Position Responsibilities Medidata Rave study builder including forms, edit checks, derivations, lab admin, data dictionaries and unit dictionaries. Custom
From Randstad Pharma – 19 Dec 2014 20:36:17 GMT
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About the Salk Institute for Biological Studies:
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From Beckman Coulter – 19 Dec 2014 17:50:19 GMT
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Isis Pharma shares jump to another record high after financial personality touts stock.
EVANSTON, Ill., Dec. 19, 2014 /PRNewswire/ — Naurex Inc., a biopharmaceutical company leveraging its unique platform to develop novel drugs for diseases of the central nervous system, today announced that Norbert Riedel, Ph.D., president and chief executive officer, will present at the 33rd annual J.P. Morgan Healthcare Conference. Dr. Riedel’s presentation will take place at 3:00 p.m. PST on Tuesday, January 13, 2015, at the Westin St. Francis in San Francisco, Calif.
About Naurex Inc. Naurex is a clinical stage biopharmaceutical company developing transformative therapies for challenging disorders of the central nervous system. The company has built a platform for discovering drugs that enhance synaptic plasticity, or strengthen the network for neural cell communication. Molecules discovered by Naurex achieve this through a novel mechanism that modulates the NMDA receptor – rather than shutting it down – resulting in drugs that are both highly effective and well tolerated. Naurex’s lead molecule, GLYX-13, has demonstrated rapid, robust, and sustained efficacy in multiple Phase 2 clinical studies in depression, an area of high unmet need that has seen little innovation in decades. NRX-1074, a next-generation, orally bioavailable drug candidate, is in Phase 2 clinical development in depression. Naurex’s platform has yielded a rich pipeline of subtype-selective NMDA receptor modulators with the potential to treat a broad set of psychiatric and neurologic disorders.
Media Contacts: Canale CommunicationsIan Stoneian@canalecomm.com619-849-5388
Naurex Inc. Ashish Khanna Vice President, Corporate Development email@example.com
SOURCE Naurex Inc.
He or she should feel comfortable operating on multiple platforms, writing scripts to automate testing, carrying out complex analysis, and ideally have…
From BioSpace.com – 19 Dec 2014 15:11:02 GMT
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Halozyme Receives European Orphan Drug Designation For PEGylated Recombinant Human Hyaluronidase PH20 For Pancreatic Cancer
SAN DIEGO, Dec. 19, 2014 /PRNewswire/ – Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA), has designated PEGylated recombinant human hyaluronidase (PEGPH20) an orphan medicinal product for the treatment of pancreatic cancer. Halozyme is currently conducting a Phase 2 study on the treatment of metastatic pancreatic cancer with PEGPH20 in combination with gemcitabine and nab-paclitaxel (ABRAXANE®). In October 2014, the Company disclosed that the U.S. Food and Drug Administration also granted Orphan Drug designation for PEGPH20 for the treatment of pancreatic cancer.
“We are very pleased that PEGPH20 has received orphan drug status in the EU,” stated Dr. Helen Torley, President and Chief Executive Officer. “This designation is an important regulatory milestone for Halozyme and aligns with our commitment to deliver innovative therapies that transform the lives of cancer patients around the world.”
The EMA Orphan Designation is a status assigned to a medicine intended for use against a rare condition (prevalence of the condition in the European Union must not be more than 5 in 10,000) and allows a pharmaceutical company to benefit from incentives offered by the EU to develop a medicine for the treatment, prevention or diagnosis of a disease that is life-threatening or a chronically debilitating rare disease. In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to centralized marketing authorization.
About PEGPH20PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan.
About HalozymeHalozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company’s research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme’s pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Janssen and Baxter. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.
Safe Harbor StatementIn addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning future actions relating to the development of PEGPH20 and the possibility that PEGPH20 may be used to address pancreatic cancer) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including delays in completion of clinical trials and other development activities, the possibility of safety events, unexpected expenditures and costs, unexpected results or delays in regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 10, 2014.
Investor Contact:Schond GreenwayHalozyme Therapeutics858firstname.lastname@example.org
Media Contact:Susan Neath Francis212email@example.com
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SOURCE Halozyme Therapeutics, Inc.
