Abraxis LLC

Warminster, PA, United States

Abraxis LLC

Warminster, PA, United States

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, today announced the appointment of David Brooks, M.D., Ph.D., to Senior Vice President, Clinical Development. Dr. Brooks will be responsible for the execution of Eleven’s ongoing and planned clinical trials. He will report to Arthur DeCillis, M.D., Chief Medical Officer. “Eleven is at a pivotal inflection point, as we progress our Phase 3 registration trial of Vicinium™ and prepare to advance our second program, Proxinium™, into a Phase 1/2a study in combination with a checkpoint inhibitor,” said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. “We are pleased to welcome David to the Eleven team as we continue to build out our clinical development organization. David brings a highly-relevant skillset, including experience overseeing the simultaneous development of multiple oncology programs as monotherapies and in combination with immuno-oncology agents. We look forward to his contributions as we continue to evaluate the potential of our locally- and systemically-administered TPTs and work to bring new medicines that improve upon existing therapeutic options to patients.” Dr. Brooks joins Eleven Biotherapeutics from Deciphera Pharmaceuticals, where he served as Vice President, Clinical Research and Translational Medicine. In this role, Dr. Brooks led the clinical development of four oncology product candidates, set clinical strategy for assets entering testing in direct anti-tumor and immune combination therapy, and planned clinical trials evaluating the combination of immunotherapies with novel myeloid cell checkpoint blockers. Prior to joining Deciphera, Dr. Brooks was Senior Director Physician, Oncology Early Clinical Development at AstraZeneca, where he led the clinical development of a dual specificity PI3K inhibitor across multiple oncology indications and managed a portfolio of external alliances and investigator-sponsored studies. Earlier in his career, Dr. Brooks served as Medical Head, Translational Medicine at TESARO Inc., as Chief Medical Officer and Senior Vice President at Generation Health, Inc., and as Medical Director, Global Clinical Medicine at Abraxis Bioscience, Inc. He also worked at Shire Human Genetic Therapies, Inc. and Merck & Co., Inc. Dr. Brooks holds a M.D. and Ph.D. in Molecular Biology from Cornell University. He completed his residency in Internal Medicine at the University of Pennsylvania and a fellowship in Medical Genetics at the Children’s Hospital of Philadelphia/Hospital of the University of Pennsylvania. He also served as an Instructor in Medicine in the Division of Medical Genetics at the University of Pennsylvania. “I am pleased to join the Eleven team at such an important time,” said Dr. Brooks. “The Company’s lead drug candidates have demonstrated promising anti-tumor activity and safety as single agents. I am eager to work with Eleven’s team to further demonstrate the potential of Vicinium in the clinic. I am particularly excited to progress the ongoing Phase 3 registration trial of Vicinium for patients with high-grade non-muscle invasive bladder cancer, a disease which has not seen meaningful advancements in approximately forty years.” Dr. Brooks is the third recent addition to Eleven’s clinical development group in recent months. In the first quarter, Eleven appointed Gary Conboy as Executive Director, Clinical Sciences and Mary Rohrer as Associate Director, Clinical Operations. Eleven Biotherapeutics, Inc. is a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based upon the Company's TPT platform. The Company's TPTs incorporate a tumor-targeting antibody fragment and a protein cytotoxic payload into a single protein molecule in order to achieve focused tumor cell killing. The Company believes its TPT approach offers significant advantages in treating cancer over existing ADC technologies. The Company believes its TPTs provide effective tumor targeting with broader cancer cell-killing properties than are achievable with small molecule payloads that require tumor cell proliferation and face multi-drug resistance mechanisms. Additionally, the Company believes that its TPT's cancer cell-killing properties promote an anti-tumor immune response that will potentially combine well with immuno-oncology drugs such as checkpoint inhibitors. For more information please refer to the Company's website at www.elevenbio.com. Any statements in this press release about future expectations, plans and prospects for the Company, the Company's strategy, future operations, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the occurrence of any event change or other circumstances that could give rise to the termination of the License Agreement, the uncertainties inherent in receiving future payments pursuant to the License Agreement, the uncertainties inherent in the initiation and conduct of clinical trials, our ability to successfully develop our product candidates and complete our planned clinical programs, our ability to obtain marketing approvals for our product candidates, expectations regarding our ongoing clinical trials, availability and timing of data from clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical studies will be indicative of the results of future studies, the adequacy of any clinical models, expectations regarding regulatory approvals, our ability to obtain, maintain and protect our intellectual property for our technology and products, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the financial performance of the Company, other matters that could affect the availability or commercial potential of the Company's product candidates and other factors discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.


