--------- December 2 - 07 ---------

 

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

The University of Colorado Executive MBA Program in Health Administration offers an option in Pharmaceutical Management that 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.  Stability Programs for Product Shelf Life -- From Development to Approval, January 10-11, 2008, Costa Mesa, CA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=072&source=pharmcast
 

2.  Web Seminar: Developing Stability-Indicating Methods for Pharmaceutical Products, December 13, 2007.  Speaker: Kim Huynh-Ba, President, Pharmalytik Consulting Services.  Organized by BenAstrum, Inc. (Use promotional code PC1207 for 10% discount).

http://www.benastrum.com/index.php?option=com_content&task=view&id=39&Itemid=69
 

3.  Early Commercial Input and Pharma /Biotech Product Lifecycle Management Strategies, February 28-29, 2008, San Diego, CA.  Organized by Arrowhead Conferences.

http://www.arrowheadpublishers.com/conferences/product-lifecycle-management/index.php
 

4.  2nd Annual Clinical Trials Excellence, March 3-4, 2008, Singapore.  Organized by Marcus Evans.

http://www.marcusevans.com/html/eventdetail.asp?eventID=13308&SectorID=31&divisionID=
 

5.  2nd Annual Pharmaceutical Sales & Marketing Executive Congress, March 31 – April 1, 2008, Bethesda, MD.  Organized by iiBIG.

http://www.iibig.com/P0802
 

6.  5th Annual World Health Care Congress (WHCC), April 21-23, 2008, Washington, DC.  Organized by World Congress. ($300.00 discount to PharmCast.com's visitors; use code: MPR729)

http://www.worldcongress.com/events/HR08000/index.cfm?confCode=HR08000
 

7.  US FDA Biological Approval Process December 13-14, 2007, Beijing (in Mandarin);, January 14-15, 2008, Seoul (In English);, January 17-18, 2008, Taipei (In English).  Organized by IBC Shanghai.

http://www.ibcchina.com.cn/fdaapproval
 

8.  Utilizing Biomarkers to Determine Optimal Dose, January 14-15, 2008, Philadelphia, PA.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=92
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Nov2007/Home111307OG.htm


1.  Diagnostic method for alzheimer's disease based on holo-transcobalamin II

2.  Fixed-dried platelets cross-linked to protein

3.  Method for treating allodynia by peripheral administration of a neurotoxin

4.  Stabilized liquid anti-RSV antibody formulations

5.  Analysis of HIV-1 coreceptor use in the clinical care of HIV-1-infected patients

6.  Pro108 antibody compositions and methods of use and use of Pro108 to assess cancer risk

7.  Beta-defensins

8.  Use of Lactobacillus farciminis for the prevention or treatment of digestive pathologies

9.  Coating compositions for bitterness inhibition

10.  Polynucleotide vaccine formula against canine pathologies, in particular respiratory and digestive pathologies

11.  Autoimmune conditions and NADPH oxidase defects

12.  Methods and compositions for DNA mediated gene silencing

13.  Compositions and methods for enzymatic detachment of bacterial and fungal biofilms

14.  Method to determine responsiveness of cancer to epidermal growth factor receptor targeting treatments

15.  Polyfunctional biocompatible hydrogel and method for the production thereof

16.  Matrix protein composition for treating inflammation

17.  Stable episomal vectors

18.  Parenteral formulations of a peptide for the treatment of systemic lupus erythematosus

19.  Methods of using flt3-ligand in hematopoietic cell transplantation

20.  Method for nonsurgical treatment of the intervertebral disc and kit therefor

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

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

November 30, 2007

1.  Proposed Consent Agreement: Schering-Plough Corporation; Analysis of Agreement Containing Consent Orders to Aid Public Comment

2.  Final Rule: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Rule for Over-the-Counter Antitussive Drug Products; Technical Amendment

3.  Notice: Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability

4.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

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

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

7.  Notice: Prospective Grant of Exclusive License: Development of FDA Approved HIV Resistance Diagnosis Kit

November 29, 2007

1.  Notice: Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment to Byproduct Materials License No. 21-00182-03, for Unrestricted Release of the Pharmacia & Upjohn Company's Facilities in Kalamazoo, MI

2.  Notice: Notice of Availability of Environmental Assessment and Finding of No Significant Impact for Amendment of a Materials Permit in Accordance With Byproduct Materials License No. 03-23853-01va, for Unrestricted Release of a Department of Veterans Affairs' Facility in Coatesville, PA

November 28, 2007

1.  Proposed Rule: Sunscreen Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph; Extension of Comment Period

November 27, 2007

1.  Notice: Behind the Counter Availability of Certain Drugs; Public Meeting; Comment Period Clarification

November 26, 2007

1.  Notice: Determination That ELOXATIN (Oxaliplatin for Injection), 50 and 100 Milligrams Per Vial, Sterile Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

2.  Notice: Alternative toxicological methods evaluation -- In vitro ocular toxicity test methods for identifying severe irritants and corrosives

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

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

November 30, 2007

1.  Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request (11/30/2007)

2.  Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 11/30/2007)

3.  FEDERAL REGISTER: Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule (Posted 11/30/2007)

November 29, 2007

1.  Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - Updated Agenda (Posted 11/29/2007)

2.  Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle (Posted 11/29/2007)

3.  Drug Shortage: Drug to be Discontinued; Roferon-A (Interferon alfa-2a, Recombinant) (11/29/2007)

November 28, 2007

1.  Adolescent Over-the-Counter (OTC) Drug Product Use: A Public Workshop [PDF] (11/28/2007)

2.  Drugs@FDA Downloadable Data Files (updated 11/28/2007)

3.  Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update (Posted: 11/28/2007)

November 27, 2007

1.  Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed-Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. MedWatch Information (11/27/2007)

2.  Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols (Posted 11/27/2007)

November 26, 2007

1.  FDA Manual of Policies and Procedures (MaPP) Gift Certificates/Gift Cards 4636.1R (11/26/2007)
 

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

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

1.  GlaxoSmithKline, Inc. (TYKERB (lapatinib) Tablets)

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