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Neuroblastoma is the second most common solid tumour in childhood, following brain tumours[2], and predominantly affects children under five years old[3]. Every year in Europe, around 1,200 children are diagnosed with neuroblastoma[4], a rare cancer arising from neural crest cells, which are involved in the foetal development of the nervous system and other tissues.[2] Because neuroblastoma can spread very quickly, almost half of children are initially diagnosed at an advanced stage of their disease and are recognised as 'high-risk' and with a poor prognosis. Approval of dinutuximab beta brings new hope to these 'high-risk' children who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as those with history of relapsed or refractory neuroblastoma, with or without residual disease.[1] "Today's announcement is a leap forward for the children and families affected by neuroblastoma, particularly those who have keenly followed the positive clinical trial results for dinutuximab beta and long anticipated its approval in Europe," commented Dr Juliet Gray, Associate Professor and Consultant in Paediatric Oncology at University of Southampton, UK. "As a clinician working in a highly specialised disease area with limited treatment options, I greatly welcome the availability of this targeted immunotherapy treatment that offers improved results for high-risk neuroblastoma patients used alone or in combination with existing therapies." Steve Richards, CEO of the neuroblastoma charity Solving Kids' Cancer Europe, added: "In the absence of any other targeted immunotherapy for children with high-risk neuroblastoma, the European regulatory body that approves medicines to be marketed in Europe, expedited the review of dinutuximab beta. Today's approval means that EUSA Pharma who manufactures dinutuximab beta is able to make it available for use by hospitals across Europe, improving access for thousands of children and their families to this new treatment, with proven improved survival rates. The next challenge will be for EUSA Pharma to engage with relevant access bodies throughout Europe, including NICE in the UK, to ensure timely review through the new drugs processes and secure access to this medicine for patients. The young innocent victims of this cruel and devastating disease deserve nothing less." Lee Morley, CEO of EUSA Pharma, commented, "We are delighted that the EC has recognised the urgent need to accelerate approval of dinutuximab beta in order to provide an effective and targeted treatment for this debilitating disease. EUSA Pharma in partnership with Apeiron and SIOPEN has believed strongly in the potential of this treatment throughout the clinical trial process and today's announcement is final acknowledgement of its value to address the serious unmet need of children and their families affected by high-risk neuroblastoma." Dinutuximab beta is a monoclonal chimeric antibody developed to target a specific antigen, GD2, on neuroblastoma cells. It has been investigated in clinical trials for high-risk neuroblastoma, with more than 1000 patients having received treatment to date. Dinutuximab beta has orphan drug designation in the US and EU, and EUSA plans to file the product for approval in the United States in 2017. Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company with commercial operations across Europe and the USA, and a wider distribution network in approximately 40 further countries. The management team comprises highly experienced pharmaceutical professionals with a broad experience and proven track record of successfully identifying, developing and commercializing innovative medicines that advance patient care and improve their wellbeing. For more information visit: http://www.eusapharma.com.