CHANDLER, Ariz.--(BUSINESS WIRE)--On May 12, 2017, Governor Doug Ducey signed Arizona’s $9.8 billion 2018-2019 Budget which provides bonding authority for $1 billion for investments in University Research Infrastructure. This investment continues a collaboration between the State of Arizona, Industry Leaders, Philanthropists, and Arizona’s Universities that is driving Arizona towards its goal of becoming a top-tier bioscience state. The Biotechnology Innovation Organization in partnership with TEConomy Partners publishes the biennial report on the economic impact of the bioscience industry that provides a national overview and ranks the 50 states and Puerto Rico across five quintiles or tiers. The 2016 Report, The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life 2016, was released in June of 2016 at the BIO International Convention in San Francisco. The report includes a wide range of metrics and economic indicators on a national and state basis. As reported in 2016, the top 10 states based on the number of bioscience firms (Tier I) were California, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Pennsylvania, Ohio, and Texas. Could Arizona achieve the growth necessary to reach the top-tiers? Arizona’s leaders began the journey to achieve this goal twenty years ago. In 1997, the Arizona Bioindustry Cluster was founded by Bob Case and Michael E. Berens, Ph.D. laying the foundation for what would become the Arizona Bioindustry Association or AZBio in 2003. Work by the Arizona Legislature and a coalition of community leaders supported voter passage of Proposition 301 in the year 2000. Prop. 301 established a six-tenths of one cent sales tax to support education that included funding for an estimated $1 billion (generated and disbursed over 20 years) for research at Arizona universities. The resulting Technology Research Initiative Fund (TRIF) is administered by the Arizona Board of Regents and has distributed $892 million for the period spanning from 2001-2016 and is well on its way to reach the billion dollar goal by June 30, 2021. The following year, the Flinn Foundation committed to 10 years of major funding for Arizona biosciences and brought together over 100 leaders to begin to craft what would become the Arizona Bioscience Roadmap. Under the stewardship of the Flinn Foundation, the strategic plan for the biosciences in Arizona would include key initiatives along with a commitment to measurement and reporting of the results. The first decade of the new century marked the completion of The Human Genome Project and a new era for life science research and development globally. From 2000 to 2010, Arizona’s Bioscience community activity included the International Genomics Consortium establishing its home in Phoenix and the subsequent creation of the Translational Genomics Research Institute (TGen) which was funded by a $90 million fundraising effort and spun out of IGC. In addition to the funding from Prop. 301, the Arizona legislature approved $440 million for construction of new university research facilities supporting the growth of the Biodesign Institute at Arizona State University, the BIO5 Institute at the University of Arizona, new research facilities at Northern Arizona University and more. An additional $100 million was approved by the voters for bioscience and health care training and facilities at Maricopa Community Colleges. The Virginia G. Piper Charitable Trust committed $50 million to personalized medicine in Arizona and local philanthropists have supported the community with additional resources for research and patient care across the state. Over the last two decades, Arizona’s bioscience industry has focused and grown. Arizona has risen in the rankings to take its place in the second tier of the Bioscience rankings based on number of firms. The Biodesign Institute at Arizona State University has grown from one building to two with a third building under construction. Arizona is now home to the Critical Path Institute, the National Biomarker Development Alliance, the Arizona Alzheimer’s Alliance, the Banner Alzheimer’s Institute, Cancer Treatment Centers of America, and Banner MD Anderson. Barrow Neurological Institute, founded in 1962 as a regional specialty center, has grown into one of the premiere destinations in the world for neurology and neurosurgery. Phoenix Children’s Hospital is now one of the largest children’s hospitals in the country and is ranked in 10 out of 10 specialties. Mayo Clinic has expanded its research and patient care capacity, added proton beam capabilities and will welcome the first class to its Arizona-based Mayo Medical School in 2017. The University of Arizona extended its reach from Tucson to Phoenix which now includes the The University of Arizona College of Medicine-Phoenix and the The University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center on the Phoenix Biomedical Campus. The number of life science companies in Arizona is now over 1,400 and multi-billion dollar exits include the sale of Ventana Medical Systems, Inc. to Roche for $3.4 Billion and Abraxis Biosciences for $2.9 billion to Celgene. Today, companies that were born in Arizona are now publicly traded including Insys, HTG Molecular, and SensTech while others have been acquired by AMAG Pharmaceuticals, Caris Diagnostics, Thermo Fischer, IMS Health, Merz, Stryker and more. These companies have continued to grow