--------- November 11 - 07 ---------

 

+++ BenAstrum's Pharmaceutical/Biotech Web Seminar Highlight+++

1.  November 21, 2007  “An All-Encompassing Look at Laboratory Information Management Systems (LIMS)”; Speaker: Bernice Russell-Bond; President, BRUSSELL Consulting  (Use promotional code PC1107 for 10% discount)

2.  November 28, 2007   “Good Documentation Practices Preface for the Pharmaceutical Laboratory”; Speaker: Kerry P. Potter; Founder, Summit Consulting Inc. (Use promotional code PC1107 for 10% discount)

3.  December 14, 2007   "A GMP Approach to the Detection, Correction and Prevention of Human Errors"; Speaker: Johnny Guerra, ex-FDA; President, Guerra Consulting Group Inc. (Use promotional code PC1207 for 10% discount)

http://benastrum.com/10.html

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

1.  ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development, January 7-9, 2008, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=090&source=pharmcast
 

2.  Web Seminar: Implementing a Robust Pharmaceutical Quality System; Part 2, November 27, 2007. (A Continuation of Part 1, “Defining Robust Pharmaceutical Quality Systems”)  Speaker: Calvin Koerner, Ex-FDA President, I.Q. Auditing.  Organized by BenAstrum, Inc. (Use promotional code PC1107 for 10% discount).

http://benastrum.com/10.html
 

3.  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
 

4.  12th Annual Drug & Medical Device Litigation, December 12-14, 2007, New York, NY.  Organized by American Conference Institute.

http://www.drugandmed.com/
 

5.  US FDA Biological Approval Process, December 13-14, 2007, Beijing (in Mandarin); January 14-15, 2008, Seoul (In English); January 17-18, 2008, Taipei (In English).  Organized by IBC Shanghai.

http://www.ibcchina.com.cn/fdaapproval
 

6.  Utilizing Biomarkers to Determine Optimal Dose, January 14-15, 2008, Philadelphia, PA.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=92
 

7.  3rd Annual Clinical Data Disclosure Summit, January 14-15, 2008, Arlington, VA.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=94n
 

8.  3rd Annual Pharma Pricing Strategies, January 15-16, 2008, Rome, Italy.  Organized by Jacob Fleming Conferences.

http://www.jacobfleming.com/buxus/generate_page.php?page_id=968



 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Oct2007/Home102307OG.htm


1.  Hyperthermic inducible expression vectors for gene therapy and methods of use thereof

2.  Oligodendrocytes derived from human embryonic stem cells for remyelination and treatment of spinal cord injury

3.  Mucin peptide with immunoenhancing properties

4.  Use of nitroxides in treating skin disease

5.  Tropomyosin isoforms, and diagnostic and therapeutic uses therefor

6.  Treatment of melanoma by reduction in clusterin levels

7.  Antibodies against gene products related to Werner's Syndrome

8.  Nanoparticle vaccines

9.  Antigenic composition comprising an HIV gag or env polypeptide

10.  Warming and nonirritating lubricant compositions and method of comparing irritation

11.  Herbal chemical composition for the treatment of cancer

12.  PRO536 polypeptides

13.  Transmucosal oral delivery device

14.  Pharmaceutical compositions containing lactobacilli for treatment of vaginal infections and related method

15.  Absorbent polymer compositions, medical articles, and methods

16.  Gene repair involving in vivo excision of targeting DNA

17.  Methods for identification of alport syndrome

18.  Method of obtaining biologically active collagen from skins of the salmonidae fish

19.  Tumor radiosensitization using gene therapy

20.  Mutant forms of cholera holotoxin as an adjuvant

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

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

November 9, 2007

1.  Notice: Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Availability

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

3.  Notice: Agency Emergency Processing Under Office of Management and Budget Review; Orphan Drug Products; Common European Medicines Evaluation Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation

4.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program

November 8, 2007

1.  Proposed Rule: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (*Large Document, Linked Directly to Federal Register Website)

2.  Proposed Rule: Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine); Public Meeting; Extension of Comment Period

November 7, 2007

1.  Notice: Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications

2.  Notice: Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections

November 5, 2007

1.  Notice: Adolescent Over-the-Counter Drug Product Use; Public Workshop

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

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

November 9, 2007

1.  Drug Shortage
     a.  Drug to be Discontinued; Procanbid (Procanamide Hydrochloride Extended-Release Tablets) (11/9/2007)

2.  Biological Product Shortages - Haemophilus b Conjugate Vaccine (PedvaxHIB) information (Posted: 11/9/2007)

3.  Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications (Posted 11/9/2007)

November 8, 2007

1.  Drug Approval Reports (Updated 11/9/2007)
     a.  Fast Track Fiscal Year 2007
     b.  Fast Track Designation (FY 1998 - FY 2006)
     c.  NDA and BLA Approvals
     d.  NME Drug and New Biologic Approvals
     e.  Priority NDA and BLA Approvals

2.  FDA strengthens the Boxed Warnings and approves other safety labeling changes for erythropoiesis-stimulating agents (ESAs). [FDA News]; [Public Health Advisory]; [Information for Healthcare Professionals] (11/8/2007)

3.  Guidance for Industry: Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment [PDF] or [HTML] (11/8/2007)

4.  Background Information Regarding the ISBT Label - Updated (Posted: 11/8/2007)

5.  Compliance Program: Chapter 41 - Inspection of Tissue Establishments - Updated (Posted: 11/8/2007)

6.  FEDERAL REGISTER: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Proposed Rule (Posted 11/8/2007)

November 7, 2007

1.  Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update (Posted: 11/7/2007)

November 6, 2007

1.  Approved Biological NDA and ANDA Applications - Update (Posted: 11/6/2007, Updated through: 10/31/2007)

2.  Cleared Biological 510(k) Device Applications - Update (Posted: 11/6/2007, Updated through: 10/31/2007)

3.  Approved Biological Premarket Approval (PMA) Device Applications - Update (Posted: 11/6/2007, Updated through: 10/31/2007)

4.  Drug Approval Reports (Updated 11/6/2007)
     a.  NDA and BLA Approvals
     b.  NME Drug and New Biologic Approvals
     c.  Priority NDA and BLA Approvals

November 5, 2007

1.  Tissue Reference Group Annual Reports - FY 2007 Update (Posted: 11/5/2007)

2.  Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - Agenda (Posted: 11/5/2007)

3.  FDA requests the marketing suspension of Trasylol (aprotinin) (11/5/2007)

4.  Guidance for Industry: Comprehensive List of Guidance Documents [PDF] (Updated 11/5/2007)

5.  Guidance for Industry: New/Revised/Withdrawn List for 2007 [PDF] (Updated 11/5/2007)
 

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

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

1.  Scios, Inc. (Natrecor© (nesiritide) for Injection)

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