--------- April 1 - 07 ---------

 

+++ PharmCast.com's Pharmaceutical Business Intelligence Studies Highlight +++

What do you really know about the sales and marketing resources supporting your competing drugs? Pharmaceutical and biotech companies throughout the world utilize PharmaForce's primary research process to analyze competitors, conduct successful product launches, restructure/expand/create functional departments, and allocate precious marketing resources.  (5% discount to www.PharmCast.com visitors)

http://www.pharmcast.com/BuyersGuide/Software/PharmBusIntellStudies.htm

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

1.  Agitator Design Principles, April 26-27, 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=003&source=pharmcast
 

2.  2nd RFID Solutions Expo & Conference in Tokyo (RIDEX), May 16-18, 2007, Tokyo, Japan.  Organized by Reed Exhibitions Japan.

http://www.ridex.jp/ridex/en/
 

3.  Clinical Trial Agreements & Budgets Conference, May 20-23, 2007, Atlantic City, NJ.  Organized by iiBIG.

http://www.iibig.com/P0703
 

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

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

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

 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Mar2007/Home031307OG.htm


1.  Method of in vitro preconditioning healthy donor's myoblasts before transplantation thereof in compatible patients suffering of myopathies like muscular dystrophy, for improving transplantation success

2.  Peptide/lipid complex formation by co-lyophilization

3.  Analysis of gene expression profiles using sequential hybridization

4.  Cancerous disease modifying antibodies

5.  Live vaccine for human immunodeficiency virus

6.  Drug delivery of proteins from polymeric blends

7.  Botulinum toxin production method

8.  Human gene critical to fertility

9.  Methods of treatment with antagonists of MU-1

10.  Rapidly disintegrable pharmaceutical composition

11.  Production of adenovirus vectors with reduced levels of replication competent adenovirus contamination

12.  Antiseptic composition

13.  Humanized antibodies that recognize beta amyloid peptide

14.  Oncosuppressive gene

15.  Soluble CD40L(CD154) as a prognostic marker of atherosclerotic diseases

16.  Nanometer-sized carrier medium

17.  Oligoribonucleotides alert the immune system of animals to the imminence of microbial infection

18.  Secreted and transmembrane polypeptides and nucleic acids encoding the same

19.  Method and pharmaceutical compositions for treating or inhibiting renal dysfunctions, diseases or disorders, particularly in diabetic patients

20.  Tumor vessel endothelial cell-binding monoclonal antibodies

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

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

March 30, 2007

1.  Proposed Rule: Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Reopening of the Comment Period

2.  Notice: Draft Guidance for Industry and Review Staff on Target Product Profile--A Strategic Development Process Tool; Availability

3.  Notice: Alcan Global Pharmaceutical Packaging, Inc.; Plastics American Division; Centralia, IL; Notice of Negative Determination on Remand

March 29, 2007

1.  Final Rule: Laxative Drug Products for Over-the-Counter Human Use; Psyllium Ingredients in Granular Dosage Forms

2.  Notice: Workshop to Discuss Development of a Women's Health Information Sharing Network

March 28, 2007

1.  Notice: List of Drugs for Which Pediatric Studies Are Needed

2.  Notice: Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop

3.  Notice: Secretary's Advisory Committee on Genetics, Health, and Society

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

5.  Notice (B): Government-Owned Inventions; Availability for Licensing

6.  Notice (C): Government-Owned Inventions; Availability for Licensing

7.  Notice: Grant of Authority for Subzone Status, Medline Industries, Inc., (Medical Supply Distribution), Lathrop, California

March 26, 2007

1.  Notice: Determination That DURICEF (Cefadroxil USP) Tablets, 1 Gram, and Capsules, 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

2.  Notice: Determination of Regulatory Review Period for Purposes of Patent Extension; REVLIMID

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

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

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

March 30, 2007

1.  Office of Generic Drugs:
     a.  FDA solicits comments on Amlodipine Abbreviated New Drug Application Approval issues (3/30/2007)

2.  New or Updated Patient Information sheets for:
     a.  Invega (paliperidone) (3/30/2007)

March 29, 2007

1.  Guidance for Industry and Review Staff : Target Product Profile -- A Strategic Development Process Tool [PDF] or [HTML] (3/29/2007)

2.  FDA announces a voluntary withdrawal of Permax and generic pergolide products which are used to treat Parkinson’s disease. Pergolide Information (3/29/2007)

3.  FDA launches a web page warning against buying Accutane and its generic versions online. FDA News (3/29/2007)

4.  Office of Nonprescription Products:
     a.  Rulemaking History for Nonprescription Products (3/29/2007)

March 28, 2007

1.  Letter: Hanson Meditech (Posted: 3/28/2007)

2.  CDER Organization Charts [HTML] [PDF] (updated 3/28/2007)

3.  New or Updated Patient Information sheets for:
     a.  Keppra (levetiracetam)(3/28/2007)
     b.  Omnaris (cirlesonide)(3/28/2007)

March 27, 2007

1.  The Adverse Event Reporting System (AERS) Latest Quarterly Data Files (3/27/2007)

2.  International Conference on Harmonization (ICH) Public Meeting Friday, April 6, 2007, Rockville, MD. Meeting Information (3/27/2007)

3.  "Dear Healthcare Professional Letter" for Ketek (telithromycin) issued by Sanofi-aventis. MedWatch Information (3/27/2007)

4.  Cyber Letters (updated 3/27/2007)

5.  Biological Product and HCT/P Deviation Reports - Annual Summary for FY 2006 (Posted: 3/27/2007)

March 26, 2007

1.  Draft Guidance for Industry and FDA Staff: Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (Posted 3/26/2007)

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