in Arizona joining global leaders including BARD, Medtronic, and W.L. Gore. The combined benefits of Arizona’s world-class healthcare institutions and diverse population demographics are driving the number of active clinical trials in the state which have more than doubled over the period from 2012 – 2017 based on data at ClinicalTrials.gov. Long-time residents and new industry partners are benefiting from Arizona’s business-friendly public policy and regulatory environment, affordable operating cost structures, stable and reliable energy suppliers, well-managed water resources, talent, and an affordable cost of living in communities that provide their employees the opportunity for an excellent quality of life. Free from the business disruptions that can be caused by earthquakes, hurricanes, tornadoes, and floods, Arizona has become a go-to site for both high-tech manufacturing and corporate data centers. The Arizona Innovation Challenge, which made its first awards in 2011 and is powered by the Arizona Commerce Authority, awards the most money in the country for a technology commercialization challenge – $3 million ($1.5 million twice yearly) to the world’s most promising technology ventures. Awards range from $100,000 to $250,000 per company. Over this 20-year span, Arizona has gained a reputation as the state with the “collaborative gene” and attracts thought leaders looking to discover, develop, and deliver life-changing and life-saving innovations to patients. Globally recognized thought leaders have left the hallowed halls of Harvard, the National Institutes of Health and other world-class institutions to innovate and collaborate in Arizona. One real-world example of this collaboration is Arizona State University’s International School of Biomedical Diagnostics. A global center for research, teaching and service in the emerging field of biomedical diagnostics, the school pulls expertise from faculty across ASU, in collaboration with Dublin City University (DCU), Ventana Medical Systems, and other industry partners. ASU faculty come from: the Biodesign Institute, College of Health Solutions, Ira A. Fulton Schools of Engineering, School of Life Sciences in the College of Liberal Arts and Sciences, the W. P. Carey School of Business, and the Consortium for Science, Policy & Outcomes. The initiative also leverages the expertise of the National Biomarker Development Alliance that is led by ASU. Under the leadership of President Michael Crow, Arizona State University has been named the Most Innovative University in the United states for two years running and out-ranking Stanford and MIT. Throughout the Arizona Bioscience Roadmap’s first decade, Battelle tracked performance data that was released annually by the Flinn Foundation. The performance metrics released in 2014 serve as the benchmark for the second decade of the Roadmap, with new data reported on a biennial basis. The most current data is available in “2015 Progress of the Biosciences in Arizona,” a report produced by TEConomy Partners (a spinoff of Battelle) that was released in March 2016. The Flinn Foundation will continue to track the progress of the bioscience sector each year by highlighting the state’s major developments. In April of 2017, the Flinn Foundation released its most recent update, the 2016 Progress of the Biosciences in Arizona. Could Arizona achieve the growth necessary to reach the top-tiers? Absolutely. Now, twenty years into the process, Arizona’s Bioindustry has a new funding catalyst. With the Governor’s vision and the Legislature’s support, an additional $1 billion dollars will be invested in university research infrastructure beginning in July of 2018. Arizona’s leaders are already discussing what the next iteration of Prop. 301 will look like as it approaches its renewal on or before 2020. The Arizona Legislature has passed HB2191 which authorizes an additional $10 million in Angel Investor Tax Credits spread over the next four years and SB1416 which continues Arizona’s Quality Jobs Tax Credit, Arizona's Research and Development Tax Credits and other business incentives. Both bills have been sent to the Governor for his signature. Arizona’s leaders are continuing the journey to take the state into the top tiers of the bioscience rankings. The Flinn Foundation has extended its commitment to steward the Arizona Bioscience Roadmap through the year 2025 with the support of the 100-person Arizona Bioscience Roadmap Steering Committee and the Arizona Bioindustry Association (AZBio) Board of Directors is committed to the vision of making Arizona a top-tier bioscience state and works collaboratively to make that vision a reality. A key component in Arizona’s life science ecosystem, the Arizona Bioindustry Association (AZBio) is the only statewide organization exclusively focused on Arizona’s bioscience industry. AZBio membership includes patient advocacy organizations, life science innovators, educators, healthcare partners, municipalities and leading business organizations. AZBio is the statewide affiliate of the Biotechnology Innovation Organization (BIO) and works in partnership with AdvaMed, MDMA, and PhRMA to advance innovation and to ensure that the value delivered from life-changing and life-saving innovation benefits people in Arizona and around the world. For more information visit www.AZBio.org and www.AZBio.TV To learn more about Arizona’s Bioindustry:


