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

What do you really know about the sales and marketing resources supporting your competing drugs? Pharmaceutical and biotech companies throughout the world utilize PharmaForce's primary research process to analyze competitors, conduct successful product launches, restructure/expand/create functional departments, and allocate precious marketing resources.  (5% discount to www.PharmCast.com visitors)

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

http://www.pharmcast.com/PatentToSubWeb/Yr2006/Aug2006/Home080106OG.htm



1.  Method for biosynthesizing the serotonin derivatives in plants

2.  Cloned genome of infectious hepatitis C virus of genotype 2A and uses thereof

3.  Ocular solutions

4.  Method of treatment using interferon-tau

5.  Process for isolating genistin from mixtures of soy isoflavones

6.  Detection of HIV

7.  G-protein coupled receptors

8.  Ophthalmic pharmaceutical compositions and methods for treating ocular inflammation

9. Artemisinins with improved stability and bioavailability for therapeutic drug development and application

10.  Methods of treatment by administering an anti-BCMA antibody

11.  Epidermal growth factor agonists

12.  Method for treating glaucoma

13.  Antiviral substances from plant cuticular and epicuticular material

14.  Composition comprising a tramadol material and acetaminophen and its use

15.  Inactivated respiratory syncytial viral vaccines

16.  Fully human antibody Fab fragments with human interferon-gamma neutralizing activity

17.  Method of immunomodulatory treatment of insulin dependent diabetes mellitus using mycobacterial cell wall compositions

18.  Methods for enhanced retroviral-mediated gene transfer

19.  Tyrosine recombinase for genetic engineering

20.  Method to determine the risk for side effects of an SSRI treatment in a person

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

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

August 18, 2006

1.  Notice: Intent To Grant an Exclusive License of a U.S. Government-Owned Patent

2.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Marketing Act of 1987

August 17, 2006

1.  Notice: National Toxicology Program (NTP); Report on Carcinogens; Proposed Review Process for the 12th Report on Carcinogens (RoC): Request for Public Comment

2.  Notice: Draft Guidance for Industry; Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions; Availability

3.  Notice: Heparin Catheter Lock-Flush Solutions; Transfer of Primary Responsibility from Center for Drug Evaluation and Research to Center for Devices and Radiological Health

4.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; MedWatch--The Food and Drug Administration Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations

5.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mixups at Health Care Facilities--Survey

August 15, 2006

1.  Notice: Public Meeting of the President's Council on Bioethics on September 7-8, 2006

August 14, 2006

1.  Notice: Guidance for Industry on Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin G (IgG) Antibodies; Availability

2.  Notice: Draft Guidance for Industry on an Amendment Involving Donor Deferral for Transfusion in France Since 1980 to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products"; Availability

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

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

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

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

7.  Notice: Prospective Grant of Exclusive License: Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors

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

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

August 18, 2006

1.  Order to Cease Manufacturing and to Retain HCT/Ps - Donor Referral Services (Posted: 8/18/2006)

2.  Fiscal Year 2007 product and establishment fee invoices were mailed on August 15, 2006.  The payments for these invoices are due by October 1, 2006. PDUFA information (8/18/2006)

3.  BPCA/Pediatric Exclusivity Statistics
    a.  Written Request Template for Hepatitis B Drugs. (updated 8/18/2006)

August 17, 2006

1.  iSBTc Workshop on Combination Therapy for Cancer: Opportunities and Obstacles for Future Development - Slide Presentation (Posted: 8/17/2006)
    a.  FDA Perspectives on Combination Therapy of Cancer - Raj K. Puri, Ph.D., M.D.

August 16, 2006

1.  Drugs@FDA Downloadable Data Files (8/16/2006)

2.  Orange Book
    a.  Current Cumulative Supplement (PDF, 8/16/2006)
    b.  Information and Data Files (8/10/2006)
    c.  Additions/Deletions for Prescription and OTC Drug Product Lists, Number 7: July 2006 (updated 8/16/2006)

3.  Electronic Orange Book (EOB) Query data files:
    a.  EOBZIP.EXE (updated 8/16/2006)
    b.  EOBZIP.ZIP (updated 8/16/2006)

4.  Patient Information Sheets
    a.  Dacogen (decitabine) (8/16/2006)

August 15, 2006

1.  CDER Data Standards Manual: Potency Drug Nomenclature Monograph (updated 8/15/2006)

August 14, 2006

1.  Cellular, Tissue and Gene Therapies Advisory Committee Roster - Updated (Posted: 8/14/2006)

2.  Transmissible Spongiform Encephalopathies Advisory Committee Roster - Updated (Posted: 8/14/2006)

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