--------- May 13 - 07 ---------

 

+++ BenAstrum's Pharmaceutical/Biotech Webinar Highlight+++

1.  Intact Cell Mass Spectrometry for Microbe Identification and Recombinant Protein Analysis, May 22.
2.  An Expert’s Guidance for Microbial Environmental Monitoring & Environmental Control for Aseptic Processing Facilities, May 23.
3.  FDA Audits – How to Successfully Pass a QC Analytical Laboratory Specific Audit, May 24.
4.  An Auditor’s View of FDA Requirements for QC Laboratory Compliance and A Quality System Approach to Environmental Monitoring, May 29.

http://benastrum.com/10.html


 

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

1.  Moving From Discovery Into Development, June 11-12, 2007, Costa Mesa, CA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=018&source=pharmcast
 

2.  6th Annual European Drug Discovery Partnerships, May 15-16, 2007, Berlin, Germany.  Organized by Informa Life Sciences.

http://www.informa-ls.com/drugdelivery
 

3.  FDA Boot Camp: Basic Training for Products Liability and Patent, May 15-16, 2007, San Francisco, CA.  Organized by American Conference Institute.

http://www.AmericanConference.com/fdabootcampsf
 

4.  CHI's Global R&D Congress: Strategic Planning for Discovery, Development and Clinical Operations in China, India and other Emerging Regions, May 15-16, 2007, Philadelphia, PA.  Organized by Cambridge Healthtech Institute.

http://www.healthtech.com/2007/PCG
 

5.  Advances in Microarray Technology, May 15-16, 2007, Edinburgh, UK.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/AMT2007
 

6.  Lab-on-a-Chip World Congress (Life Science Applications), May 15-16, 2007, Edinburgh, UK.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/loac2007
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/April2007/Home042407OG.htm


1.  Treatment of hepatitis C with thymosin and peptide combination therapy

2.  IL4 receptor antagonists for horse, dog and cat

3.  Method for producing temperature-sensitive morbillivirus

4.  Methods of increasing lean tissue mass using OB protein compositions

5.  Host receptor for pathogenic bacteria

6.  Peptides for the treatment of Alzheimer's disease and other beta-amyloid protein fibrillogenesis disorders

7.  Methods for enhancing the lysis of coagulated blood with apolipoprotein E2 phenotype

8.  Immunostimulatory polynucleotide/immunomodulatory molecule conjugates

9.  Method for diagnosing a person having multiple sclerosis

10.  Metallic composite coating for delivery of therapeutic agents from the surface of implantable devices

11.  Use of botuline toxin to obtain a product to be used in articular pathologies, particularly coxarthrosis, epicondylitis and rotator muscle cap pathology

12.  Common polymorphism in scn5a implicated in drug-induced cardiac arrhythmia

13.  Ovo immunization against infectious bronchitis

14.  Process for the production of rapidly disintegrating, solid pharmaceutical preparations

15.  Rapid analysis of variations in a genome

16.  Alanine- and glycine-containing therapeutic agent for hepatitis

17.  Analgesic from snake venom

18.  Chewing gum formulation and method of making the same

19.  Method and preparation for the preventing and/or treating vascular disorders and secondary disorders associated therewith

20.  Injectable and bioadhesive polymeric hydrogels as well as related methods of enzymatic preparation

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

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

May 10, 2007

1.  Notice: Guidance for Industry on Computerized Systems Used in Clinical Investigations; Availability

2.  Notice: Draft Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects--Supervisory Responsibilities of Investigators; Availability

May 9, 2007

1.  Notice: Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)

2.  Notice: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis; Availability

3.  Notice: Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds; Availability

4.  Notice: National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Request for Data on the Use of Topical Anesthetics and Systemic Analgesics for In Vivo Eye Irritation Testing

5.  Notice: National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Peer Review Panel Report on Five In Vitro Pyrogen Test Methods: Availability and Request for Public Comments

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

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

8.  Notice (C): Government-Owned Inventions; Availability for Licensing

9.  Notice: Prospective Grant of Exclusive License: Treatment of Inflammatory Bowel Disease (IBD) Using IL-13 Modulators and Inhibitors

May 8, 2007

1.  Proposed Rule: General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period

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

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

May 11, 2007

1.  2007 Biological Approvals - Update (Posted: 5/11/2007)

May 10, 2007

1.  FDA approves Neupro (rotigotine transdermal system), a skin patch designed to treat symptoms of early Parkinson's disease. FDA News (5/10/2007)

2.  Guidance for Industry: Computerized Systems Used in Clinical Investigations (PDF - 83 KB) (Posted: 5/10/2007, Publish Date: 5/10/2007)

3.  Draft Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators (PDF - 135 KB) (Posted: 5/10/2007, Publish Date: 5/10/2007)

4.  Biological Product Shortages - ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), Merck & Co, Inc. (Posted: 5/10/2007)

May 9, 2007

1.  Orange Book (Updated 5/9/2007)
     a.  Orange Book Current Cumulative Supplement (PDF)
     b.  Orange Book Information and Data Files
     c.  Orange Book Monthly Additions and Deletions: April 2007
     d.  Orange Book Query

May 8, 2007

1.  SOPP 8104: Documentation of Telephone Contacts with Regulated Industry - Update (Posted: 5/8/2007)

May 7, 2007

1.  Approved Biological NDA and ANDA Applications - Update (Posted: 5/7/2007, Updated through: 4/30/2007)

2.  Licensed Products and Establishments List - Update (Posted: 5/7/2007, Updated through: 4/30/2007)

3.  BPCA/Pediatric Exclusivity Statistics (updated 5/7/2007):
     a.  Written Requests Issued
     b.  Written Requests Statistics
 

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

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

1.  DUSA Pharmaceuticals, Inc. (Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution, 20%)

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