News Article | May 30, 2017
Site: www.prnewswire.com

·         Solutions such as nanoformulations with triggered release for tailor-made pharmacokinetics, nanoparticles for local control of tumor in combination with radiotherapy, and functionalized nanoparticles for targeted in-vivo activation of stem cell production are anticipated to drive R&D, consequently resulting in revenue generation in the coming years. ·         Biopharmaceutical and medical devices companies are actively engaged in development of novel products as demonstrated by the increasingly growing partnerships between leading enterprises and nanomedicine startups. ·         Therapeutics accounted for the largest share of market revenue in 2016 owing to presence of nanoemulsions, nanoformulations, or nanodevices ·         These devices possess the ability to cross biological barriers. Moreover, presence of drugs such as Doxil, Abraxane, and Emend is attributive for higher revenue generation ·         Presence of substantial number of products manufactured through the use of microbial sources can be attributed for the largest share ·         In-vitro diagnostics is expected to witness lucrative progress as a result of R&D carried out in this segment ·         Asia Pacific is estimated to witness the fastest growth over the forecast period ·         Key players operating in this industry include Pfizer Inc., Ablynx NV, Nanotherapeutics Inc., Nanoviricides Inc., Abraxis Inc., Arrowhead Research Inc., Celgene Corporation, Bio-Gate AG, and Merck ·         Active expansion strategies are undertaken by a number of the major market entities in order to strengthen their position ·         North America dominated the industry in 2016, accounting for a 42% of total revenue The global nanomedicine market is anticipated to reach USD 350.8 billion by 2025, according to a new report by Grand View Research, Inc. Development of novel nanotechnology-based drugs and therapies is driven by the need to develop therapies that have fewer side effects and that are more cost-effective than traditional therapies, in particular for cancer. Application of nanotechnology-based contrast reagents for diagnosis and monitoring of the effects of drugs on an unprecedented short timescale is also attributive drive growth in the coming years. Additionally, demand for biodegradable implants with longer lifetimes that enable tissue restoration is anticipated to influence demand. As per the WHO factsheet, cancer is found to be one of the major causes of mortality and morbidity worldwide, with approximately 14 million new cases in 2012 and 8.2 million cancer-related deaths. Thus, demand for nanomedicine in order to curb such high incidence rate is expected to boost market progress during the forecast period. Solutions such as nanoformulations with triggered release for tailor-made pharmacokinetics, nanoparticles for local control of tumor in combination with radiotherapy, and functionalized nanoparticles for targeted in-vivo activation of stem cell production are anticipated to drive R&D, consequently resulting in revenue generation in the coming years. Biopharmaceutical and medical devices companies are actively engaged in development of novel products as demonstrated by the increasingly growing partnerships between leading enterprises and nanomedicine startups. For instance, in November 2015, Ablynx and Novo Nordisk signed a global collaboration and a licensing agreement for development and discovery of innovative drugs with multi-specific nanobodies. This strategic partnership is anticipated to rise the net annual sales of the products uplifting the market growth. However, in contrary with the applications of nanotechnology, the entire process of lab to market approval is a tedious and expensive one with stringent regulatory evaluation involved thereby leading investors to remain hesitant for investments. Further key findings from the report suggest: Therapeutics accounted for the largest share of market revenue in 2016 owing to presence of nanoemulsions, nanoformulations, or nanodevices These devices possess the ability to cross biological barriers. Moreover, presence of drugs such as Doxil, Abraxane, and Emend is attributive for higher revenue generation Presence of substantial number of products manufactured through the use of microbial sources can be attributed for the largest share In-vitro diagnostics is expected to witness lucrative progress as a result of R&D carried out in this segment Introduction of nano-enabled biomarkers, vectors and contrast agents with high-specificity and sensitivity are attributive for projected progress Clinical cardiology is expected to witness the fastest growth through to 2025 owing to development in nano-functionalization and modification of surfaces for increased biocompatibility of implants in treatment of late thrombosis Moreover, an abundance of research publications and patent filings from European region with a share of about 25% in nanomedicine-related publications is supportive for revenue generation from European economies Asia Pacific is estimated to witness the fastest growth over the forecast period Factors responsible include government and regulatory authorities that have implemented a framework to encourage R&D collaborations and framework extension. Key players operating in this industry include Pfizer Inc., Ablynx NV, Nanotherapeutics Inc., Nanoviricides Inc., Abraxis Inc., Arrowhead Research Inc., Celgene Corporation, Bio-Gate AG, and Merck Active expansion strategies are undertaken by a number of the major market entities in order to strengthen their position North America dominated the industry in 2016, accounting for a 42% of total revenue Read the full report: http://www.reportlinker.com/p04899216/Nanomedicine-Market-Analysis-By-Products-Therapeutics-Regenerative-Medicine-Diagnostics-By-Application-Clinical-Oncology-Infectious-diseases-By-Nanomolecule-Gold-Silver-Iron-Oxide-Alumina-Segment-Forecasts.html About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. http://www.reportlinker.com __________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nanomedicine-market-is-anticipated-to-reach-usd-3508-billion-by-2025-300465805.html


