--------- November 18 - 07 ---------

 

+++ PharmCast.com's Pharmaceutical and Biotech Resources +++

http://www.pharmcast.com/BuyersGuide/PharmResources.htm


Pharmaceutical and Biotech Outsourcing Guide:
    • Agilent Technologies
    • HNC Products
    • Mallinckrodt Pharmaceuticals Outsourcing
    • Patheon
    • Waypharm SAS

Pharmaceutical Training, Software, Studies and Database:
    • Pharmaceutical and Biotech Training Courses
    • Pharmaceutical and Biotech Web Seminars
    • Pharmaceutical Operation Software
    • Pharmaceutical Business Intelligence Studies

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

1.  Effective Document Management for the Pharmaceutical, Biotech and Medical Device Industries, January 8-9, 2008, Costa Mesa, CA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=027&source=pharmcast
 

2.  Web Seminar: FDA Compliance for Network Infrastructure November 29, 2007. Speaker: Bernice Russell-Bond, President, BRUSSELL Consulting Inc.  Organized by BenAstrum, Inc. (Use promotional code PC1007 for 10% discount).

http://benastrum.com/10.html
 

3.  12th Annual Pharma & Biotech Licensing Deal Making Summit (with Asia Partnering track), December 10-11, 2007, La Jolla, CA.  Organized by Strategic Research Institute.

http://www.almevents.com/conf_page.cfm?instance_id=27&web_id=918&pid=525
 

4.  3rd Annual Marketing & Sales in GENERICS, January 17-18, 2008, Barcelona, Spain.  Organized by Jacob Fleming Conferences.

http://www.jacobfleming.com/buxus/generate_page.php?page_id=823
 

5.  India Contract Manufacturing 2008, January 21-22, 2008, Mumbai, India.  Organized by Marcus Evans.

http://www.marcusevans.com/events/CFEventinfo.asp?EventID=12826
 

6.  Advertising & Promotions for the Pharmaceutical Industry, January 22-23, 2008, New York, NY.  Organized by American Conference Institute.

http://www.americanconference.com/pharmaad
 

7.  Partnerships with Sites, January 23-25, 2008, Lake Buena Vista, FL.  Organized by the Institute for International Research.

http://www.iirusa.com/sites
 

8.  4th Annual Pediatric Clinical Trials, January 28-29, 2008, Washington D.C.  Organized by Marcus Evans.

http://www.marcusevansbb.com/pediatrictrials



 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Oct2007/Home103007OG.htm


1.  Method for monitoring early treatment response

2.  Fully human antibodies against human 4-1BB

3.  Treatment of holocrine gland dysfunction with clostridia neurotoxins

4.  Growth factor therapy mobilization of stem cells into the peripheral blood

5.  Biosynthetic gene cluster for leptomycins

6.  Aerosol drug inhibition of lung metastases

7.  Method and device for determining distribution of glycation of erythrocytic membranes

8.  Use of immunotoxins to induce immune tolerance to pancreatic islet transplantation

9.  Asafetida extract as medicine for abstinence of drugs

10.  Cellular genes regulated by HIV-1 infection and methods of use thereof

11.  Cryptosporidium parvum antigens, antibodies thereto and diagnostic and therapeutic compositions thereof

12.  Methods for structural analysis of proteins

13.  Therapeutic composition for the prevention and treatment of mucositis and mucosal disorders

14.  Bioadhesive nanoparticulate compositions having cationic surface stabilizers

15.  Chlorogenic acid and an analog thereof for immune system stimulation

16.  Peptide-forming enzyme gene

17.  Liposome complexes for increased systemic delivery

18.  Sphingomyelin enhancement of tumor therapy

19.  Solution for the preservation of hearts

20.  Potent inhibition of influenza virus by specifically designed short interfering RNA

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

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

November 16, 2007

1.  Notice: Notice of Extension of Public Comment Period for the External Review Draft of a "Framework for Determining a Mutagenic Mode of Action for Carcinogenicity: Using EPA's 2005 Cancer Guidelines and Supplemental Guidance for Assessing Susceptibility From Early-Life Exposure to Carcinogens"

November 15, 2007

1.  Notice: Prospective Grant of Exclusive License: Use of Licensed Patent Rights for Development of Therapies for Prostatic Diseases

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

November 14, 2007

1.  Final Rule: Oral Dosage Form New Animal Drugs; Chlortetracycline Powder

November 13, 2007

1.  Notice: National Toxicology Program (NTP); Report on Carcinogens (RoC); Availability of the Draft Background Documents for Aristolochic Acid Related Exposures (Two Candidate Substances: Botanical Products Containing Aristolochic Acid and Aristolochic Acid) and Riddelliine and Request for Public Comment on the Draft Background Documents; Announcement of the Aristolochic Acid Related Exposures and Riddelliine Expert Panel Meeting

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

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

November 16, 2007

1.  Manuals of Policies and Procedures (MaPPs) (updated 11/16/2007)
    a.  Acceptability of Standards From Alternative Compendia [PDF]
    b.  Classifying Resubmissions of Original NDAs, BLAs, and Efficiacy Supplements in Response to Action Letters [PDF]

2.  Office of Generic Drugs: October First-Time Generic Drug Approvals (11/16/2007)

3.  Paragraph IV Patent Certifications (updated 11/16/2007)

November 15, 2007

1.  FDA informs healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. MedWatch Safety Information (11/15/2007)

2.  BPCA/Pediatric Exclusivity Statistics:
    a.  Pediatric Exclusivity Granted (updated 11/15/2007)
    b.  Pediatric Exclusivity Labeling Changes (updated 11/15/2007)

3.  Drugs@FDA Downloadable Data Files (updated 11/15/2007)

November 14, 2007

1.  FDA issues an Information for Healthcare Professionals sheet for Viagra, Levitra, and Cialis (11/14/2007)

2.  FDA issues an Early Communication About an Ongoing Safety Review for Cefepime (marketed as Maxipime) (11/14/2007)

3.  Drug Approval Reports (updated 11/14/2007)
    a.  NDA and BLA Approvals
    b.  NME Drug and New Biologic Approvals
    c.  Priority NDA and BLA Approvals

4.  DOD 2007 Biodefence Conference - 11/07/2007 (Posted 11/14/07)
    a.  FDA/CBER’s Role in Facilitating Development of and Access to Medical Countermeasures (PDF - 352 KB) - Cynthia Kelly

5.  Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update (Posted: 11/14/2007)

November 13, 2007

1.  Drug Approval Reports: Efficacy Supplement Approvals (11/13/2007)

2.  Electronic Human Cell and Tissue Establishment Registration (eHCTERS) Instructions - Updated (Posted: 11/13/2007)

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