--------- March 18 - 07 ---------

 

+++ PharmCast.com's Pharmaceutical Software Highlight+++

Pharmaceutical Software:- The following quality software are designed specifically for pharmaceutical operations by Novatek International, NOVA-LIMS which consists of the following Modules (a) Stability Program; (b) Finished Product Analyzer; (c) Raw Material Analyzer; (d) Preventive Maintenance and Calibration; (e) Automated Packaging Component Analyzer; (f) Environmental Monitoring; (g) Document Management System, Audit and Training Program; (h) Inventory Management System.   As a visitor of www.PharmCast.com, you are entitled to a 5% discount when purchasing these software.

http://www.pharmcast.com/BuyersGuide/Novatek/NovatekProductVer2.htm

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

1.  Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products, April 10-11, 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=005&source=pharmcast
 

2.  RNAi World Congress, April 24-25, 2007, Philadelphia, PA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/RNAiWorldCongress2007
 

3.  Molecular Diagnostics World Congress, April 26-27, 2007, Philadelphia, PA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/MolDiagnostics2007
 

4.  Cancer Proteomics World Congress, April 26-27, 2007, Philadelphia, PA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/CancerProteomics2007
 

5.  Bio-IT World Conference & Expo,  April 30 - May 2, 2007, Boston, MA.  Organized by Cambridge Healthtech Institute.

http://www.bio-itworldexpo.com/
 

6.  MedEd Congress 2007, May 2-4, 2007, Philadelphia, PA.  Organized by the Institute for International Research.

http://www.iirusa.com/meded

 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Feb2007/Home022707OG.htm


1.  Method for selective expression of therapeutic genes by hyperthermia

2.  Quantitative measurement method and quantitative measurement chip for target substance

3.  Vaccine against ISA virus

4.  Particulate compositions for pulmonary delivery

5.  Use of leptin for treating human lipoatrophy and method of determining predisposition to said treatment

6.  Anti-MUC-1 single chain antibodies for tumor targeting

7.  Compositions and methods for enhancing disease resistance in fish

8.  Pharmaceutical compositions for nasal delivery of oestradiol and norethisterone

9.  Cell culture system for synthesis of infectious hepatitis C virus

10.  Anti-inflammatory peptides derived from C-reactive protein

11.  Treatment of HPV caused diseases

12.  Polypeptide variants with altered effector function

13.  Rapidly dissolving dosage form and process for making same

14.  Use of RPL41 to treat infections and inhibit cancer

15.  Feline immunoglobulin E proteins and compositions thereof

16.  Cytotoxin-based biological containment

17.  Method for identifying pre-neoplastic and/or neoplastic states in mammals

18.  Polymer blends that swell in an acidic environment and deswell in a basic environment

19.  Variant B7 co-stimulatory molecules

20.  Targeting drug/gene carriers to irradiated tissue

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

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

March 16, 2007

1.  Notice: Nominations of Topics for Evidence-based Practice Centers

March 15, 2007

1.  Notice: Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications

March 14, 2007

1.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs

March 13, 2007

1.  Notice: Guidance for Industry and Food and Drug Administration Staff; Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Availability

2.  Notice: Electronic Case Report Form Submission; Notice of Pilot Project

March 12, 2007

1.  Notice: Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing; Public Workshop

2.  Final Rule: Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation

3.  Notice: Issuance of Environmental Assessment and Finding of No Significant Impact to Byproduct Materials License 53-27775-01 for Covance Clinical Research Unit, Inc., Honolulu, HI

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

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

March 16, 2007

1.  FDA issues an FDA Alert and Healthcare Professional Sheet on new emerging safety concerns about Zyvox (linezolid) from a recent clinical study. Zyvox Information (3/16/2007)

March 15, 2007

1.  Orange Book Current Cumulative Supplement (PDF, Updated 3/15/2007)

2.  Orange Book Information and Data Files (Updated 3/15/2007)

3.  Orange Book Monthly Additions and Deletions: February 2007 (Updated 3/15/2007)

4.  Orange Book Query (Updated 3/15/2007)

5.  Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products (Posted: 3/15/2007)

6.  Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications (Posted 3/15/2007)

March 14, 2007

1.  Cyber Letters (updated 3/14/2007)

2.  FDA Requests Label Change for All Sleep Disorder Drug Products (3/14/2007)

3.  Drugs@FDA Downloadable Data Files (updated 3/14/2007)

4.  National Drug Code Directory Download (updated 3/14/2007)

5.  National Drug Code Search (updated 3/14/2007)

March 13, 2007

1.  FDA approves Tykerb (lapatinib) for advanced breast cancer patients. FDA News (3/13/2007)

2.  FEDERAL REGISTER: Electronic Case Report Form Submission; Notice of Pilot Project (Posted: 3/13/2007)

3.  Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM) (ABBOTT PRISM HBsAg); Hepatitis B Virus Core Antigen (E. coli, Recombinant) (ABBOTT PRISM HBcore) - 2/23/2007 - Abbott Laboratories (Posted: 3/13/2007)

4.  Guidance for Industry: Indexing Structured Product Labeling [PDF] or [HTML] (3/13/2007)

5.  FEDERAL REGISTER: Electronic Case Report Form Submission; Notice of Pilot Project (Posted: 3/13/2007)

March 12, 2007

1.  SOPP 8401: Administrative Processing of Biologics License Applications (BLA) (Updated/Posted: 3/12/2007)

2. Office of Generic Drugs: February First-Time Generic Drug Approvals (3/13/2007)

3. Genomics presentations (3/12/2007)
    1.  Update on the Critical Path and Personalized Medicine Initiative Implementation [PDF]
    2.  Clarifying the Current Regulatory Position on the Validation and Standardization of Biomarkers for Approval and Ongoing Patient Care [PDF]

4. FEDERAL REGISTER: Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Final Rule (Posted: 3/12/2007, Publish Date: 3/12/2007)

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

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

1.  Niagara Pharmaceuticals Inc. (Site Inspection)

_____________________________________________________________

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