Dinutuximab beta, originally developed by the Vienna-based biotech company Apeiron Biologics, was previously available in Europe under a managed access program, and following the positive CHMP opinion issued in March 2017 was granted expedited EU approval. Dinutuximab beta forms a core element of the treatment guidelines for high-risk neuroblastoma. The marketing authorization is based on data developed from multiple clinical trials conducted across Europe that included over 1,000 patients receiving Dinutuximab beta. Lee Morley, EUSA Pharma's Chief Executive Officer, said, "We are delighted with this expedited EU approval for Dinutuximab beta as it provides an important new therapeutic option for children with high-risk neuroblastoma who currently have limited treatment choices. Neuroblastoma is a devastating disease that is responsible for up to 10% of childhood tumors, and EUSA is working hard to bring this life-saving therapy to children around the world. As part of this mission we plan to launch Dinutuximab beta immediately across the EU with our own team. In parallel we will file Dinutuximab beta with the FDA for approval in the United States as well as work with selected partners in other territories to secure access to Dinutuximab beta for patients worldwide." Neuroblastoma is an orphan oncology condition with significant unmet medical need.  It accounts for up to 10% of childhood tumors and affects approximately 1,200 children in Europe each year.  Dinutuximab beta has been used extensively across Europe under a managed access scheme and is included in a number of treatment protocols for high-risk neuroblastoma. Dinutuximab beta is an anti-GD2 monoclonal antibody that significantly improves event-free and overall survival in children with high- risk neuroblastoma, with a favorable safety profile compared with other immunotherapies. Dinutuximab beta forms an important part of treatment regimens for high-risk neuroblastoma and its novel features offer the potential for further development to expand its current role. Dinutuximab beta has orphan drug designation in the US, and EUSA plans to file the product for approval in the United States in 2017. Dinutuximab beta is approved in Europe for use in children aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma, with or without residual disease.  In patients with previous relapsed / refractory disease and in patients who have not achieved a complete response after first line therapy, Dinutuximab beta should be combined with interleukin-2 (IL-2).  Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company with commercial operations in the US and Europe, and a wider distribution network in approximately 40 further countries.  Currently, EUSA has a broad portfolio of approved and named-patient specialty hospital products, which the company has ambitious plans to expand through acquisition and in-licensing.  EUSA is led by an experienced management team with a strong record of building successful specialty pharmaceutical companies, and is supported by significant funding raised from leading life science investor Essex Woodlands. In addition to Dinutuximab beta, EUSA Pharma's products include: Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy; Collatamp®, a gentamicin-collagen implant licensed either in hemostasis or for the prevention and treatment of surgical site infection; Custodiol® solution for use in the preservation of organs for transplantation; Fomepizole® for the treatment of ethylene glycol poisoning; and Xenazine® for the treatment of abnormal movements associated with Huntington's chorea and hemiballismus.  EUSA also has exclusive European, Latin American, North and South African and selected Middle East and Asian rights to tivozanib, which is currently under review by EMA for the treatment of advanced renal cell carcinoma.  For more information visit http://www.eusapharma.com.


BEIJING--(BUSINESS WIRE)--CANbridge Life Sciences and Amoy Diagnostics announced that they have entered into a strategic partnership to develop a companion diagnostic assay for CANbridge’s lead candidate, CAN008, a fully human Fc fusion protein. Previous clinical work, in a Phase II trial conducted in Europe, demonstrated a significant overall survival benefit for recurrent glioblastoma multiforme (GBM) patients with high expression of the CD95 ligand, or low methylation of CD95L promotor, CpG2. CAN008 is currently in a Phase I/II clinical study in GBM patients in Taiwan. CANbridge plans to initiate a CAN008 Phase II trial in GBM in China in 2018. The patients will be screened for the CAN008 biomarkers to determine trial enrollment eligibility. “We are pleased to partner with AmoyDx, a leader in providing highly-reliable and effective diagnostic solutions to clinical practices in China,” said James Xue, CANbridge Chairman and CEO. “AmoyDx’s diagnostic CD95 IHC and CpG2 qPCR kits will provide CANbridge with personalized medicine tools in the Phase II trial to deliver optimized treatment to GBM patients as early as possible.” “We are excited that our diagnostic technology will play a key role in the CAN008 clinical development,” said Dr. Li-Mou Zheng, Chairman and CEO of AmoyDx. “We believe that the joint effort by CANbridge and AmoyDx could help to realize the therapeutic potential of CAN008 in critically-ill GBM patients in China sooner. AmoyDx has multiple existing strategic partnerships with multi-national corporations providing diagnostic products and services in China and other countries. The CANbridge – AmoyDx collaboration is the first in which both parties are innovative Chinese companies with leadership positions in their respective fields.” CAN-008 is a fully human fusion protein which consists of the extracellular domain of CD95, fused to the Fc region of human IgG that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s previous developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN-008 for GBM and other indications, in China, Hong Kong and Macau, which was recently expanded to include Taiwan. Amoy Diagnostics