--------- July 22 - 07 ---------

 

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

Patheon provides integrated dosage form development and contract manufacturing services from a network of 14 facilities in Europe and North America, employing more than 5,000 people and serving a client base of more than 250 global pharmaceutical and biotechnology companies.  Patheon offers development, manufacturing and packaging services in virtually all finished dosage forms with specialized expertise in liquid-filled hard capsules, high-potency, controlled-release, disposable technologies, biopharmaceuticals and sterile manufacturing including aseptic filling and lyophilization.

http://www.pharmcast.com/BuyersGuide/Patheon/PatheonComInfo.htm

+++ CfPIE's Pharmaceutical/Biotech Training Courses Highlight+++

1.  Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Manufacturers of Cosmetics and OTC Drug Products, August 9 & 10, 2007, Malvern, PA

http://www.cfpie.com/showitem.aspx?productid=037&source=pharmcast
 

2.  How to Monitor Clinical Trials for GCP Compliance, August 21 & 22, 2007, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=043&source=pharmcast
 

3.  Environmental, Health & Safety (EHS) Issues in the Pharmaceutical and Medical Device Industries, September 9 & 10, 2007, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=105&source=pharmcast
 

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

1.  Web Seminar: A Quality System Approach to Technology Transfer in the Pharmaceutical Industry July 30, 2007. Speaker: Dr. Frank S. Kohn President, FSK Associates Inc.  Organized by BenAstrum, Inc.  Use promotional code PC0707 for 10% discount.

http://benastrum.com/10.html
 

2.  Evolution Summit, October 17-19, 2007, Monte-Carlo, Monaco.  Organized by Marcus Evans.

http://www.evolution-summit.com
 

3.  Medicare Special Needs Plans - Year 3, October 22-23, 2007, Arlington, VA.  Organized by Financial Research Associates.

http://www.frallc.com/conference.aspx?ccode=b509
 

4.  Global Pharma R&D Summit, October 22-23, 2007, Boston, MA.  Organized by World Trade Group.

http://www.globalpharmasummit.com
 

5.  2nd Annual Pharma Talent Management, October 23-24, 2007, Brussels, Belgium.  Organized by Jacob Fleming Conferences.

http://www.jacobfleming.com/buxus/generate_page.php?page_id=554
 

5.  Maximizing Pharmaceutical Patent Life Cycles, October 24-25, 2007, New York, NY.  Organized by American Conference Institute.

http://www.americanconference.com/Pharmaceuticals_Biotech_Life_Sciences/lifecyclesNYC.htm
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/July2007/Home070307OG.htm


1.  Method of treatment of osteoporosis with compositions of red rice fermentation products

2.  PRO1313 polypeptides

3.  Strategy for leukemia therapy

4.  Means and methods for fibroblast-like or macrophage-like cell transduction

5.  High capacity recombinant adenoviral vector for treatment of hemophilia A

6.  Silica mesoporous aerogels having three-dimensional nanoarchitecture with colloidal gold-protein superstructures nanoglued therein

7.  Methods for treating ulcers and gastroesophageal reflux disease

8.  Monoclonal antibody cPAM4

9.  Prostate cancer cell lines

10.  Black tea extract for prevention of disease

11.  Submicron liposome suspensions obtained from preliposome lyophilizates

12.  Method for predicting tumor recurrence

13.  TNF binding proteins

14.  Topical compositions for veterinary uses

15.  Multifunctional biocompatible hydrophilic gel and the method of gel manufacture

16.  Compounds and methods for immunotherapy and diagnosis of tuberculosis

17.  System and method for the large scale labeling of compounds with radiohalogens

18.  Direct assay of cholesterol in skin samples removed by tape stripping

19.  Methods for delivering DNA to muscle cells using recombinant adeno-associated virus vectors

20.  Triggered release from proteinoid microspheres

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

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

July 20, 2007

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

July 19, 2007

1.  Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Premarket Notification Submissions for Medical Devices That Include Antimicrobial Agents; Availability

2.  Notice: Determination That Brethine (Terbutaline Sulfate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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

4.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products

July 17, 2007

1. Final Rule: Medicaid Program; Prescription Drugs (*Large Document, Linked Directly to Federal Register Website)

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

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

July 20, 2007

1.  Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (Posted 7/20/2007)

July 19, 2007

1.  Drugs@FDA Downloadable Data Files (updated 7/19/2007)

July 18, 2007

1.  Manual of Policies and Procedures (MaPP) 6020.3R Priority Review Policy (7/18/2007)

July 17, 2007

1.  Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts (Posted: 7/17/2007, Workshop Dates: 10/11-12/2007)

July 16, 2007

1.  Manual of Policies and Procedures (MaPP) Procedures for Post-Approval Commitment Tracking in the Office of Generic Drugs [5200.11] (7/16/07)

2.  Manual of Policies and Procedures (MaPP) Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products [6020.5R] (7/16/07)
 

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

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

1.  Doak Dermatologics (Solaraze (diclofenac sodium) Gel, 3 %)

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