Is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global…From Ajinomoto Althea, Inc. – Tue, 06 Dec 2016 01:33:44 GMT – View all San Diego jobs
Bio-tech company in Sorrento Valley is now hiring entry-level Lab Technicians. Experience with Pipetting is a HUGE plus! Please attach your resume in your e-mail if you are interested.
Perform a wide variety of laboratory tasks; Ma […
The U.S. Senate cleared the way for the 21st Century Cures Act, an omnibus healthcare spending and reform bill, by voting 85-13 to end debate this evening. It passed the House with 392 votes last…
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Sangamo BioSciences Presents Hemophilia A Program Data At The 2016 American Society Of Hematology Meeting
On Track to File Investigational New Drug Application for Hemophilia A Program by End of 2016Presentation Details Development of Scalable Manufacturing Process to Support Product Development and Eventual Commercialization
RICHMOND, Calif., Dec. 5, 2016 /PRNewswire/ — Sangamo BioSciences, Inc. (Nasdaq: SGMO), the leader in therapeutic genome editing, announced the presentation of preclinical and manufacturing data that support SB-525, its gene therapy program for hemophilia A, at the 58th Annual Meeting of the American Society of Hematology (ASH) being held in San Diego, CA, from December 3-6, 2016.
“We have developed an improved gene therapy vector for treatment of hemophilia A which we believe is highly competitive, and we remain on track to file an Investigational New Drug (IND) application for our clinical program by the end of 2016,” said Sandy Macrae, M.B., Ch.B., Ph.D., Sangamo’s president and chief executive officer. “This program illustrates Sangamo’s drug development capabilities beyond our ZFP platform. Moreover, it demonstrates the ability of our R&D and technical operations teams to rapidly develop a program from research data, through positive preclinical results in relevant animal models to a clinical program fully supported by a scalable manufacturing process. We have strengthened our clinical development capabilities with recent senior management changes and are committed to consistent achievement of planned milestones for our four clinical programs. We look forward to initiating a clinical trial in 2017 to evaluate SB-525.”
The development of adenovirus associated vector (AAV) cDNA gene therapy approaches for hemophilia A has been challenging due to a number of factors, including the large size of the native human Factor 8 gene (hF8), low levels of human Factor VIII protein (hFVIII) expression from conventional promoters, and low yields of vector in large scale manufacturing processes. Through an iterative process Sangamo scientists have developed an improved AAV construct that expresses an hF8 cDNA cassette (SB-525). A single intravenous administration of SB-525 results in the expression of significant levels of hFVIII in mice and non-human primates (NHPs) and correction of the bleeding defect in a mouse model of hemophilia A. The construct also resulted in greatly improved AAV yields during vector manufacturing.
Importantly, dosing studies in NHPs which evaluated SB-525 manufactured at GMP-clinical scale demonstrated a robust and reproducible dose response curve and the most potent dose response in NHPs thus far disclosed for an hF8 cDNA gene therapy program. In these animals, mean hFVIII levels ranged from 5% of normal at the lowest dose to 230% at the highest (AAV doses in the 6 x 1011 – 6 x 1012 vgs/kg range). The therapeutic levels of hFVIII that were observed in these studies support starting clinical doses in the E11 vg/kg range.
Sangamo BioSciences, Inc. is focused on Pioneering Genetic Cures™ for monogenic and infectious diseases by deploying its AAV-based gene therapy platform, and therapeutic genome editing and gene regulation platforms based on its novel zinc finger DNA-binding protein technology. The Company’s proprietary zinc finger nuclease (ZFN)-mediated in vivo genome editing approach is focused on monogenic diseases, including hemophilia and lysosomal storage disorders MPS I and MPS II. Sangamo has initiated a Phase 1/2 clinical trial for hemophilia B, the first in vivo genome editing application cleared by the FDA. In addition, Sangamo has Phase 1/2 and Phase 2 clinical programs in HIV/AIDS (SB-728). The Company has a strategic collaboration with Bioverativ, Biogen’s planned spin-off company for rare blood disorders, for hemoglobinopathies, including sickle cell disease and beta-thalassemia, and with Shire International GmbH to develop therapeutics for Huntington’s disease. It has established strategic partnerships with companies in non-therapeutic applications of its technology, including Dow AgroSciences and Sigma-Aldrich Corporation. For more information about Sangamo, visit the Company’s website at www.sangamo.com.
This press release may contain forward-looking statements based on Sangamo’s current expectations. These forward-looking statements include, without limitation, the research and development of novel AAV-based gene therapy vectors for treatment of hemophilia A, therapeutic applications of Sangamo’s ZFP technology platform in hemoglobinopathies and other diseases, the anticipated timing of IND application filing and initiation of clinical trials for the hemophilia A program, and the potential of clinical dosage to drive the expression of therapeutic levels of Factor VIII expression. Actual results may differ materially from these forward-looking statements due to a number of factors, including uncertainties relating to the initiation and completion of stages of our clinical trials, whether the clinical trials will validate and support the tolerability and efficacy of ZFNs, technological challenges, Sangamo’s ability to develop commercially viable products and technological developments by our competitors. For a more detailed discussion of these and other risks, please see Sangamo’s SEC filings, including the risk factors described in its Annual Report on Form 10-K and its most recent Quarterly Report on Form 10-Q. Sangamo BioSciences, Inc. assumes no obligation to update the forward-looking information contained in this press release.
SOURCE Sangamo BioSciences, Inc.
Operations and Technical Services Manager
San Diego Medical Products Manufacturer is looking for a hands-on Operations and Technical Services Manager.