Co., Ltd. (AmoyDx) focuses on molecular diagnostics for oncology precision medicine. With completely independent intellectual property rights to ADx-ARMS and Super-ARMS technologies, AmoyDx has a market-leading portfolio of molecular diagnostic kits, including, but not limited to, EGFR, RAS, ALK, BRAF, PIK3CA and ROS1 testing kits, approved by the CFDA and CE certified as well. In European EMQN and Chinese PQCC programs, AmoyDx has been the No.1 test kit supplier for multiple years with the highest accuracy rate. Currently, AmoyDx serves an extensive domestic and international oncology network, reaching over 300 hospitals in China and 50 countries all over the world. Every year, hundreds of thousands of cancer patients benefit from AmoyDx products. AmoyDx is strategic partner of AstraZeneca, Boehringer-Ingelheim, Pfizer, Merck and Illumina, providing diagnostic products and services for medicine development and clinical studies in gene tissue and blood testing. For more information, please visit the website: www.amoydx.com. CANbridge Life Sciences, Ltd. is a clinical-stage bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). CANbridge develops partnerships with Western bio-pharmaceutical companies, with clinical-stage pharmaceutical, medical device or diagnostic products, that are either unavailable in China/North Asia or address medical needs that are underserved in the region. CANbridge also licenses, or obtains exclusive rights to develop drug and device products that are approved in their home markets for commercialization in China and North Asia. CANbridge has an agreement with EUSA Pharma to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, for the treatment of glioblastoma multiforme in China, Macao, Hong Kong and Taiwan, where it will be developed as CAN008. CANbridge also holds a worldwide license (ex-North America) with AVEO Oncology to develop, manufacture and commercialize clinical-stage ErbB3 (HER3) inhibitory antibody candidate AV-203, renamed by CANbridge as CAN017. Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions. CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Life Sciences, please go to www.canbridgepharma.com.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVEO Oncology (NASDAQ:AVEO) today announced its European licensee for tivozanib, EUSA Pharma, has completed an oral explanation to the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), as part of the Marketing Authorization Application (MAA) review process for tivozanib as a treatment for patients with first-line renal cell carcinoma (RCC). It is expected that with the oral explanation complete, the CHMP will proceed to an opinion which they will submit to the European Commission (EC), which has the authority to approve medicines for use in the 28 countries in the European Union. The opinion is expected to be announced at a future CHMP meeting. “We are pleased that the file continues to progress through the CHMP review process with EUSA having completed an oral explanation for tivozanib,” said Michael Bailey, president and chief executive officer of AVEO. “We believe tivozanib’s unique tolerability profile, together with the longest progression free survival from a Phase 3 first line RCC study, demonstrates its potential to enhance treatment options for RCC patients.” RCC is the most common form of kidney cancer,i which accounts for an estimated 49,000 deaths in Europe each year.ii It is expected to be one of the fastest increasing cancers over the next ten years.iii Tyrosine Kinase Inhibitor (TKI) vascular endothelial growth factor (VEGF) inhibitors are the gold standard treatment for advanced RCC in Europe, however, patients on current treatments can often experience significant side effects.iv,v Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers. AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The Company is focused on seeking to develop and commercialize its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). For more information, please visit the company’s website at www.aveooncology.com. This press release contains forward-looking statements of AVEO that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “could,” “should,” “would,” “seek,” “look forward,” “advance,” “goal,” “strategy,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the Company’s expectation that the CHMP will proceed to an opinion in connection with its review process for tivozanib as a treatment for RCC, that they will announce such opinion at a future CHMP meeting and will submit such opinion to the EC; AVEO’s beliefs about the potential therapeutic benefits of tivozanib as a treatment, including for RCC; AVEO’s strategy, prospects, plans and objectives, including those that relate to advancing therapeutics, including tivozanib, and for leveraging collaborations. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: whether the tivozanib file will continue to progress through the CHMP on the time frame and manner currently expected; AVEO’s ability to enter into and maintain its third party collaboration agreements; the ability of AVEO and its licensees and other partners to achieve development and commercialization objectives under these arrangements, including, in the case of EUSA’s, its plans to advance the development and commercialization of tivozanib in the European Union; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates, including without limitation risks relating to the ability of EUSA to successfully obtain approval of its MMA for tivozanib in the European Union. AVEO faces other risks relating to its business as well, including its ability to successfully enroll and complete clinical trials, including the TIVO-3 and TiNivo studies; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s ongoing shareholder litigation; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s Annual Report on Form 10-K for the year ended December 31, 2016, its quarterly reports on Form 10-Q and in other filings that AVEO may make with the SEC in the future. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release.


