Date:
Fri, April 13, 2007 10:03:05 PMFrom:
PharmCast Dot Com
Subject:
PharmCast.com's Official Newsletter, April 15, 2007
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P H A R M C A S T D O T C O M
The www.PharmCast.com Official
Newsletter
--------- April 15 - 07 ---------
+++ PharmCast.com's Healthcare MBA Program Highlight+++
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+++ PharmCast.com's Conference Highlight
+++
1. Project Management for the Phase 3 and LCM (Life Cycle Management), May 2-3, 2007, Malvern, PA. Organized by The Center for Professional Innovation & Education.
http://www.cfpie.com/showitem.aspx?productid=101&source=pharmcast
2. BioPharma OUTSOURCING: From Case Study to Coherent Strategy, July 11-12, 2007, Atlantic City, NJ. Organized by iiBIG.
3. European Biomarkers Summit, September 4-5, 2007, Amsterdam, Netherlands. Organized by Select Biosciences Ltd.
http://www.selectbiosciences.com/conferences/EBS2007/index.aspx
4. Proteomics Europe, September 4-5, 2007, Amsterdam, Netherlands. Organized by Select Biosciences Ltd.
http://www.selectbiosciences.com/conferences/proteomicseurope2007/index.aspx
5. Screening Targets, September 10-11, 2007, Boston, MA. Organized by Select Biosciences Ltd.
http://www.selectbiosciences.com/conferences/ScreeningTargets/
6. Ion Channel Targets, September 10-11, 2007, Boston, MA. Organized by Select Biosciences Ltd.
http://www.selectbiosciences.com/conferences/ICT2007/
+++ PharmCast.com's Last Week
Pharmaceutical Patents +++
http://www.pharmcast.com/PatentToSubWeb/Yr2007/Mar2007/Home032707OG.htm
1. Protection of the female reproductive system from natural and
artificial insults
2. Enveloped virus vaccine and method for production
3. Compositions for electroporation
4. Methods and compositions for screening of human borna disease virus
5. Transgenic animal containing CD200 and uses therefor
6. Method and kit for following neurodegenerative diseases
7. Implantable and sealable system for unidirectional delivery of therapeutic agents to tissues
8. Product and process for liquefaction of mucus or sputum
9. Drug response marker in beta-1 adrenergic receptor gene
10. High molecular weight polysaccharide fraction from Aloe vera with immunostimulatory activity
11. Methods for the treatment of thrombosis
12. Antibodies to JTT-1 protein and cells secreting such antibodies
13. Drug delivery system for zero order, zero order-biphasic, ascending or descending drug delivery
14. Treatment of human multiple myeloma by curcumin
15. Measurement and use of molecular interactions
16. Amino-acid iodine complex
17. Prophylactic and therapeutic treatment of the ductal epithelium of a mammary gland for cancer
18. Nanoparticle delivery system
19. Methods and compositions for screening for angiogenesis modulating compounds
20. Diagnosis of diseases associated with gene regulation
+++ PharmCast.com's Last Week Federal
Register +++
http://www.pharmcast.com/FederalRegistrar/FRHome.htm
April 12, 2007
1. Notice: Availability of Funding Opportunity Announcement; Alzheimer's Disease Demonstration Grants to States (ADDGS) Program
April 11, 2007
1. Notice: Request for Applications for the Prevention of HIV/AIDS in Women Living in the Rural South Program
April 9, 2007
1. Notice: Draft Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products; Availability
2. Notice: Draft Guidance for Clinical Investigators, Sponsors, and Investigational Review Boards on Adverse Event Reporting--Improving Human Subject Protection; Availability
3. Notice: Draft Guidance for Industry on Orally Disintegrating Tablets; Availability
+++ PharmCast.com's Last Week Recent FDA
Links +++
http://www.pharmcast.com/FDALinks/FDALinksLatest.htm
April 13, 2007
1. FDA approves Altabax (retapamulin ointment) for topical treatment of impetigo, a skin infection caused by bacteria. FDA News (4/13/2007)
2. FDA will hold a public hearing on the medication guide program with the goal of improving risk communication. FDA News (4/13/2007)
3. 2007 Biological Approvals - Update (Posted: 4/13/2007)
April 12, 2007
1. Drugs@FDA Downloadable Data Files (updated 4/12/2007)
April 11, 2007
1. FDA updates a Patient Information Sheet for Colazal (balsalazide disodium) (4/11/2007)
2. Acorda Therapeutics and FDA inform healthcare professionals of changes to the product labeling for Zanaflex, a drug used to treat spasticity. MedWatch Safety Information (4/11/2007)
3. Inactive Ingredient Search (updated 4/11/2007)
April 10, 2007
1. Drug Safety Oversight Board Meeting, March 1, 2007, Public Summary (4/10/2007)
2. BPCA/Pediatric Exclusivity Statistics:
a. Breakdown of Requested Studies Report (updated
4/10/2007)
b. Pediatric Exclusivity Statistics (updated
4/10/2007)
c. Spectrum of Diseases/Conditions (updated
4/10/2007)
d. Written Requests Issued (updated 4/10/2007)
April 9, 2007
1. Prescription Drug User Fee Act (PDUFA) Therapeutic Biologic Billable Products (PDF, 4/9/2007)
2. Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients, June 12-13, 2007. Meeting Information (4/9/2007)
3. Fast Track Designation Request Performance Report - Update (Posted: 4/9/2007, Updated through: 3/31/2007)
4. Draft Guidance for Industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format (PDF - 96 KB) (4/9/2007)
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