In this role, you will oversee and manage the daily activities of the production technicians and […
The Production Supervisor will directly manage the associates, technicians and operators on this high throughput (and high rate of change) biotechnology…From Illumina, Inc. – Mon, 05 Dec 2016 23:26:07 GMT – View all San Diego jobs
Neurocrine Biosciences Announces INGREZZA(TM) (valbenazine) Long-Term Data to be Presented at the 55th Annual Meeting of the American College of Neuropsychopharmacology
New One Year Safety and Efficacy Data of INGREZZA in Tardive Dyskinesia Patients
SAN DIEGO, Dec. 5, 2016 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders, announced today that two abstracts representing additional data from several clinical trials of the investigational drug INGREZZATM (valbenazine) are being presented at the Annual Meeting of the American College of Neuropsychopharmacology in Hollywood, Florida. The posters include an evaluation of the safety and effectiveness of long-term dosing of INGREZZA in the treatment of tardive dyskinesia.
The two posters that will be presented at 5:30pm ET on Monday December 5, 2016 are:
- Efficacy of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia: Results of a Long-Term Extension Study (KINECT 3 Extension)
- Safety and Tolerability of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia: Results of Long-Term Exposure Data from Three Studies
“We are pleased to share the positive and compelling long-term treatment data of INGREZZA in tardive dyskinesia patients with the broader scientific community,” said Chris O’Brien, M.D. Chief Medical Officer of Neurocrine Biosciences. “The results presented today are encouraging for both patients and prescribers and demonstrate that INGREZZA has the potential to bring long-term relief to patients suffering from tardive dyskinesia.”
The abstracts show that throughout the one year of treatment with INGREZZA, during the blinded, extension phase of the study, subjects continued to demonstrate sustained improvement in the reduction of their tardive dyskinesia symptoms after the six-week placebo-controlled portion of the study was completed. Additionally, the Clinical Global Impression of Tardive Dyskinesia Symptoms showed a clinically meaningful improvement in symptoms at the end of treatment. The one-year safety data indicates that INGREZZA was generally well tolerated, with no notable change in adverse event frequency over the year of dosing. Importantly, the evaluations utilizing various psychiatric scales over the period of treatment showed no worsening of underlying psychiatric health status (schizophrenia or mood disorders).
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive movements of the face, trunk, or extremities, including lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips. These symptoms are rarely reversible and there are currently no FDA approved treatments.
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in pre-synaptic neurons. INGREZZA (valbenazine or NBI-98854), developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, showing little or no affinity for VMAT1, other receptors, transporters and ion channels. INGREZZA is designed to provide low, sustained, plasma and brain concentrations of active drug to allow for once daily dosing.
Modulation of neuronal dopamine levels in diseases such as tardive dyskinesia, Tourette syndrome, Huntington’s chorea, schizophrenia, and tardive dystonia, which are characterized, in part, by a hyperdopaminergic state, may provide symptomatic benefits for patients with these diseases.
Neurocrine received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) in 2014 for INGREZZA in the treatment of tardive dyskinesia. The New Drug Application (NDA) for INGREZZA for the treatment of tardive dyskinesia is currently under Priority Review with the FDA. The proprietary name INGREZZA has been conditionally accepted by the FDA.
The Company is also investigating the safety and efficacy of INGREZZA in the treatment of Tourette syndrome. The Company has two ongoing placebo-controlled Phase II Tourette syndrome studies evaluating INGREZZA in adults and pediatrics, the T-Forward study and T-Force GREEN study, respectively. Additionally, the Company has recently launched an open-label, fixed-dose rollover study of INGREZZA in up to 180 subjects with Tourette syndrome.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. discovers and develops innovative and life-changing pharmaceuticals, in diseases with high unmet medical needs, through its novel R&D platform, focused on neurological and endocrine based diseases and disorders. The Company’s two lead late-stage clinical programs are elagolix, a gonadotropin-releasing hormone antagonist for women’s health that is partnered with AbbVie Inc., and INGREZZA, a vesicular monoamine transporter 2 inhibitor for the treatment of movement disorders. Neurocrine plans to commercialize INGREZZA in the United States upon approval of the NDA by the FDA.
Neurocrine Biosciences, Inc. news releases are available through the Company’s website via the internet at http://www.neurocrine.com.
In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine’s business and finances in general, as well as risks and uncertainties associated with INGREZZA (valbenazine) development and commercialization. Specifically, the risks and uncertainties the Company faces include risks that INGREZZA development activities may not be completed on time or at all; risks that INGREZZA development activities may be delayed for regulatory or other reasons, may fail to demonstrate that INGREZZA is safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that INGREZZA regulatory submissions may not occur or be submitted in a timely manner; risks that INGREZZA may not obtain regulatory approval or that the U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding INGREZZA; risks that INGREZZA may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with the Company’s dependence on third parties for development and manufacturing activities related to INGREZZA; risks that the Company will be unable to raise additional funding, if required, to complete development of, or commercialize, INGREZZA; risks and uncertainties relating to competitive products or technological changes that may limit demand for INGREZZA; and other risks described in the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2016. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.
Research Analyst — Informa | Pharma Intelligence, San Diego, CA Informa Pharma Intelligence is seeking a Research Analyst to join its San Diego Meddevicetracker team. Informa’s Pharma Intelligence is the trusted partner of all of the top 50 global p […
Research Analyst — Informa | Pharma Intelligence, San Diego, CA Informa Pharma Intelligence is seeking a Research Analyst to join its San Diego Biomedtracker team. Informa’s Pharma Intelligence is the trusted partner of all of the top 50 global phar […
Outstanding biotech company in Mira Mesa has an immediate opening for an entry level Bottling Technician.
Fill/cap/label finished products, data entry and completing batch records and sending samples to different QC groups.
Must be […