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FDA Update: March 15, 2010
3/15/2010
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TRADE NEWS: Agilent Technologies Introduces BioHPLC Columns For Characterization Of Bio-Molecules
3/15/2010
Agilent Technologies Inc. (NYSE:A) today announced the availability of new ion exchange and size exclusion columns specifically designed for the analysis of bio-molecules including monoclonal antibodies, recombinant proteins, peptides, vaccine products and DNA/RNA. The columns provide robust, reproducible and high-resolution solutions for biopharmaceutical manufacturers to effectively monitor the safety, efficacy and stability of their products. "With the addition of these new bio-columns, we can now offer our customers significant improvements in charge-based and size-based
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CLC bio Expands Next Gen Sequencing Solutions With Ground-Breaking New Algorithm For Whole-Genome De Novo Assemblies
3/15/2010
Today, CLC bio released a groundbreaking whole-genome de novo assembler that will assemble genomes of any size, including human and plant genomes on a single workstation computer. Equally important, CLC bio's de novo assembler is the first assembler that enables molecular biologists to set up, adjust, and run their large genome de novo assemblies through a graphical user-interface. Director of Scientific Software Development at CLC bio, Dr. Roald Forsberg, states: "Modest hardware requirements and
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Freeze Dryers That Deliver Results To The Pharmaceutical Industry
3/15/2010
SP Scientific Inc. has announced that they will exhibit their latest FTS™ and Virtis™ freeze-dryers and lyophilization systems at INTERPHEX 2010 (New York, NY, USA).
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Portola Pharmaceuticals And Merck Announce That Phase 2 Study Showed Investigational Factor Xa Inhibitor, Betrixaban, Reduced Incidence Of Bleeding Compared To Warfarin In Patients With Atrial Fibrillation
3/15/2010
Portola Pharmaceuticals and Merck today announced the results of EXPLORE-Xa, a Phase 2 exploratory, dose finding study of betrixaban, an investigational oral direct Factor Xa inhibitor. Results showed that a once-daily dose of oral betrixaban, given to patients with non-valvular atrial fibrillation or atrial flutter and at least one risk factor for stroke, reduced the incidence of major and clinically relevant non-major (CRNM) bleeds* compared to dose-adjusted warfarin. The data were presented during a
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BioSante Announces FDA Orphan Drug Designation for GVAX Pancreatic Cancer Vaccine
3/15/2010
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced BioSante's receipt of Orphan Drug designation from the FDA's Office of Orphan Products Development for GVAX Pancreas Vaccine in the treatment of pancreatic cancer. "The Orphan Drug designation of GVAX Pancreas Vaccine for the treatment of pancreatic cancer is BioSante's first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October," said Stephen M. Simes, BioSante's president & CEO. "It
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Whole Genome Analysis Comes Nearer To Use In Routine Diagnosis
3/12/2010
For the first time, researchers have used whole genome sequencing to achieve a molecular diagnosis in a patient with a genetic disorder. The results suggest that in the near future, genome sequencing could become a routine part of medical care, both to diagnose rare disorders and help estimate the risk of common disorders.
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Trillium Expands Immunology Pipeline And Enters Stem Cell Field Through In-Licensing Of Two New Programs
3/12/2010
Trillium Therapeutics Inc. (TTI), a biopharmaceutical company developing innovative immune-based biologics, today announced that it has entered into two definitive license agreements with University Health Network (UHN) and The Hospital for Sick Children (SickKids) in Toronto, Ontario, granting Trillium exclusive worldwide rights to commercialize two immunology programs in the areas of hematopoietic stem cell transplantation and cancer.
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Sigma-Aldrich® Licenses RAFT Polymerization Technology From CSIRO®
3/12/2010
Sigma-Aldrich (Nasdaq:
SIAL) announced today that it has entered into a worldwide licensing agreement with Australia's Commonwealth Scientific and Industrial Research Organization (CSIRO) to manufacture and sell Reversible Addition-Fragmentation chain Transfer (RAFT) agents – organic molecules that can be added to polymerization reactions to precisely control molecular weights and structures of polymers.
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CBio Secures Another Clinical Trial Milestone
3/12/2010
Australian drug development company CBio Limited (ASX: CBZ) today announced the achievement of a clinical trial milestone under its option agreement with global pharmaceutical leader Novo Nordisk A/S.