News Article | May 15, 2017
Site: www.prlog.org

-- On May 8, 2017, The European Commission has granted marketing authorization for "Dinutuximab beta Apeiron", an antibody-based immunotherapy of the rare pediatric cancer neuroblastoma. Thanks to the Vienna-based Biotech company Apeiron Biologics AG ("Apeiron") patients in Europe are now offered an additional treatment option with a promising therapy – a result of a collaborative effort of management and employees, academic institutions, Austrian private investors, business angels as well as public and private research initiatives.The drug "Dinutuximab beta Apeiron" improves the survival and chances for cure in the severe pediatric cancer neuroblastoma. The biological agent, an antibody, causes clinically relevant effects in both early and advanced stages of this aggressive disease. Based on the European Commission's marketing authorization Apeiron and its marketing partner EUSA Pharma will now be able to provide an immunotherapy for neuroblastoma in Europe and subsequently worldwide.Chief Executive Officer Hans Loibner, who set up and managed the company since 2005 and is considered the "father" of this success notes: "After years of hard work we have achieved an extraordinary medical and commercial success with this marketing approval, which is a rare event with only very few comparable biotech companies in Europe having achieved such a milestone over the past 10 years. 'We' refers to a remarkably small team of fewer than 20 employees who, together with excellent external partners, have shown what is possible with the right spirit, entrepreneurship and experience. I would like to mention some: Oliver Mutschlechner has led the team for all regulatory activities at Apeiron. Without Prof. Ruth Ladenstein from the St. Anna Children's Hospital in Vienna, the entire project would not exist. Prof. Holger Lode from the University Hospital Greifswald in Germany has provided key clinical contributions. Ulrich Granzer and his team in Munich have fundamentally supported us with their expertise in the regulatory process. Thanks to all."Apeiron was founded in 2003 by Josef Penninger, an internationally renowned Austrian researcher, scientific director of the Institute for Molecular Biotechnology Austria (IMBA) and member of the Supervisory Board of Apeiron. He added: "The most beautiful thing first: We save lives of children with this product! On top, it is now apparent that the Austrian biotech research scene is competitive in the global market place. The future tax revenue originating from this success should justify public investment into this future technology."The chairman of the Supervisory Board, Manfred Reichl, who acted as lead investor for the first time in 2007, emphasizes, "Apeiron is probably the only European biotech company having achieved such an outstanding success based exclusively private funding. Finding the required double-digit million Euro capital from private investors in Austria requires a high credibility of all persons involved." Reichl adds, "The worldwide annual sales of this product, which Apeiron will participate in significantly, are expected to reach triple digit million Euro amounts, demonstrating that the local entrepreneurial start-up culture can also be scientifically and commercially successful on an international level."The development of the antibody in Europe was initiated by Prof. Ruth Ladenstein at the St. Anna Children's Hospital and Children's Cancer Research Institute in Vienna. For more than 15 years, relevant academic clinical studies were conducted by her and by Prof. Holger Lode (University of Greifswald). She comments, "We recognised the potential of this antibody for neuroblastoma therapy at an early stage and have been working on its development together with the pan-European academic consortium SIOPEN and associated hospitals for many years. In Apeiron we have found a congenial industry partner."Neuroblastoma is an orphan oncology condition with significant unmet medical need. It accounts for up to 10% of childhood tumours and affects approximately 1,200 children in the EU5 and US each year. Dinutuximab beta was already widely used across Europe and abroad under a managed access program and was included in a number of treatment protocols for high risk neuroblastoma.Dinutuximab beta Apeiron (ch14.18/CHO;APN311) is a mouse-human chimeric anti-GD2 monoclonal antibody produced in a state-of-the art process in Chinese Hamster Ovary (CHO) cells that significantly improves event-free and overall survival in children with high risk neuroblastoma, with a