--------- September 24-06 ---------

 

+++ PharmCast.com's Executive MBA Program Highlight+++

The University of Colorado Executive MBA Program in Pharmaceutical Management provides pharmaceutical industry professionals with a Master of Business Administration degree with an emphasis in health administration and pharmaceutical management in 25 months.  Professionals in the pharmaceutical industry are being faced with management issues that are complex and involve other key players in the health care industry.  Students will learn about global issues in a classroom environment that includes a wide variety of healthcare professionals.

http://www.pharmcast.com/BuyersGuide/UColorado/UColoradoMBAInfo.htm

+++ PharmCast.com's Conference Highlight +++
 

1.  Introduction to Effective Medical Writing, October 16-17, 2006, Malvern, PA. Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=047&source=pharmcast
 

2.  Metabolic Syndrome Conference, September 25-27, 2006, Cambridge, MA. Organized by Marcus Evans.

http://www.marcusevans.com/events/CFEventinfo.asp?EventID=10903
 

3.  IT Infrastructure Qualification Summit A Proactive Approach to Compliance and Infrastructure, September 25-28, 2006, Atlanta, GA.  Organized by IQPC.

http://www.iqpc.com/NA-10517-001
 

4.  ELNS & Laboratory Informatics 2006, September 25-28, 2006, London, UK. Organized by IQPC.

http://www.iqpc.co.uk/GB-2554/PCT
 

5.  European Biomarkers Summit, September 26-27, 2006, Prague, Czech Republic. Organized by Select Biosciences Ltd.

http://www.BiomarkerSummit.com

+++ PharmCast.com's Last Week Pharmaceutical Patents +++
 

http://www.pharmcast.com/PatentToSubWeb/Yr2006/Sept2006/Home090506OG.htm


1.  Chewing gum composition containing an active ingredient

2.  Bovine growth hormone recombinantly produced in E. coli

3.  Liposome compositions and methods for the treatment of atherosclerosis

4.  Antigen presenting mesenchymal stem cells

5.  Compositions and methods involving an essential Staphylococcus aureus gene and its encoded protein

6.  Method of treating chronic pelvic pain syndrome by administration of chorionic gonadotropin

7.  Targeted retrograde gene delivery to motor neurons

8.  Nanoparticulate megestrol formulations

9.  Remedies for hepatitis C

10.  Method for the identification of gene transcripts with improved efficiency in the treatment of errors

11.  Mycobacterial proteins, microorganisms producing them and their use for vaccines and the detection of tuberculosis

12.  Antibodies of the P2Y10 receptor useful in altering T lymphocyte function

13.  Granules obtained by drying a multiple emulsion

14.  Treatments for neurotoxicity in Alzheimer's Disease

15.  Control of ph transitions during chromatography

16.  Hematopoietic cell composition for use in transplantation

17.  Immune response enhancement methods

18.  Polymeric drug formulations

19.  Methods for treating cancers and pathogen infections using antigen-presenting cells loaded with RNA

20.  Production of nanocapsules and microcapsules by layer-wise polyelectrolyte self-assembly

+++ PharmCast.com's Last Week Federal Register +++
 

http://www.pharmcast.com/FederalRegistrar/FRHome.htm
 

September 22, 2006

1.  Notice: Prospective Grant of an Option to a Co-Exclusive License: Development of Antibody-Based Therapeutics That Specifically Bind the Platelet-Derived Growth Factor Receptor Alpha (CD140A/PDGFR2/ PDGFRA)

2.  Notice (A): Government-Owned Inventions; Availability for Licensing

3.  Notice (B): Government-Owned Inventions; Availability for Licensing

4.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs

5.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations

6.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices-Foreign Letters of Approval

7.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements

September 21, 2006

1.  Notice: Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment to Byproduct Materials License No. 29-30285-01, for Termination of the License and Unrestricted Release of the SK Bio-Pharmaceutical R&D Center's Facility in Fairfield, NJ

September 20, 2006

1.  Notice: Draft Guidance for Industry on Public Availability of Labeling Changes in "Changes Being Effected" Supplements; Availability

September 19, 2006

1.  Notice: Strategy To Support Health Information Technology Among HRSA's Safety Net Providers

+++ PharmCast.com's Last Week Recent FDA Links +++

 http://www.pharmcast.com/FDALinks/FDALinksLatest.htm
 

September 22, 2006

1.  Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels (PDF, Posted: 9/22/2006)
    a.  United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 (PDF, 9/22/2006)

September 21, 2006

1.  CDER Data Standards Manual: Potency Drug Nomenclature Monograph (updated 9/21/2006)

2.  Drug to be Discontinued: Desyrel (trazodone) (9/21/2006)

September 20, 2006

1.  FDA updates the labeling for Ortho Evra (norelgestromin/ethinyl estradiol) with new safety information. Ortho Evra is a contraceptive skin patch used to prevent pregnancy. Ortho Evra Information (9/20/2006)

2.  Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update (Posted: 9/20/2006)

September 19, 2006

1.  Drug to be Discontinued: Videx (9/19/2006)

September 18, 2006

1.  FDA approves Noxafil (posaconazole) to prevent invasive fungal infections.  FDA News (9/18/2006)

+++ PharmCast.com's FDA Warning Letters +++
 

http://www.pharmcast.com/WarningLetters/LatestWL.htm
 

1.  Reliant Pharmaceuticals, Inc. (Rythmol© SR (propafenone HCl) extended release Capsules)
 

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