--------- September 9 - 07 ---------

 

+++ PharmCast.com's Patent/Technology Available for Licensing +++

Patent Available for Licensing:
“Polynucleotides for Inhibiting Metastasis and Tumor Cell Growth”
US Patent Number 6,268,350
Patent describes successful demonstration of the administration of FasL antisense and FasL sense polynucleotides in treatment of cancer patients with a solid, non-lymphoid tumor and/or its metastasis.

http://www.pharmcast.com/PatentToSubWeb/Licensing/AvailablePatents/BioCrystal/BioCrystal080807.htm
 

Do you have a patent/technology that you want to be listed on www.PharmCast.com?

http://www.pharmcast.com/PatentToSubWeb/Licensing/Licensing.htm. listing

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

1.  Project Management for the Phase 3 & LCM (Life Cycle Management), October 3-4, 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=101&source=pharmcast
 

2.  Web Seminar: FDA’s Pharmaceutical cGMPs for the 21st Century; An Inclusive Overview, September 18, 2007.  Speaker: Calvin Koerner, Ex-FDA; President, IQ Auditing.  Organized by BenAstrum, Inc. Use promotional code PC0907 for 10% discount.

http://benastrum.com/10.html
 

3.  Patient Adherence & Persistence USA Summit, November 12-13, 2007, Philadelphia, PA.  Organized by eyeforpharma. (Use VIP code: pharmacast100 for $100 discount)

http://www.eyeforpharma.com/pcusa07
 

4.  World Drug Discovery & Development Summit 2007, December 4-5, 2007, Cologne, Germany.  Organised by World Trade Group.

http://www.wddsummit.com
 

5.  Pharma Demand Planning & Supply Chain Excellence 2007, December 4-5, 2007, London, UK.  Organized by eyeforpharma.

http://www.eyeforpharma.com/supplychain07/pharmcast
 

6.  FDA/CMS Summit, December 6-7, 2007, Washington DC.  Organized by Windhover Information, Inc.

http://www.windhover.com
 

7.  Pharmaceutical and Biotech Product Lifecycle Management, December 6-7, 2007. Location: TBA.  Organized by Arrowhead Conferences.

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

8.  12th Annual Drug & Medical Device Litigation, December 12-14, 2007, New York, NY.  Organized by American Conference Institute.

http://www.drugandmed.com/
 

9.  2008 Global Cancer Congress: Lighting the Onco-Pipeline - Pathway to Progress, January 28-29, 2008, Tampa, FL.  Organized by iiBIG.

http://www.iibig.com/P0801

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Aug2007/Home082107OG.htm


1.  Means for maintenance and/or correction of glucose concentration in blood

2.  Targeted chromosomal genomic alterations with modified single stranded oligonucleotides

3.  Cholesterol reducing chewing gum composition and method of making the same

4.  Anti-human T-cell costimulating polypeptide monoclonal antibodies

5.  Tumor therapy

6.  Stable non-aqueous single phase viscous vehicles and formulations utilizing such vehicle

7.  Immunization of dairy cattle with chimeric GapC protein against Streptococcus infection

8.  Animal model of human hematopoietic tumor

9.  Methods and compositions for treating erectile dysfunction

10.  Lipopolysaccharide .alpha.-2,3 sialyltransferase of campylobacter jejuni and its uses

11.  Chromone enteric release formulation

12.  Methods for treating or preventing angiogenesis-dependent symptoms

13.  AAV virions with decreased immunoreactivity and uses therefor

14.  Method of identifying high immune response animals

15.  Compositions and methods for treating peripheral vascular disease

16.  Use of oxidized lipoproteins for differentiation of precursor cells into mature dendritic cells

17.  M. canis-containing ringworm vaccine

18.  Preservation of bioactive materials by spray drying

19.  Self-rearranging DNA vectors

20.  Controlled release ceramic particles, compositions thereof, processes of preparation and methods of use

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

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

September 7, 2007

1.  Notice: "Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms"; Availability

2.  Notice: Foreign-Trade Zone 7--Mayag[uuml]ez, PR, Application for Subzone, Lilly del Caribe, Inc. (Pharmaceutical Manufacturing)

September 6, 2007

1.  Notice: Determination That MILTOWN (Meprobamate) Tablets and Five Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

2.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Pilot Program for Medical Products (Formally Medical Device Adverse Event Reporting Program)

September 5, 2007

1.  Notice: In the Matter of Certain Modified Vaccinia Ankara ("MVA") Viruses and Vaccines and Pharmaceutical Compositions Based Thereon; Notice of a Commission Determination Not To Review an Initial Determination Terminating the Investigation in Its Entirety Based on a Consent Order; Issuance of Consent Order

2.  Notice: Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity

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

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

September 7, 2007

1.  Workshop on Licensure of Apheresis Blood Products - 8/15/2007 (Posted 9/7/2007)

2.  BPCA/Pediatric Exclusivity Statistics:
     a.  Pediatric Exclusivity Granted (updated 9/7/2007)
     b.  Pediatric Exclusivity Statistics (updated 9/7/2007)
     c.  Written Requests Issued (updated 9/7/2007)

3.  Office of Generic Drugs: 1. Paragraph IV Patent Certifications (updated 9/7/2007)

September 6, 2007

1.  Approved Biological NDA and ANDA Applications - Update (Posted: 9/6/2007, Updated through: 8/31/2007)

2.  Cleared Biological 510(k) Device Applications - Update (Posted: 9/6/2007, Updated through: 8/31/2007)

3.  Approved Biological Premarket Approval (PMA) Device Applications - Update (Posted: 9/6/2007, Updated through: 8/31/2007)

4.  Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms (Posted 9/6/2007)

5.  Licensed Products and Establishments List - Update (Posted: 9/6/2006, Updated through: 8/31/2006)

6.  FDA approves the first generic versions of Coreg (carvedilol). FDA News (9/6/2007)

7.  FDA approves Somatuline Depot (lanreotide acetate injection) for the treatment of acromegaly. FDA News (9/6/2007)

September 5, 2007

1.  Workshop on In Vitro Analyses of Cell/Scaffold Products (Posted: 9/5/2007; Meeting Date: 12/6-7/2007)

2.  Drugs@FDA Downloadable Data Files (updated 9/5/2007)

September 4, 2007

1.  FY 2006 Annual Report - Innovative Technology Advancing Public Health (Posted: 9/4/2007)

2.  FDA Approves Second-Generation Smallpox Vaccine (Posted: 9/4/2007)

3.  Questions and Answers: ACAM2000 Smallpox (Vaccinia) Vaccine, Live (Posted: 9/4/2007)

4.  Pediatric Research Equity Act (PREA) Labeling Changes (updated 9/4/2007)

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