favourable safety profile compared to other antibody-based neuroblastoma immunotherapies. The antibody forms an important part of treatment regimens for high risk neuroblastoma. Furthermore, its features offer the potential for further development in other malignancies to expand its current role. It has orphan drug designation for neuroblastoma treatment in the US and EU, and EUSA plans to file the product for approval in the United States in 2017.Apeiron is a private biotech company based in Vienna, Austria, engaged in innovative projects in immuno-oncology. In addition to "Dinutuximab beta Apeiron" (, ch14.18/CHO)the company is developing additional cancer immunotherapy projects:is a humanized anti-GD2 antibody-IL-2 fusion protein in clinical stage. Focus of clinical development presently is on melanoma by unique intratumoral application. A broad program is pursued to develop therapies aiming at stimulation of the immune system via novel checkpoint blockade mechanisms to fight cancer:is a preclinical project for orally available drugs, performed together with Sanofi and Evotec.is a novel individual cellular immunotherapy targeting the intracellular checkpoint cbl-b. A Phase I study in advanced cancer patients was successfully performed in the US (Wake Forest University, NC), Phase II is in planning stage.For more information visit www.apeiron- biologics.com Dr. Hans Loibner, CEOCampus-Vienna-Biocenter 51030 Vienna, AustriaT +43 / (0) 664 926 3820E hans.loibner@apeiron-biologics.comW www.apeiron-biologics.com


News Article | May 23, 2017
Site: www.businesswire.com

BEIJING--(BUSINESS WIRE)--CANbridge Life Sciences, a clinical-stage biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that it raised $25 million in a Series B round with lead investor, Lapam Capital, a Beijing-based life science venture capital firm, with a portfolio that includes Betta Pharm. Several other institution investors also participated, including: Qiming Venture Partners, Yuanming Capital, Yanyuan Capital, Biossom Investment Management and Wuxi App Tec. Haoyue Capital provided professional services. CANbridge will use the proceeds to fund the clinical trial development of its two lead compounds, CAN008 and CAN017, in China.xs CAN008, a fully-human fusion onco-immunotherapy, is currently in a Phase I/II for the treatment of glioblastoma multiforme (GBM), in Taiwan. The company plans to initiate a Phase II CAN008 GBM trial in China in 2018. CAN017, an antibody inhibitory onco-immunotherpy, will target esophageal squamous cell cancer (ESCC), the prevalent form of esophageal cancer in Asia. CANbridge has raised a total of over $40M in Series A and B financing rounds combined, and has plans for additional strategic transactions in 2017. “We are delighted with the strong response from the market in this round of financing,” said James Xue, PhD, CANbridge Chairman and CEO. “We welcome the new institutional investors, as well as appreciate the continuing support from Qiming and endorsement of our vision, strategy and programs. These funds will bolster CANbridge’s financial position and strategy to build a pipeline of leading candidates in solid-tumor oncology in China. It enables us to advance our clinical trial program in our two lead candidates, CAN008 and CAN017, in China, where we hope to address the serious needs of patients with glioblastoma multiforme and esophageal squamous cell cancer, diseases with almost no effective treatment options.” CANbridge Life Sciences, Ltd. is a clinical-stage bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). CANbridge develops partnerships with Western bio-pharmaceutical companies, with clinical-stage pharmaceutical, medical device or diagnostic products, that are either unavailable in China/North Asia or address medical needs that are underserved in the region. CANbridge also licenses, or obtains exclusive rights to develop, drug and device products that are approved in their home markets, for commercialization in China and North Asia. CANbridge has an agreement with EUSA Pharma to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, for the treatment of glioblastoma multiforme in China, Macao, Hong Kong and Taiwan, where it will be developed as CAN008. CANbridge also holds a worldwide license (ex-North America) with AVEO Oncology to develop, manufacture and commercialize clinical-stage ErbB3 (HER3) inhibitory antibody candidate, AV-203, renamed by CANbridge as CAN017. Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions. CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Life Sciences, please go to www.canbridgepharma.com.