Baranzoni G.M.,University of Bologna | Fratamico P.M.,U.S. Department of Agriculture | Rubio F.,Abraxis LLC | Glaze T.,Abraxis LLC | And 2 more authors.
International Journal of Food Microbiology | Year: 2014

Shiga toxin-producing Escherichia coli (STEC) strains belonging to serogroup O104 have been associated with sporadic cases of illness and have caused outbreaks associated with milk and sprouts. An outbreak that occurred in Europe in 2011 linked to fenugreek sprouts was caused by E. coli O104:H4 that had characteristics of an enteroaggregative E. coli (EAEC) but carried the gene that encoded for Shiga toxin 2. In this study, methods were developed for detection of this enteroaggregative STEC O104, as well as STEC O104 in sprouts. Multiplex PCR assays for enteroaggregative STEC O104:H4 targeted the stx2, aggR, and wzx104 genes, and for STEC O104 targeted the stx1-2, ehxA, and wzx104 genes. After incubating artificially contaminated sprouts at 4°C for 48h and overnight enrichment in modified buffered peptone water with pyruvate supplemented with three antibiotics (mBPWp), the pathogens were detected in all samples inoculated at a level of ca. 100CFU/25g. Several samples inoculated at lower concentrations of ca. 10CFU/25g were negative by the PCR assays, and this could have been due to cells not surviving or not being able to recover after the stress treatment at 4°C for 48h. For isolation of the pathogens, immunomagnetic separation (IMS) using magnetic beads coated with antibodies against O104 were employed, and this was followed by plating the beads onto mRBA and CHROMagar STEC O104 for isolation of E. coli O104:H4 and mRBA and CHROMagar STEC for isolation of E. coli O104:H7. Presumptive colonies were confirmed by agglutination using latex particles attached to antibodies against serogroup O104 and by the multiplex PCR assays. The methodologies described in this study for detection of enteroaggregative STEC O104:H4 and STEC O104 include the use of IMS and latex reagents for serogroup O104, and they enhance the ability to detect and isolate these pathogens from sprouts and potentially other foods, as well. © 2013 Published by Elsevier B.V.

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