--------- October 29-06 ---------

 

+++ PharmCast.com's Pharmaceutical Business Intelligence Studies Highlight +++

What do you really know about the sales and marketing resources supporting your competing drugs? Pharmaceutical and biotech companies throughout the world utilize PharmaForce's primary research process to analyze competitors, conduct successful product launches, restructure/expand/create functional departments, and allocate precious marketing resources.  (5% discount to www.PharmCast.com visitors)

http://www.pharmcast.com/BuyersGuide/Software/PharmBusIntellStudies.htm

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

1.  Reporting Failure Investigations and Process Deviations,  November 15-17, 2006, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=068&source=pharmcast
 

2.  Pay for Performance: Strategies for Achieving Value and Improving Health Outcomes, November 13-14, 2006, Reston, VA.  Organized by Strategic Research Institute.

http://www.srinstitute.com/P4P
 

3.  CBI's The Original Forum on Prescription Data Restriction, November 13-14, 2006, Philadelphia, PA.  Organized by the Center for Business Intelligence.

http://www.cbinet.com/pdr
 

4.  Pharma & Biotech Collaborative Agreements, November 13-14, 2006, New York, NY.  Organized by the American Conference Institute.

http://www.americanconference.com/pharmbiocollab
 

5.  e-Communication and Online Marketing, November 13-14, 2006, Philadelphia, PA.  Organized by eyeforpharma.

http://www.eyeforpharma.com/edetailusa/pharmcast
 

6.  World Drug Manufacturing Summit, November 13-14, 2006, Berlin, Germany.  Organized by World Trade Group.

http://www.wdmsummit.com

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

http://www.pharmcast.com/PatentToSubWeb/Yr2006/Oct2006/Home101006OG.htm


1.  Nude mouse model for human neoplastic disease

2.  Gene expression vaccine

3.  Transepithelial transport of molecular species

4.  Enhancing cell-based immunotherapy

5.  Antibodies against epitopes with homology to self antigens, methods of preparation and applications thereof

6.  Crystal harvest from fermentation broth

7.  Methods for inhibiting HIV-1 infection

8.  Immunogenic formulation and process for preparation thereof

9.  13C glucose breath test for the diagnosis of diabetic indications and monitoring glycemic control

10.  Technology of intracellular delivery of DNA oligonucleotides to improve drug activity

11.  Co-processed carbohydrate system as a quick-dissolve matrix for solid dosage forms

12.  Method of treating acne

13.  Process for producing peptides by using in vitro transcription/translation system

14.  Tri(alkylcarboxylato)gallium (III) products and pharmaceutical compositions containing them

15.  Ligand for herpes simplex virus entry mediator and methods of use

16.  Preventives or remedies for endometriosis or uterine myoma

17.  Method for producing human antibodies in SCID mice which uses dendritic cells pulsed with antigen-antibody complexes and antigen-antibody complexes as immunizing agents

18.  Method and composition for preventing or reducing the symptoms of insulin resistance syndrome

19.  Universal procedure for refolding recombinant proteins

20.  Caspase 9 activation and uses therefor

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

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

October 27, 2006

1.  Notice: Intent To Grant an Exclusive License of a U.S. Government-Owned Patent

October 26, 2006

1.  Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications; Availability

2.  Notice: Approval for Expansion of Subzone 35B, Merck & Company, Inc., (Pharmaceutical Products), West Point, Pennsylvania

3.  Notice: Approval For Expansion of Subzone 61D; Merck Sharpe & Dohme Quimica De Puerto Rico, Inc. (Pharmaceutical Products); Arecibo, Puerto Rico

4.  Notice: Approval For Expansion of Subzone 61E; Merck Sharpe & Dohme Quimica De Puerto Rico, Inc. (Pharmaceutical Products); Barceloneta, Puerto Rico

5.  Notice: Approval For Expansion of Subzone 185C, Merck & Company, Inc., (Pharmaceutical Products), Elkton, Virginia

October 25, 2006

1.  Notice: Barr Pharmaceuticals, Inc. and Pliva d.d.; Analysis of Proposed Consent Order To Aid Public Comment

October 24, 2006

1.  Notice: Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability

2.  Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems; Availability

October 23, 2006

1.  Notice: Translational Research Working Group Public Comment Period

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

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

October 27, 2006

1.  Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components (Posted: 10/27/2006)

October 26, 2006

1.  On October 25, 2006, FDA approved Tyzeka (telbivudine) for the treatment of adults with chronic hepatitis B (HBV). FDA News (10/26/2006)

October 25, 2006

1.  Wyeth and FDA notify healthcare professionals of revisions to the Overdosage/Human Experience section of the prescribing information for Effexor (venlafaxine HCl), indicated for treatment of major depressive disorder. MedWatch Safety Information (10/25/2006)

2.  Heartland Repack Services and FDA notify healthcare professionals of a voluntary recall of all products containing a lot number beginning with “K” (example: K12345). MedWatch Safety Information (10/25/2006)

3.  CDER Organization Charts [HTML] [PDF] (updated 10/25/2006)

4.  Donor Screening Tests for Testing HCT/P Donors - Updates (Posted: 10/25/2006)

October 24, 2006

1.  CDER Teleconference: “An Introduction to the Improved FDA Prescription Drug Labeling” Tuesday, November 7, 2006 12:30 p.m. – 2:00 p.m. Eastern time. Teleconference Information and Registration (10/24/2006)

2.  Recall: Dupaco Blood/Fluid Warming Set, Dupaco, Inc. (Posted: 10/24/2006; Notice Date: 10/11/2006)

3.  Recovery Notice: Fluvirin (Influenza Virus Vaccine), Novartis Vaccines and Diagnostics Limited/Cardinal Health Care (Posted: 10/24/2006; Notice Date: 10/20/2006)

4.  2006 Biological Approvals - Update (Posted: 10/24/2006)

October 23, 2006

1.  FDA approves Omnaris (ciclesonide) nasal spray for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis, commonly known as hay fever. FDA News (10/23/2006)

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

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

1.  Ligand Pharmaceuticals, Inc. (ONTAK (denileukin diftitox) and Targretin (bexarotene) capsules)
 

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