--------- May 20 - 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 5,600 people and serving a client base of over 250 global pharmaceutical and biotechnology companies.  Patheon offers development and manufacturing services in virtually all finished dosage forms with specialized expertise in liquid-filled hard capsules, high-potency, controlled-release and sterile manufacturing including aseptic filling and lyophilization.

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



 

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

1.  Current Good laboratory Practices & Current Good Manufacturing Practices-A Basic Primer, June 13-15, 2007, Costa Mesa, CA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=021&source=pharmcast
 

2.  Webinar: Intact Cell Mass Spectrometry for Microbe Identification and Recombinant Protein Analysis, May 22, 2007. Speaker: Mr. Martin Winkler, Consultant, The Biotech Advisor.  Organized by BenAstrum, Inc.

http://benastrum.com/10.html
 

3.  Global CNS Drugs Summit, May 30-31, 2007, Philadelphia, PA.  Organized by eyeforpharma.

http://www.eyeforpharma.com/cns2007/pharmcast
 

4.  The Breakfast Club – eyeforpharma Sales Force Effectiveness June 4, 2007, Princeton, NJ.  Organized by eyeforpharma.

http://www.eyeforpharma.com/breakfast
 

5.  Structure-Based Design: Sophisticated Approaches to Drug Discovery, June 6-8, 2007, Boston, MA.  Organized by Cambridge Healthtech Institute.

http://www.healthtech.com/2007/sbd
 

6.  PharmaBrand, June 11-13, 2007, Monte-Carlo, Monaco.  Organized by Marcus Evans.

http://www.pharmabrandeurope.com
 

7.  Optimising Clinical Trial Outsourcing and Creating Strategic Partnerships. June 14-15, 2007, London, UK.  Organized by C5.

http://www.c5-online.com/clinicaloutsourcing
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/May2007/Home050107OG.htm


1.  Methods for enhancing the efficacy of cytotoxic agents through the use of HSP90 inhibitors

2.  Polynucleotides encoding antigenic HIV type C polypeptides, polypeptides and uses thereof

3.  Methods of treating multiple myeloma and myeloma-induced bone resorption using integrin antagonists

4.  Composite materials for controlled release of water soluble products

5.  Enhancement of transfection of DNA into the liver

6.  Burn pain treatment by peripheral administration of a neurotoxin

7.  Conjugation of biomolecules using diels-alder cycloaddition

8.  Primitive neural stem cells and method for differentiation of stem cells to neural cells

9.  Methods for the reduction of stutter microsatellite amplification

10. Diagnostic markers of human female infertility

11.  Stable high-concentration injection containing pyrazolone derivative

12.  Synthetic human papilloma virus genes

13.  Composition for preventing and treating type I allergy

14.  Heat-generating composition for topical application to skin

15.  Liver engrafting cells, assays, and uses thereof

16.  Methods for treating ICACC protein associated diseases

17.  Recombinant vector expressing multiple costimulatory molecules and uses thereof

18.  Method for preventing ulceration or irritation of mucosa

19.  Stable liquid formulations of botulinum toxin

20.  DNA synthetase

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

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

May 18, 2007

1.  Notice: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL43, Request for Comments; Availability

2.  Notice: Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Controlled Lists of Terms

3.  Notice: C.W. Bill Young Cell Transplantation Program: National Cord Blood Inventory Related Cord Blood Donor Demonstration Project

May 17, 2007

1.  Notice: Foreign-Trade Zone 7 - - Mayaguez, Puerto Rico, Application for Temporary/Interim Manufacturing Authority, Merck Sharpe & Dohme Quimica De Puerto Rico, Inc., (Pharmaceutical Products), Caguas, Puerto Rico

2.  Notice: Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment to Byproduct Materials License No. 25-19852-01 For Unrestricted Release Of Building 7 of the Glaxosmithkline Biologicals-Hamilton Facility in Hamilton, MT

3.  Notice: National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); the Murine Local Lymph Node Assay: Request for Comments, Nominations of Scientific Experts, and Submission of Data

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

May 16, 2007

1.  Notice: Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Availability

2.  Notice: Draft Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs--Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information; Availability

3.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization

4.  Notice: Determination That MEPRON (Atovaquone) Tablets, 250 milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

May 14, 2007

1.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Data Bank

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

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

May 17, 2007

1.  Office of Generic Drugs: Generic Drug Petition Tracking Reports (Updated 5/17/2007)

May 16, 2007

2.  Drug Shortage: Drug to be Discontinued; Pulmicort Turbuhaler 200mcg (Updated 5/16/2007)

3.  Office of Generic Drugs: April First-Time Generic Drug Approvals (Updated 5/16/2007)

May 15, 2007

1.  Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (Posted 5/15/2007)

2.  Guidance for Industry: Labeling for Human Prescription Drugs -- Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information [PDF] (5/15/2007)

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

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

1.  Hollis J.C. Underwood, M.D. (BMIS Inspection)

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