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Tuesday, September 6
Drug Discovery & Development - Chemistry Update
Cell Imaging for HCS Webcast - View Archive
Emerging Advances and Applications for Cellular Imaging. Tune in to the broadcast to hear from pharma experts about their experiences in cellular imaging as it relates to High Content Screening. Register for this free webcast today dddmag.com/cellimage |
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| | September 6, 2005
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Biosensor Detects Alzheimer's Protein
Researchers at Northwestern University used a homemade biosensor to detect a toxic protein they suspect may trigger the earliest symptoms of Alzheimer's disease. Full Article
Small Biotech Taps Scripps Florida
NeoRx Corp., a cancer therapeutics development company, has entered into the first research alliance with Scripps Florida, the newly established division of The Scripps Research Institute, to discover novel, small-molecule, multi-targeted, protein kinase inhibitors as therapeutic agents, including cancer treatments. Full Article
Delivering Genes via Nonviral Vector
Using silicon-based nanoparticles, researchers at the State University of N.Y., Buffalo, targeting neurological diseases, delivered genes into the brains of living mice. This technique, they say, may offer a precise, safer alternative to the use of viral vectors for therapeutic gene delivery. Full Article
Screen Finds Molecules Against Alzheimer's Disease
A group of researchers from the Neuroscience Research Institute, University of California, Santa Barbara, performed a high-throughput screen for small molecules against Alzheimer's and found three that are candidates for development as drugs. Full Article
NMR Method Rapidly Solves Proteins
Using a method called called G-matrix Fourier Transform-Nuclear Magnetic Resonance, a team of structural genomics scientists demonstrated how they determined the structures of eight proteins in just 10 to 20 days per protein, instead of the average of six to 12 months to solve a single protein using conventional NMR methods. Full Article
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NSF Creates Three New Chemical Bonding Centers
The National Science Foundation (NSF) will fund three new Chemical Bonding Centers, based at the California Institute of Technology, Pasadena, Calif., Columbia University, New York, and the University of California at Irvine. Respectively, their missions are to seek new and more economical ways of storing solar energy, to illuminate the inner workings of molecules, and to create new kinds of nanoscale molecular machines for drug delivery and other applications.
Researchers Synthesize New Class of Carbenes
Chemists at the University of California, Riverside, have synthesized a new class of highly reactive carbenes, which are molecules having a carbon atom with six electrons instead of eight. Called cyclic alkyl amino carbenes, the molecules attach to metals to form highly efficient catalysts that allow chemical transformations otherwise considered impossible. These catalysts can be used at room temperature and in smaller amounts than is necessary for other catalysts.
New Chemistry Method Uses Unprecedented Scale
Using a water droplet as a nanoscale test tube, a University of Washington, Seattle, associate chemistry professor and his team are conducting chemical analysis and experimentation at miniscule scales. This microfluidics method captures a small subcellular structure, called an organelle, within a droplet, then uses a laser microscope to study the contents and examine chemical processes, while researchers use lasers to manipulate it and conduct analysis and experimentation.
ChemAxon Launches Marvin 4.0 and 3D Visualization Tool
ChemAxon Ltd., Budapest, Hungary, released version 4.0 of its platform-independent chemical editing and visualization suite Marvin, a Java-based chemical editor and visualization toolkit. The release also includes the launch of MarvinSpace, a tool for 3D molecular structure visualization. Marvin is comprised of 5 components to create and edit structures, to view structural/nonstructural data, to analyze macromolecule/ligand interactions, to generate 2D/3D coordinates, convert chemical file types, and generate images, and structure-based calculations and predictions for properties useful in life science research.
Eidogen-Sertanty Expands its Kinase Structure-Activity Database
Eidogen-Sertanty Inc., San Diego, a computational drug discovery solutions provider, has significantly increased the size of its Kinase Knowledgebase (KKB), a structure-activity and chemistry database focused on kinase modulators. The KKB contains more than 390,000 unique kinase molecules and more than 160,000 quality-checked SAR data points mined from over 1,900 journal articles and patents. The data focuses on kinase targets of high pharmaceutical interest, such as receptor tyrosine kinases, cell division kinases, and kinases involved in disease-relevant signal transduction pathways. The Kinase Knowledgebase is released quarterly and has a growth rate of over 50,000 SAR data points and over 90,000 unique structures per year.
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Automating Compound Management Systems
While most major pharmaceutical companies have alleviated bottlenecks in their chemical compound libraries for their high-throughput screening programs by increasing automation, these systems have pushed the bottlenecks further downstream to areas such as assay design and validation. Full Article
BioDiscovery Online Conference and Expo 2 Gearing Up
Although the live event is still months away, you can get a peek at the s peakers whoíve already agreed to participate in this exciting online conference featuring talks on HTS Assay Technologies, High-Content Screening Tools, and Automation and Information Strategies. The conference will also feature a video keynote talk by Janet Woodcock, MD, Deputy Commissioner for Operations and Chief Operating Officer, U.S. Food and Drug Administration, who will speak on ìImproving the Success of Drug Development: Can We Find Better Predictive Markers?î Posters and white papers can also be submitted for inclusion in the conferenceís Resource Center. For more information, or to preregister for the event, which will premiere on October 26, please visit: www.biodiscoveryexpo.com.
