--------- June 17 - 07 ---------

 

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

PharmaForce International offers a full suite of competitive analysis and market insight services that have proven to increase market share for dozens of drugs.  We specialize in providing clients with 360 degree feedback on the marketplace for your drug, including physician audience profiling, benchmarking of sales and marketing programs of key competitors, KOL assessments and pipeline analysis.  Click link below to learn more about PharmaForce's syndicated studies on the pharmaceutical industry and proprietary research capabilities (5% Discount to www.PharmCast.com Visitors)

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

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

1.  Writing Effective Standard Operating Procedures and Other Process Documents, July 12-13, 2007, Costa Mesa, CA.  Organized by The Center for Professional Innovation & Education.

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

2.  Webinar: CAPA Management to Help Comply with Regulatory Requirements June 19, 2007.  Speaker: Bernice Russell-Bond, President, BRUSSELL Consulting, Inc.  Organized by BenAstrum, Inc.

http://benastrum.com/10.html
 

3.  China Medical Diagnostics 2007, August 16-17, 2007, Beijing, China.  Organized by Marcus Evans.

http://www.marcusevans.com/events/CFEventinfo.asp?EventID=12592
 

4.  Managing R & D Outsourcing and Partnering, August 20-21, 2007, Singapore.  Organized by Marcus Evans.

http://www.marcusevans.com/events/CFEventinfo.asp?EventID=12365
 

5.  European Biomarkers Summit, September 4-5, 2007, Amsterdam, Netherlands.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/EBS2007/index.aspx
 

6.  Proteomics Europe, September 4-5, 2007, Amsterdam, Netherlands.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/proteomicseurope2007/index.aspx
 

7.  Screening Targets, September 10-11, 2007, Boston, MA.  Organized by Select Biosciences Ltd.

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

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/May2007/Home052907OG.htm


1.  Modified reoviral therapy

2.  Abuse resistant lysine amphetamine compounds

3.  Peptides for chlamydophila pneumoniae vaccine and diagnosis

4.  Method for the integration of foreign DNA into eukaryotic genomes

5.  Methods for treating restenosis with a botulinum neurotoxin

6.  Secreted and transmembrane polypeptides and nucleic acids encoding the same

7.  Malignant endothelial cell line and uses thereof in models for angiogenesis

8.  Taste masked pharmaceutical particles

9.  DNA-based vaccine against the encephalitis alphaviruses

10.  Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets

11.  Detection of proteins whose absence is associated with a neoplasm

12.  Stabilized sunscreen composition having a particulate inorganic sunscreen

13.  Broadly cross-reactive neutralizing antibodies against human immunodeficiency virus selected by Env-CD4-co-receptor complexes

14.  Antithrombosis enzyme from the snake venom of agkistrodon acutus

15.  PR0994 antibodies

16.  Herpes virus strains for gene therapy

17.  Organ arrest, protection and preservation

18.  Potentiation of anti-CD38-Immunotoxin cytotoxicity

19.  Stretchable patch

20.  Methods of treatment of fistulas in Crohn's disease with anti-TNF antibodies

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

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

June 15, 2007

1.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Label Comprehension Study

2.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Cover Sheet, FDA Form 3546

June 14, 2007

1.  Notice: Otsuka Pharmaceutical Co., Ltd.; Withdrawal of Approval of a New Drug Application

2.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions

June 13, 2007

1.  Notice: Plant Biotechnology, Inc.; Availability of an Environmental Assessment for a Field Release of Nicotiana Hybrids Genetically Engineered To Produce Antibodies

2.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products (Formally Medical Device Adverse Event Reporting Program)

June 12, 2007

1.  Notice: Health Outcomes Not Associated With Exposure to Certain Herbicide Agents

June 11, 2007

1.  Notice: Use of Ozone-Depleting Substances; Removal of Essential-Use Designations (*Large Document -- Linked Directly to Federal Register Website)

2.  Notice: Government-Owned Inventions; Availability for Licensing

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

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

June 15, 2007

1.  Cyber Letters (updated 6/15/2007)

June 14, 2007

1.  Medication Guide for Soliris (eculizumab) (PDF, 6/14/2007)

2.  Drug Shortage; Drug to be Discontinued; Neutrexin (trimetrexate glucuronate) Injection (updated 6/14/2007)

June 13, 2007

1.  Drugs@FDA Downloadable Data Files (updated 6/13/2007)

June 12, 2007

1.  Public Workshop on Anthrax Vaccines - Bridging Correlates of Protection in Animals to Immunogenicity in Humans (Posted: 6/12/2007; Workshop Date: 11/8-9/2007)

2.  Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges (updated 6/12/2007)
     a.  Agenda [PDF]

3.  FDA Releases Human Tissue Task Force Report (Posted: 6/12/2007)

4.  Human Tissue Task Force - 2007 Report (Posted: 6/12/2007)

June 11, 2007

1.  BPCA/Pediatric Exclusivity Statistics:
     a.  Written Requests Issued (updated 6/11/2007)
     b.  Written Requests Statistics (updated 6/11/2007)
 

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

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

1.  KV Pharmaceutical Company (ClindesseTM (clindamycin phosphate) Vaginal Cream, 2%)

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