This report studies Proteomic Cancer Biomarkers in Global market, especially in North America, Europe, China, Japan, Southeast Asia and India, focuses on top manufacturers in global market, with Production, price, revenue and market share for each manufacturer, covering  Abbott Diagnostics  Agilent Technologies  Eli Lilly & Co.  EUSA Pharma  CytoCore, Inc.  GE Healthcare  Bruker Daltonics, Inc.  Biomarker Technologies, LLC  BioCurex, Inc.  Asuragen, Inc.  DiagnoCure, Inc.  Beckman Coulter, Inc. For more information or any query mail at [email protected] Market Segment by Regions, this report splits Global into several key Regions, with production, consumption, revenue, market share and growth rate of Proteomic Cancer Biomarkers in these regions, from 2011 to 2021 (forecast), like  North America  Europe  China  Japan  Southeast Asia  India Split by product type, with production, revenue, price, market share and growth rate of each type, can be divided into  Type I  Type II  Type III Split by application, this report focuses on consumption, market share and growth rate of Proteomic Cancer Biomarkers in each application, can be divided into  Colorectal  Prostate  Lung  Breast  Ovarian Global Proteomic Cancer Biomarkers Market Research Report 2016  1 Proteomic Cancer Biomarkers Market Overview  1.1 Product Overview and Scope of Proteomic Cancer Biomarkers  1.2 Proteomic Cancer Biomarkers Segment by Type  1.2.1 Global Production Market Share of Proteomic Cancer Biomarkers by Type in 2015  1.2.2 Type I  1.2.3 Type II  1.2.4 Type III  1.3 Proteomic Cancer Biomarkers Segment by Application  1.3.1 Proteomic Cancer Biomarkers Consumption Market Share by Application in 2015  1.3.2 Colorectal  1.3.3 Prostate  1.3.4 Lung  1.3.5 Breast  1.3.6 Ovarian  1.4 Proteomic Cancer Biomarkers Market by Region  1.4.1 North America Status and Prospect (2011-2021)  1.4.2 Europe Status and Prospect (2011-2021)  1.4.3 China Status and Prospect (2011-2021)  1.4.4 Japan Status and Prospect (2011-2021)  1.4.5 Southeast Asia Status and Prospect (2011-2021)  1.4.6 India Status and Prospect (2011-2021)  1.5 Global Market Size (Value) of Proteomic Cancer Biomarkers (2011-2021) 7 Global Proteomic Cancer Biomarkers Manufacturers Profiles/Analysis  7.1 Abbott Diagnostics  7.1.1 Company Basic Information, Manufacturing Base and Its Competitors  7.1.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.1.2.1 Type I  7.1.2.2 Type II  7.1.3 Abbott Diagnostics Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.1.4 Main Business/Business Overview  7.2 Agilent Technologies  7.2.1 Company Basic Information, Manufacturing Base and Its Competitors  7.2.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.2.2.1 Type I  7.2.2.2 Type II  7.2.3 Agilent Technologies Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.2.4 Main Business/Business Overview  7.3 Eli Lilly & Co.  7.3.1 Company Basic Information, Manufacturing Base and Its Competitors  7.3.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.3.2.1 Type I  7.3.2.2 Type II  7.3.3 Eli Lilly & Co. Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.3.4 Main Business/Business Overview  7.4 EUSA Pharma  7.4.1 Company Basic Information, Manufacturing Base and Its Competitors  7.4.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.4.2.1 Type I  7.4.2.2 Type II  7.4.3 EUSA Pharma Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.4.4 Main Business/Business Overview  7.5 CytoCore, Inc.  7.5.1 Company Basic Information, Manufacturing Base and Its Competitors  7.5.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.5.2.1 Type I  7.5.2.2 Type II  7.5.3 CytoCore, Inc. Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.5.4 Main Business/Business Overview  7.6 GE Healthcare  7.6.1 Company Basic Information, Manufacturing Base and Its Competitors  7.6.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.6.2.1 Type I  7.6.2.2 Type II  7.6.3 GE Healthcare Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.6.4 Main Business/Business Overview  7.7 Bruker Daltonics, Inc.  7.7.1 Company Basic Information, Manufacturing Base and Its Competitors  7.7.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.7.2.1 Type I  7.7.2.2 Type II For more information or any query mail at [email protected] Wise Guy Reports is part of the Wise Guy Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe. Wise Guy Reports features an exhaustive list of market research reports from hundreds of publishers worldwide. We boast a database spanning virtually every market category and an even more comprehensive collection of market research reports under these categories and sub-categories.


