--------- October 15-06 ---------

 

+++ CfPIE's Pharmaceutical/Biotech Training Courses Highlight+++

1.  Introduction to Molecular Biology Techniques - Applications in the Biotechnology and Pharmaceutical Industries, November. 1-3, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=051&source=pharmcast
 

2.  FDA Inspections of Clinical Data Systems, November 2-3, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=034&source=pharmcast
 

3.  Core Skills for Team Development, November 16-17, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=062&source=pharmcast


 

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

1.  Writing Effective Standard Operating Procedures and Other Process Documents, November 7-8, 2006, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=083&source=pharmcast
 

2.  Phase IV Clinical Trials, October 23-24, 2006, East Brunswick, NJ.  Organized by Strategic Research Institute.

http://www.srinstitute.com/pct
 

3.  Clinical Data Management, October 23-24, 2006, East Brunswick, NJ.  Organized by Strategic Research Institute.

http://www.srinstitute.com/cs391
 

4.  Maximizing Pharma Patent Life Cycles, October 23-24, 2006, New York, NY.  Organized by the American Conference Institute.

http://www.americanconference.com/lifecycles
 

5.  Pharma Marketing ROI - 6th annual European Pharmaceutical Congress, October 23-24, 2006, Amsterdam, Netherlands.  Organized by eyeforpharma.

http://www.eyeforpharma.com/marketing06/
 

6.  6th Annual Strategic Clinical Outsourcing, October 23-24, 2006, New Brunswick, NJ.  Organized by Strategic Research Institute.

http://www.srinstitute.com/cs380
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2006/Sept2006/Home092606OG.htm



1.  Methods for screening and identifying host pathogen defense genes

2.  Treatment and diagnosis of prostate cancer

3.  Cationic liposome delivery of taxanes to angiogenic blood vessels

4.  Variable region of the monoclonal antibody against the HBV S-surface antigen and a gene encoding the same

5.  Identification, diagnosis, and treatment of neuropathologies, neurotoxicities, tumors, and brain and spinal cord injuries using microelectrodes with microvoltammetry

6.  Long lasting glucagon-like peptide 2 (glp-2) for the treatment of gastrointestinal diseases and disorders

7.  Uncoupling of DNA insert propagation and expression of protein for phage display

8.  Oral or intranasal vaccines using hydrophobic complexes having proteosomes and lipopolysaccharides

9.  Nutritional supplements

10.  Molecular nanowires from single walled carbon nanotubes

11.  Allergy inhibition

12.  Modified cytokine

13.  Pulmonary administration of dry powder formulations for treating infertility

14.  Anti-metasin antibodies and their methods of use

15.  Detection of ovarian cancer based upon alpha-haptoglobin levels

16.  JTT-1 protein and methods of inhibiting lymphocyte activation

17.  Topical wound dressing and method of making same

18.  Variable heavy chain and variable light chain regions of antibodies to human platelet glycoprotein Ib alpha

19.  Method of determining cytokine dosage for myelosuppressive state

20.  Tissue electroperforation for enhanced drug delivery

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

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

October 12, 2006

1.  Notice: Guidance for Industry on Investigating Out-of-Specification Test Results for Pharmaceutical Production; Availability

2.  Notice: National Advisory Committee for Acute Exposure Guideline Levels (AEGLs) for Hazardous Substances; Proposed AEGL Values; Notice of Availability

October 11, 2006

1.  Notice: Request for Nominations for Voting Members on Public Advisory Panels or Committees

October 10, 2006

1.  Notice: Workshop on Sex Differences and the Food and Drug Administration Critical Path Initiative

October 9, 2006

1.  Notice: Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Autoimmune Diseases Including Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD) and Psoriasis

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

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

October 13, 2006

1.  Bioresearch Monitoring Information System (BMIS) File (updated 10/13/2006)

2.  Drug Approval Reports, Approval Rates by Cohort Year of Receipt (Fiscal Years) (updated 10/13/2006)
    a.  CDER Priority NDAs & BLAs (PDF)
    b.  CDER Standard NDAs & BLAs (PDF)
    c.  Efficacy Supplement Approvals: 2006
    d.  Efficacy Supplement Approvals: 2005

3.  Drug Safety Oversight Board Meeting, September 14, 2006: Public Summary (updated 10/13/2006)

October 12, 2006

1.  FDA approves Avastin (bevacizumab) in combination with carboplatin and paclitaxel for the initial systemic treatment of patients with unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer. FDA News. (10/12/2006)

2.  BPCA/Pediatric Exclusivity Statistics
    a.  Breakdown of Requested Studies Report (updated 10/12/2006)
    b.  Pediatric Exclusivity Granted (updated 10/2/2006)
    c.  Pediatric Exclusivity Statistics (updated 10/12/2006)
    d.  Spectrum of Diseases/Conditions (updated 10/12/2006)

3.  Orange Book (updated 10/12/2006)
    a.  Orange Book Current Cumulative Supplement (PDF)
    b.  Orange Book Search
    c.  Orange Book Information and Download Files
    d.  Orange Book Monthly Additions and Deletions

October 11, 2006

1.  Investigating Out-of-Specification Test Results for Pharmaceutical Production [PDF] or [HTML] (Issued 10/11/2006; Posted 10/11/2006)

2.  National Drug Code Directory (updated 10/11/2006)

3.  Drugs@FDA Downloadable Data Files (updated 10/11/2006)

October 10, 2006

1.  National Foundation for Infectious Diseases: 10th Annual Conference on Vaccine Research (Posted: 10/10/2006; Workshop Date: 4/30/2007-5/2/2007)

2.  On October 6, FDA approved Risperdal (risperidone) for the symptomatic treatment of irritability in autistic children and adolescents. FDA News (10/10/2006)

3.  On October 6, FDA and Bristol-Myers Squibb notified pharmacists and physicians of revisions to the labeling for Coumadin, to include a new patient Medication Guide as well as a reorganization and highlighting of the current safety information to better inform providers and patients. MedWatch Information (10/10/2006)

4.  Multiple Myloma Endpoints Meeting, October 26, 2006, Washington, DC. Meeting Information (10/10/2006)

5.  Current Licensed Establishments and Products - Update (Posted: 10/10/2006)

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

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

1.  Herman Zaharowitz, M.D. (Clinical Investigation)
 

_____________________________________________________________

PharmCast Dot Com, the Official www.PharmCast.com's Newsletter.

Copyright GF Communications
To ***, please go to:

http://www.pharmcast.com/Newsletter/***.htm

patents * jobs * Federal Register * news * stocks * FDA Links * Buyer's Guide