--------- October 21 - 07 ---------

 

+++ PharmCast.com's Company Highlight +++

Covidien Pharmaceuticals Outsourcing (formerly Mallinckrodt Pharmaceuticals Outsourcing) -- Mallinckrodt and its former parent company, Tyco/Healthcare, are now Covidien, a $10 billion global leader in pharmaceuticals, medical devices/ supplies, diagnostic imaging agents, and other healthcare products and services.  As part of Covidien, we are better positioned than ever to give your contract manufacturing product the high level of accountability and attention it deserves.  Our focus continues to be long-term partnerships providing responsive and flexible service to manufacture your solid dose and oral liquid products -- on time and within budget.

http://www.pharmcast.com/BuyersGuide/Mallinckrodt/MallinckrodtComInfo.htm

 

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

1.  Reporting Failure Investigations & Process Deviations, November 12-14, 2007, King of Prussia, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=068&source=pharmcast
 

2.  Web Seminar: Change Control under the cGMP’s and fGMP’s, for the 21st Century October 30, 2007. Speaker: Charles Levine, Industry Consultant President, Levine Pharmaceutical Consulting Inc.  Organized by BenAstrum, Inc.  Use promotional code PC1007 for 10% discount.

http://benastrum.com/10.html
 

3.  Clinical Project Management (Intermediate- Advance), November 1-2, 2007, Beijing, China.  Organized by Marcus Evans.

http://www.marcusevans.com/html/eventdetail.asp?eventID=12656&SectorID=31&divisionID
 

4.  The 3rd Pharmaceutical Meeting Planners Summit, November 5-6, 2007, Princeton, NJ.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=79
 

5.  Clinical Project Management (Intermediate- Advance), November 5-6, 2007, Taipei, Taiwan.  Organized by Marcus Evans.

http://www.marcusevans.com/html/eventdetail.asp?eventID=12657&SectorID=31&divisionID
 

6.  Pediatric Clinical Trials, November 5-6, 2007, Arlington, VA.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=87
 

7.  Pharma Sales World 2007: Advanced Sales Force Remodelling Strategies in a Multi-Channel Environment, November 5-7, 2007, Prague, Czech Republic.  Organized by Worldwide Business Research.

http://www.pharmasalesworld.com
 

8.  3rd MSL Next Practices, November 8-9, 2007, Orlando, FL.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=84
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Oct2007/Home100207OG.htm


1.  Transgenic animals, cell lines derived therefrom, and methods for screening for anti-amyloidogenic agents

2.  Tissue glue with improved antiadhesive properties

3.  Nucleic acid-containing complex

4.  Methods of treating neoplasia with combinations of target cell-specific adenovirus and chemotherapy

5.  Sustained release formulations of oxymorphone

6.  Methods and compositions for the treatment of pancreatitis

7.  Nanoparticulate fibrate formulations

8.  Vector system

9.  Method of acquiring immunological tolerance

10.  Dissolvable backing layer for use with a transmucosal delivery device

11.  Chimeric and humanized antibodies to .alpha.5.beta.1 integrin that modulate angiogenesis

12.  Designing compounds specifically inhibiting ribonucleic acid function

13.  Method and composition for treatment of skeletal dysplasias

14.  Trans-scleral drug delivery method and apparatus

15.  Small peptides for the treatment of Alzheimer's disease and other beta-amyloid protein fibrillogenesis disorders

16.  Mutated Src oncogene composition and methods

17.  Intratesticular injection of chemical sterilant

18.  Immunogenic proteoliposomes, and uses thereof

19.  Methods of treating intestinal ischemia using heparin-binding epidermal growth factor

20.  Plus end-directed microtubule motor required for chromosome congression

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

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

October 19, 2007

1.  Final Rule: Medical Devices; General Hospital and Personal Use Devices; Classification of Remote Medication Management System

2.  Notice: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System; Availability

3.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Data Bank

October 18, 2007

1.  Direct Final Rule: Revision of the Requirements for Live Vaccine Processing

2.  Proposed Rule: Revision of the Requirements for Live Vaccine Processing; Companion to Direct Final Rule

3. Final Rule: Applications for Food and Drug Administration Application Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements

4.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Special Protocol Assessment

October 17, 2007

1.  Notice: Notice of Environmental Assessment Related to the Issuance of a License Amendment to Byproduct Material License No. 21-26519-01, for Unrestricted Release of Former Facilities for Aastrom Biosciences, Ann Arbor, MI

2.  Notice: Prospective Grant of Exclusive License: Adult Human Dental Pulp Stem Cells, Postnatal Stem Cells, and Multipotent Postnatal Stem Cells From Human Periodontal Ligament

3.  Notice: Prospective Grant of Exclusive License: Treatment of Proliferative Disorders Using an Unexpected mTOR Kinase Inhibitor

October 16, 2007

1.  Notice: Training Program for Regulatory Project Managers; Information Available to Industry

2.  Notice: Grant of Interim Extension of the Term of U.S. Patent No. 4,971,802; MIFAMURTIDE

October 15, 2007

1.  Notice: Draft Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval; Availability

2.  Notice: Draft Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability

3.  Notice: Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application; Availability

4.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration

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

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

October 19, 2007

1.  Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update (Posted: 10/19/2007)

2.  Paragraph IV Patent Certifications (updated 10/19/2007)

October 18, 2007

1.  Guidance for Industry: The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP) [PDF] or [HTML] (Updated 10/18/2007)

2.  FDA issues questions and answers for Viagra, Levitra, Cialis, and Revatio on possible sudden hearing loss (10/18/2007)

3.  FDA approves Doribax (doripenem), a new drug to treat complicated urinary tract and intra-abdominal infections (10/18/2007)

4.  FDA approves Isentress (raltegravir), a new drug to treat HIV infection (10/18/2007)

5.  FDA Expands Age Range for Use of Bacterial Meningitis Vaccine (Posted 10/18/2007)

6.  Letter: Coagulation Factor IX (Human) (Mononine) - CSL Behring LLC (Posted: 10/18/2007)

7.  FEDERAL REGISTER: Revision of the Requirements for Live Vaccine Processing; Direct Final Rule (Posted: 10/18/2007)
    a.  FEDERAL REGISTER:Revision of the Requirements for Live Vaccine Processing; Companion to Direct Final Rule; Proposed Rule (Posted: 10/18/2007)

8.  Bioresearch Monitoring Information System (BMIS) download file (Updated 10/18/2007)

9.  Drug Approval Report: Accelerated Approvals (Updated 10/18/2007)

October 17, 2007

1.  Office of Generic Drugs: First-Time Generic Drug Approvals (updated 10/17/2007)

October 16, 2007

1.  AERS Quarterly Download, 2nd Quarter 2007 (updated 10/16/2007)

2.  FDA issues an FDA Alert and Healthcare Professional Sheet for Exenatide (10/16/2007)

3.  Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 10/16/2007)

October 15, 2007

1.  ISCT 7th Annual Somatic Cell Therapy Symposium - 9/26-28/2007 (Posted: 10/15/2007)
    a.  Facility and Operational Issues for Cord Blood Banks: FDA Draft Guidance (PDF - 276 KB) - Mary Malarkey

2.  FDA Acronyms Search (updated 10/15/2007)

3.  SOPP 8205: Emergency INDs (Posted: 10/15/2007)

4. SOPP 8113: Handling of Regulatory Faxes (Posted: 10/15/2007)

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