News Article | November 7, 2016
Site: globenewswire.com

MORRISTOWN, N.J., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX), a specialty pharmaceutical company with a focus on Pain and CNS conditions, today announced the appointment of Graham G. Miao, Ph.D. and Dennis H. Langer, M.D., J.D. to its Board of Directors, effective immediately. The Board also determined that Dr. Langer is an independent director and appointed him as chairperson of the Compensation Committee and as a member of the Audit and Nominating Committees. Accordingly, Pernix regained compliance with NASDAQ Listing Rule 5605(c)(2)(A), which requires Pernix to have at least three independent directors on its Audit Committee for continued listing on The NASDAQ Global Market. “I’m pleased to welcome Dr. Miao and Dr. Langer to the Board,” said John Sedor, Chairman and Chief Executive Officer. “Dr. Miao and Dr. Langer are industry leaders. Their breadth of knowledge and experience will provide invaluable insight to Pernix as we move forward with the vision that I outlined when I first took over as Chief Executive Officer – to grow our current brands, pursue other growth opportunities and, ultimately, maximize shareholder value.” Dr. Miao has served as Pernix’s President and Chief Financial Officer since July 2016. He was Senior Advisor to the Pernix interim CEO and Board of Directors from May 2016 to July 2016. Prior to joining Pernix, Dr. Miao served as Executive Vice President, Chief Financial Officer of PDI, Inc., a NASDAQ listed healthcare commercialization and molecular diagnostic company, from October 2014 until March 2016. In this role, he helped achieve double-digit revenue growth and lead the successful sale of PDI's contract sales business to Publicis Healthcare. From September 2011 to September 2014, Dr. Miao served as Executive Vice President and Chief Financial Officer and held the additional role as Co-President and Co-Chief Executive Officer from September 2013 to September 2014 of Delcath Systems, Inc., a NASDAQ traded specialty pharmaceutical and medical device company focused on cancer treatment. From September 2009 until September 2011, Dr. Miao served as Chief of Staff for the Global CFO Organization at Dun & Bradstreet Corporation. Previously, Dr. Miao held senior management roles including EVP and CFO at Pagoda Pharmaceuticals and Vice President of Strategic Planning & Financial Analysis at Symrise Inc. He also worked at Schering-Plough Corporation, serving as division CFO for the company's $3 billion primary care pharmaceuticals franchise. Dr. Miao held management roles at Pharmacia Corporation, including division CFO for the company's $1.3 billion Global Oncology franchise where he led finance teams across marketing, sales, medical affairs, business development, and mergers & acquisitions. Earlier in his career, Dr. Miao worked as a biotechnology equity analyst at J.P. Morgan and a research scientist at Roche. Dr. Miao earned an M.B.A. in Finance and a Ph.D., M.Phil., M.A. in Biological Sciences from Columbia University, an M.S. in Molecular Biology from Arizona State University, and a B.S. in Biology from Fudan University. Dr. Langer has served as director of several biotechnology, specialty pharmaceutical, and diagnostic companies, and has been CEO and/or co-founder of several health care companies. From January 2013 to July 2014 he served as Chairman and Chief Executive Officer of AdvanDx, Inc., a healthcare solutions company. From 2005 to 2010, Dr. Langer served as a Managing Partner of