--------- August 26 - 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.  Stability Testing of Proteins, Peptides & Other Biomolecules, September 24-25, 2007, Costa Mesa, CA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=098&source=pharmcast
 

2.  Web Seminar: Responding to 483s; GapAnalysis on a Validation Documentation System, September 11, 2007.  Speaker: Kendall Young, PhD.; President, Blue Sea Consulting.  Organized by BenAstrum, Inc. (Use promotional code PC0907 for 10% discount)

http://benastrum.com/10.html
 

3.  Global Outsourcing of Clinical Trials, November 8-9, 2007, New Jersey.  Organized by Arrowhead Conferences.

http://www.arrowheadpublishers.com/conferences/outsourcingclinicaltrials/index.php
 

4.  3rd Pharmaceutical Sampling Strategies, November 8-9, 2007, Philadelphia, PA.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=82
 

5.  e-Communication and Online Marketing 2007, November 12-13, 2007, Philadelphia, PA.  Organized by eyeforpharma.

http://www.eyeforpharma.com/ecomm2007/3
 

6.  NanoBiotech World Congress, November 13-14, 2007, Boston, MA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/nanobiotech2007/
 

7.  Advances in Metabolic Profiling, November 13-14, 2007, Boston, MA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/amp2007/
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Aug2007/Home080707OG.htm


1.  Identification of etiology of autism

2.  Polynucleotide encoding a mutated HIV gp41 polypeptide

3.  Methods for sterilizing preparations containing albumin

4.  Methods and compositions for correction of cardiac conduction disturbances

5.  Cysteine variants of interleukin-11

6.  Topical composition and method for the treatment and prophylaxis of dermal irritations

7.  Method of generating neurons from stem cells and medium for culturing stem cells

8.  Delivery system and a manufacturing process of a delivery system

9.  Anti-neovasculature preparations for cancer

10.  Compounds and methods for modulating cell-adhesion mediated drug resistance

11.  Complementarity determining region-grafted antibody against ganglioside GD3 and derivative of antibody against ganglioside GD3

12.  Methods for treating post-surgical pain by administering an anti-nerve growth factor antagonist

13.  Induced phase transition method for the production of microparticles containing hydrophilic active agents

14.  Highly purified mocarhagin, a cobra venom protease, polynucleotides encoding same and related proteases, and therapeutic uses thereof

15.  Compositions and methods for detecting and treating diseases and conditions related to chemokine receptors

16.  Gene delivery vehicle expressing the aptosis-inducing proteins VP2 and/or apoptin

17.  Assays for diagnosis of thrombophilic disease

18.  Elastin stabilization of connective tissue

19.  Topical acne vulgairs medication with a sunscreen

20.  Method for separating and purifying a nucleic acid

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

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

August 24, 2007

1.  Notice: "Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV;" Availability

2.  Final Rule: Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (``Lookback''); Final Rule (*Large Document, Linked Directly to Federal Register Website)

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

4.  Notice: Agency Information Collection Activities: Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

5.  Notice: Controlled Substances: Final Revised Aggregate Production Quotas for 2007

6.  Notice: Controlled Substances: Proposed Aggregate Production Quotas for 2008

August 23, 2007

1.  Notice: Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Disease Laboratory, Boston University Medical Center

2.  Interim Final Rule: Disclosure of Information to Organ Procurement Organizations

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

August 22, 2007

1.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Broadcast Advertisements

August 20, 2007

1.  Notice: Medical Devices 101: An Educational Forum; Public Workshop

2.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions; Extension

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

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

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

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

August 24, 2007

1.  Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications (Posted 8/24/2007)

2.  FEDERAL REGISTER: Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection ("Lookback"); Final Rule (Posted 8/24/2007)

3.  Guidance for Industry: "Lookback" for Hepatitis C Virus (HCV):Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV (Posted 8/24/2007)

August 23, 2007

1.  FDA proposes a new rule for sunscreen products to include a new UVA rating system and sun warning information. FDA News (8/23/2007)

2.  Drugs@FDA Downloadable Data Files (updated 8/23/2007)

August 22, 2007

1.  Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update (Posted: 8/22/2007)

2.  FDA approves Risperdal (risperidone) for two psychiatric conditions in children and adolescents. FDA News (8/22/2007)

August 21, 2007

1.  Cyber Letters (updated 8/21/2007)

2.  Manuals of Policies and Procedures (MaPP) 6050.1R Refusal to Accept Application for Filing From Applicants in Arrears (updated 8/21/2007)

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

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

1.  Ames Periodontal Specialists (BMIS Inspection)

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