs. Kelly Bethel, Michael Hultner, Myla Lai-Goldman, Arnold (Arnie) Levine and Diego Miralles have joined as members of the SAB, alongside Dr. Nicholas Schork, who co-founded Cypher Genomics and is the SAB’s chair. Designed for pharmaceutical companies, clinical laboratories and to support population genomics efforts, Cypher’s fast, accurate and robust genome interpretation and analysis technologies facilitate differentiated molecular tests, efficient clinical trials and enable precision therapeutic decisions. 

“Cypher has gathered an exceptional team of scientific advisors who each bring distinctive skill sets to the board. Drs. Bethel and Lai-Goldman are physicians that have routinely utilized genomic information in their medical practices and at leading diagnostic companies, respectively. Dr. Hultner innovates at the interface of technology and healthcare with a focus on population genomics and Dr. Miralles focuses on emerging technologies with applicability to pharmaceutical companies,” said Ali Torkamani, PhD., the company’s co-founder and chief scientific officer. “With his co-discovery of the p53 tumor suppressor gene, Dr. Levine is renowned as a pioneer in cancer research and genomics. We look forward to working with these thought leaders to advance Cypher’s genome interpretation technology to find clinically meaningful information in human sequencing data to improve healthcare.”

“The identification and confirmation of a gene that is associated or linked to a disease requires a diverse and experienced team and previously necessitated years and even decades of research,” said Levine. “I look forward to working with Drs. Bethel, Hultner, Lai-Goldman, Miralles and Schork to advance Cypher’s technology for the discovery of the genetic basis of complex diseases and traits, to better diagnose patients, understand drug response and, ultimately, deliver on personalized medicine.”

Kelly Bethel, M.D., is a practicing hematopathologist in the Scripps Clinic Medical Group and holds an adjunct appointment at The Scripps Research Institute. In addition to her clinical practice, she is the medical director of the Blood Bank at Scripps Clinic and Green Hospital, the past program director of the Scripps Hematopathology Fellowship, and participates in various translational research activities investigating circulating tumor cells, anemia, low-grade B-cell malignancies and myelodysplasia. She completed an internship in pediatrics, a residency in anatomic and clinical pathology, and subspecialty training in hematopathology at the Naval Medical Center San Diego. She received her B.A. in English literature from Yale University and her M.D. from George Washington University School of Medicine and Health Sciences. Dr. Bethel is board certified in anatomic and clinical pathology and hematopathology.

Michael Hultner, Ph.D. is chief scientist for Lockheed Martin’s Health and Life Sciences (HLS) division where he promotes technical and business innovations to position HLS for future new business in healthcare IT. He currently manages a diverse portfolio of healthcare innovations including big data analytics, population-scale genomics, and synthetic biology. As a Lockheed Martin Fellow, Dr. Hultner supports corporate engineering and technology with subject matter expertise, strategy, and business development in advanced information fusion, machine learning, software development, and program management. Dr. Hultner received his Ph.D. in biomedical sciences from the University of California, San Francisco and an undergraduate degree in molecular biology from University of California, San Diego.

Myla Lai-Goldman, M.D. is the chief executive officer and a founder of GeneCentric Diagnostics. Dr. Lai-Goldman spent more than 18 years at Laboratory Corporation of America Holdings (LabCorp), with the last 10 years as executive vice president, chief medical officer and chief scientific officer. During her tenure at LabCorp, she led all clinical, scientific and medical activities, including the introduction of more than 400 clinical assays. After leaving LabCorp, she became a venture partner at Hatteras Venture Partners. Dr. Lai-Goldman received her M.D. from Columbia University College of Physicians and Surgeons and is board certified in anatomic and clinical pathology.

Arnold Levine, Ph.D. is a pioneering cancer research scientist, having discovered the p53 tumor suppressor protein in 1979. He established the Simons Center for Systems Biology at the Institute for Advanced Study, which concentrates on research at the interface of molecular biology and the physical sciences in cancer biology. Dr. Levine was previously president of The Rockefeller University, and prior to that he was the Harry C. Wiess Professor in Life Sciences and former chairman of the Department of Molecular Biology at Princeton University. He is a member of the National Academy of Sciences and serves on a number of cancer center scientific advisory boards. Dr. Levine holds a Ph.D. in microbiology from the University of Pennsylvania and a B.A. from Harpur College, State University of New York at Binghamton.

Diego Miralles, M.D. is Global Head of Innovation, Janssen and leads a multi-disciplinary group focused on enhancing the value of the pharmaceutical business by identifying and integrating emerging technologies and novel partnerships in areas including genomics and clinical trials. In addition, Dr. Miralles is the management sponsor of Janssen Labs and site head of the Janssen West Coast Research Center, part of Janssen Research & Development LLC where he oversees the business and operational management of Janssen Labs including the initial concept development, site construction, business model architecting and company selection criteria. He graduated from the University of Buenos Aires and completed his residency in internal medicine at the Mayo Clinic in Rochester, Minn. followed by a fellowship in infectious diseases at Cornell University and New York Hospital. 

Nicholas Schork, Ph.D. is a co-founder of Cypher Genomics and chair of Cypher’s SAB. Dr. Schork is a world-expert in quantitative and integrated human genetics and genomics, particularly the design and implementation of methodologies to dissect the genetic basis of complex traits and diseases and is the lead inventor of Cypher Genomics’ biomarker discovery technology. He is professor and director of Human Biology at the J. Craig Venter Institute and the head of Integrated Genomics at Human Longevity, Inc. Dr. Schork has published more than 425 scientific articles and book chapters on the analysis of complex, multifactorial traits and diseases. 

About Cypher Genomics

Cypher Genomics is a leading genome informatics company offering a highly accurate, rapid and robust interpretation software solution for users of human genome sequencing. The proprietary, automated genomic interpretation platform allows clinical laboratories to tune Cypher Genomics’ market leading sensitivity and specificity profiles to develop molecular tests for diagnostic and prognostic use and pharmaceutical companies to discover biomarkers from whole genome sequence data in sample sizes typical of early stage drug development studies. Through MantisTM, the genome interpretation software as a service offering, and CoralTM, a biomarker discovery service, Cypher Genomics can improve health care and reduce costs by facilitating improved diagnostic accuracy and earlier interventions, optimizing therapeutic approaches and reducing adverse drug reactions. Cypher Genomics is located in San Diego, California.

For more information about Cypher Genomics, visit www.cyphergenomics.com and follow us on Twitter @cyphergenomics.
SOURCE Cypher Genomics, Inc.