Archived Webcasts Now Available
A Technical Discussion on Whole Genome Amplification, held on Wednesday, April 27, 2005, features three experts on genomic techniques who presented their perspectives on the available WGA technologies and how they are being leveraged. Panelists include Gregory James Tranah, PhD, MS, a postdoctoral fellow in the Department of Epidemiology at Harvard School of Public Health; Paul Wood, MS, associate director of the Genomics and Proteomics Core Laboratories at the University of Pittsburgh; and Rebecca Deadman, section manager, Development for GE Healthcare, and gain insight into the best practices for troubleshooting these issues. For more information and to register for the archived Webcast, go to: www.genpromag.com
Emerging Advances and Applications for Cellular Imaging-Part 2: Focus on Image Analysis, held Wednesday, May 4, 2005, helps viewers discover how to maximize their cellular imaging data and answer the questions: What are some of the latest cellular image analysis tools available to assay developers? What drives the choices they make? And, what is missing? An authoritative panel featuring Ralph Garippa, PhD, research leader, Cell-Based HTS & Robotics for Hoffmann-La Roche Inc.; David Evans, PhD, head of Drug Discovery, Translational Genomics Research Institute; and Jeffrey R. Cook, PhD, senior scientist, applications, for GE Healthcare spoke about their experiences dealing with the challenge of effective capture and analysis of cellular imaging data. For more information and to register for the archived Webcast, go to: www.dddmag.com
Approaches to Detection and Identification of Protein Biomarkers, held June 14, 2005, discusses when detecting and measuring the levels of a biomarker, what is needed is a fast, reliable, and reproducible assay and detection platform that can provide an easy way to quantify differences in expression patterns. Several platforms offer high-throughput, sensitive protein measurements such as 2D gel electrophoresis, multi-dimensional liquid chromatography, and others. An authoritative panel featuring Kevin K.W. Wang, PhD, Director of the Center for Neuroproteomics & Biomarkers Research, University of Florida; Andrew J. Dorner, PhD, Senior Director, Molecular Profiling and Biomarker Discovery, Wyeth Research; and G. Reid Asbury, PhD, Applications Manager, Protein Discovery, GE Healthcare, reviewed the advantages and drawbacks in using these various approaches to compare and contrast samples and expression patterns. For more information and to register, go to: www.dddmag.com
The Quest for an Ideal Multiplexed Protein Profiling Tool, held June 29, 2005 featured a panel of experts discussing what to consider when choosing multiplexed protein profiling technologies, including cost, throughput, standardization, ease of use, data analysis, etc. There are several platforms that have been applied toward answering these challenges, ranging from approaches like 2D gel electrophoresis, 2D-DIGE, mass spec affinity tagging, and multi-dimensional liquid chromatography for protein profiling. The panel, consisting of David W. Speicher, PhD, Professor and Chair, Systems Biology Division, Director, Proteomics Laboratory, The Wistar Institute; David Friedman, PhD, Associate Director, Proteomics Laboratory, Mass Spectrometry Research Center, Vanderbilt University; and Michael Pisano, PhD, President & Co-Founder, Proteome Research Services Inc., considered which of these offers the best capability for comparing and contrasting samples. For more information and to register, go to: www.genpromag.com
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September 2005
Workshop on Accelerator Mass Spectrometry in Low Dose Bioscience
Berkeley, Calif. - September 9
View Event Listing
SBS 11th Annual Conference and Exhibition: From Targets to Candidates
Geneva, Switzerland - September 11-15
View Event Listing
IBCís 4th Annual Molecular Diagnostics and Personalized Medicine
Scientific, Business and Regulatory Strategies for Companion Diagnostic Products and Advanced Applications
Boston, Mass. - September 12-15
View Event Listing
PABORD 2005
London, UK - September 14-15
View Event Listing
IICS 2005: 18th International Ion Chromatography Symposium
Waltham, Mass - September 20-21
View Event Listing
Ion Channel Targets
Washington, DC - September 26-27
View Event Listing
Implementing a New Paradigm in Oncology Drug Development
Washington, DC - September 26-27
View Event Listing
November 2005
ISPPP 2005: 25th International Symposium on the Separation of Proteins, Peptides, and Polynucleotides
St. Pete Beach, Fla. - November 6-9
View Event Listing
AAPS Annual Meeting and Exposition
Nashville, Tenn. - November 6-10
View Event Listing
Next Generation Protein TherapeuticsScreening for Biologics
Basel, Switzerland - November 8-10
View Event Listing |
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A Better Way To Ambush AIDS?