Phoenix IP Ventures, a private equity/venture capital firm specializing in life sciences. Previously, he was President, North America, of Dr. Reddy’s Laboratories, Limited, a multinational pharmaceutical company. From September 1994 until January 2004, Dr. Langer held several high-level positions at GlaxoSmithKline plc, and its predecessor, SmithKline Beecham, including most recently as a Senior Vice President of Research and Development. Prior to SmithKline Beecham, Dr. Langer was President and CEO of Neose Technologies, Inc. and before that held R&D and marketing positions at pharmaceutical companies Eli Lilly and Company, Abbott Laboratories and G. D. Searle & Company. At the beginning of his career, he was a Chief Resident at Yale University School of Medicine, and held clinical fellowships at Harvard Medical School and the National Institutes of Health. Dr. Langer currently serves as a Director of Myriad Genetics, Inc., Dicerna Pharmaceuticals, Inc., and several private companies. Dr. Langer served as a Director of several pharmaceutical and biotechnology companies, including Auxilium Pharmaceuticals, Inc., Ception Therapeutics, Inc. (acquired by Cephalon, Inc.), Cytogen Corporation, (acquired by EUSA Pharma, Inc.) Delcath Systems, Inc., Myrexis, Inc. Pharmacopeia, Inc. (acquired by Ligand Pharmaceuticals, Inc.), Sirna Therapeutics, Inc. (acquired by Merck & Co., Inc.), and Transkaryotic Therapies, Inc. (acquired by Shire plc). Dr. Langer is a Clinical Professor, Department of Psychiatry, Georgetown University School of Medicine. Dr. Langer received a J.D. from Harvard Law School, a M.D. from Georgetown University School of Medicine, and a B.A. in Biology from Columbia University. About Pernix Therapeutics Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and pain management, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its integrated Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc. To learn more about Pernix Therapeutics, visit www.pernixtx.com.


ATHLONE, Ireland, Nov. 15, 2016 (GLOBE NEWSWIRE) -- Innocoll Holdings plc (Nasdaq:INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical need, today announced that it will report third quarter financial results before the open of U.S. financial markets on November 22, 2016. Innocoll management will host a webcast and conference call at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update. Interested parties may access the live webcast and call through the Investors section of the company website at www.innocoll.com or directly through the registration link. A recording will be archived on the company website for 90 days. The live call may be accessed by dialing 877-407-9039 for domestic callers and 201-689-8470 for international callers. A telephone replay of the call will be available until 11:59 p.m. ET on November 29, 2016 by dialing 877-870-5176 for domestic callers or 858-384-5517 for international callers and entering the conference code: 48285346. Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines to help patients get better. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL® for the treatment of postoperative pain and COLLAGUARD (INL-003), a barrier for the prevention of post-surgical adhesions. Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Biomet 3i and Biomet.  All of our native collagen products — from extraction/purification of type-1 collagen through final delivery form — are manufactured at our certified, integrated plant in Saal, Germany. For more information, please visit www.innocoll.com. CollaRx®, Collatamp®, COLLAGUARD®, Collieva®, CollaCare®, Collexa®, COGENZIA® LidoColl®, LiquiColl®, and XARACOLL® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVEO Oncology (NASDAQ:AVEO) today announced that its development partner, EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, has submitted its responses to the European Medicines Agency (EMA) Day 120 List of Questions. The Day 120 List of Questions were issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA)

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