Three Somagenics Publications Demonstrate Successful Inhibition of the Hepatitis C Virus by Therapeutic sshRNA™ and Confirm Mechanism of Action
SANTA CRUZ, Calif., Dec. 19, 2014 /PRNewswire/ — SomaGenics and collaborators have published exciting results on the efficacy of RNA interference (RNAi) therapeutics against the hepatitis C virus (HCV) based on the company’s sshRNA™ platform. Using a chimeric mouse model with humanized liver that supports infection by HCV, SomaGenics scientists and their collaborators from Roche and Tekmira Pharmaceuticals demonstrated efficient sshRNA delivery to the liver, potent and long-lasting reduction in viral load, and strong evidence for a direct anti-viral effect by the sshRNAs. The studies were published in Molecular Therapy-Nucleic acids, in Gastroenterology, and in the Journal of Virology.
Key findings of these papers include:
Lipid-nanoparticle (LNP)-formulated sshRNAs were efficiently taken up by human liver cells in chimeric mice
Significant HCV reduction (2.0 log10 viral load reduction) was achieved with a single i.v. dose
Viral load was still depressed by 1.0 log10 three weeks after dosing
Maximal anti-viral effect was observed with two doses of a cocktail of two sshRNAs targeting different sites on the HCV genome, where a total viral load reduction of 2.5 log10 was achieved
The LNP-formulated sshRNAs were well tolerated with no evidence of liver toxicity
The therapeutic effect was convincingly demonstrated to act through an RNAi mechanism
The results illustrate the value of a feature of RNAi approaches: the ability to easily target multiple sites on the viral genome simultaneously “The demonstration of a strong antiviral effect in the chimeric humanized-liver mouse model further reinforces our confidence in the therapeutic potential of our sshRNA platform,” said Dr. Brian Johnston, CEO of SomaGenics. “We are quite excited about the performance of SomaGenics’ synthetic sshRNAs formulated with Tekmira’s LNP, which demonstrated reduction of circulating HCV load by more than two orders of magnitude and suggests that biweekly or monthly dosing could be effective. The results affirm the advantages of our approach of combining multiple sshRNAs targeting otherwise ‘undruggable’ viral targets. We are extending this platform to developing treatments for hepatitis delta, a serious form viral hepatitis for there are currently no specific treatments.”
About HCVHCV is a leading cause of cirrhosis, liver cancer, and liver failure requiring liver transplant. An estimated 170 million people are infected with HCV globally, with 3-4 million new infections each year. No vaccine is currently available.
About RNAi and SomaGenics’ sshRNA technologyThe Nobel-prize-winning discovery of RNA interference (RNAi), a process by which double-stranded RNA molecules can inhibit the function of virtually any gene, has spurred interest in the development of short interfering RNAs as drugs. SomaGenics has pioneered the discovery and development of a unique class of short interfering RNAs called sshRNAs. Structurally and mechanistically distinct from the more commonly used siRNAs and expressed shRNAs, sshRNAs are short, chemically modified RNA sequences that are synthesized as single strands. They have outstanding potency and possess attractive pharmacokinetic properties without undesirable immune stimulation.
About SomaGenicsSomaGenics is a privately held biotech company with offices and laboratories located in Santa Cruz, CA. It specializes in RNA technologies, including innovative therapeutics and diagnostics that use RNA molecules as therapeutic targets and biomarkers. Besides sshRNA, its technology platforms include miR-ID™, a novel, circularization-based RT-qPCR method for quantifying microRNAs; miR-Direct™, for detection of circulating microRNAs directly from plasma; miR-ACS™, for construction of improved next-generation sequencing libraries; and mR-FQ™, for quantifying fragmented mRNAs from preserved histology specimens.
A. Dallas, H. Ilves et al., Mol. Therapy–Nucleic Acids (2013): 17;2:e123
H. Ma, A. Dallas et al., Gastroenterology (2014) 146: 63-66
A. Dallas, H. Ilves et al., J. Virology (2014) 88(9):4647-56Aspects of the findings have also been presented by Dr. Johnston at the following scientific meetings:
American Association of Pharmaceutical Scientists (AAPS) Annual Meeting, Workshop on Emerging Trends in Nucleic Acid and Cell-Based Therapeutics, San Diego; invited lecture
3rd International Conference on Gastroenterology & Urology, San Francisco, July 28-30, 2014; invited talk
Nucleic Acid Research & Discovery conference, GTC, San Diego; invited lecture
American Society for Gene and Cell Therapy Annual Meeting (ASGCT), Washington DC; poster presentation
International Symposium on Viral Hepatitis, Varadero, Cuba; invited talk
Media Contact:Brian Johnston 831 426 7700Email
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From CareerBuilder – 19 Dec 2014 13:16:01 GMT
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