Panacos Pharmaceuticals' experimental drug opens the door to a new line of attack
Link to Article
businessweek.com
CDERWEEK 8/29 - 9/2/2005
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 | Date: August 29 - September 2, 2005 |
| September 2, 2005- CDER Organization Charts
 (updated) - New and Generic Drug Approvals
- Amlodipine Besylate Tabelts, Roxane Labs, Tentative Approval
- Argatroban Injection, Encysive Pharma, Labeling Revision
- Mirtazapine Orally Disintegrating Tablets, Amide Pharma, Approval
- ParaGard Copper T 380 A (intrauterine device), FEI Women's Health, Efficacy Supplement w/Clinical Data
- Potassium Chloride in Dextrose and Sodium Chloride Injection, B. Braun Med, Labeling Revision
- Potassium Chloride in Sodium Chloride Injection, B. Braun Med, Labeling Revision
- Zocor (simvastatin) Tablets, Merck & Co., Labeling Revision
September 1, 2005August 31, 2005- 2005 FDA cGMP China Training Program, December 5-7, Bejing, China. Program Information
- FDA Offers Valuable Information about Drug Use and Safety in the Aftermath of Hurricane Katrina
- Genentech and FDA notify healthcare professionals of updated cardiotoxicity information related to the use of Herceptin (trastuzumab). MedWatch Safety Info.
- Comprehensive List of Guidance Documents
- Drug Approval Reports
- New and Generic Drug Approvals
- Baclofen Tablets, Vintage Pharma, Approval
- Baclofen Tablets, Vintage Pharma, Approval
- Fexofenadine Hydrochloride Tablets, Barr Labs, Approval
- INCRELEX (mecasermin [rDNA origin] injection), Tercica, Approval
- NUBAIN (nalbuphine HCl) Injection, Endo Pharma, Supplement
- Premarin (conjugated estrogens) Vaginal Cream, Wyeth Pharma, Labeling Revision
- Premarin (conjugated estrogens) Injection, Wyeth Pharma, Labeling Revision
- Office of Generic Drugs: Question-Based Review for CMC Evaluations of ANDAs
August 30, 2005- New and Generic Drug Approvals
- Actoplus Met (pioglitazone and metformin HCl) Tablets, Takeda Global, Approval
- Cholestyramine Oral Suspension, Par Pharma, Approval 077204
- Cholestyramine Light Oral Suspension, Par Pharma, Approval
- Gastrografin (Diatrizoate Meglumine) Solution, Bracco Diagnostics, Control Supplement
- Tigan (trimethobenzamide hydrochloride) Injection, King Pharma, Formulation Revision, Package Change & Manufacturing Change or Addition
- Ramelteon Tablets (marketed as Rozerem): Patient Information Sheet [HTML] [PDF]
August 29, 2005- Custom RX Compounding Pharmacy and FDA announce a nationwide recall of Trypan Blue 0.06% Ophthalmic Solution. MedWatch Safety Info.
- Drug Shortage: Drug to be Discontinued; 1.5% Xylocaine-MPF with Dextrose 7.5% Injection (lidocaine HCl and dextrose anhydrous Injection ampules)
- Drugs@FDA Downloadable Data Files
- Mailing address changes for Therapeutic Biological Products: INDs, BLAs, and advertising and promotional labeling.
- New and Generic Drug Approvals
- Clarithromycin Tablets, Sandoz, Approval
- Clarithromycin Extended-Release Tablets, Sandoz, Approval
- Fluconazole Injection, Hikma Farmaceutica, Approval
- Follistim AQ (follitropin beta) Injection, Organon, Approval
- Granisetron HCI Injection, Baxter Healthcare, Tentative Approval
- Ondansetron Hydrochloride Tablets, Mylan Pharma, Tentative Approval
- Prednisolone Syrup, Apotex, Approval
- Prednisolone Syrup, Apotex, Approval
- Serostim (somatropin [rDNA origin]) Injection, Serono, Labeling Revision
- Ventavis (iloprost) Inhalation Solution, CoTherix, New or Modified Indication & Formulation Revision
- Visipaque (iodixanol) Injection, GE Healthcare, Package Change
- Zidovudine Tablets, Aurobindo Pharma, Tentative Approval
- Presentations from the 41st Annual Meeting of the Drug Information Association, June 26-30, 2005, Washington DC
We welcome any feedback or suggestions. webmaster@cder.fda.gov. If you prefer to subscribe to the previous text-only version, please send us a message.
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Center for Drug Evaluation and Research
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Chiron rebuffs Novartis’ takeover offer
06/09/2005 - US biotechnology company Chiron has rejected a takeover offer from Swiss drugmaker Novartis, saying the latter’s $40 a share offer does not pass muster.
Link to Article
In-PharmaTechnologist.com
How 'dirt' could educate the immune system and help treat asthma
| |  | How 'dirt' could educate the immune system and help treat asthma | | | 4 September 2005 -- Scientists believe that knowing exactly which type of dirt provides the best education for the immune system, could be key to providing new treatments for diseases such as asthma. Full Details |
Healthorbit.ca
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