--------- February 4 - 07 ---------

 

+++ PharmCast.com's Healthcare MBA Program Highlight+++

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

1.  Good Laboratory Practice for Pre-Clinical Testing, Compliance, QA & Audit, March 5-6 , 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=040&source=pharmcast
 

2.  Advances in Microarray Technology, May 15-16, 2007, Edinburgh, UK.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/AMT2007
 

3.  Lab-on-a-Chip World Congress (Life Science Applications), May 15-16, 2007, Edinburgh, UK.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/loac2007
 

3.  SEQNSYNTECH (Advances in Nucleic Acid Sequencing & Synthesis), May 15-16, 2007, Edinburgh, UK.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/SEQNSYNTECH2007
 

4.  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/
 

5.  2007 BioPharmaceutical Outsourcing R&D Leadership Summit: "Leveraging CRO-BioPharma Partnerships to Feed the Pipeline Beast", May 21-22, 2007, Atlantic City, NJ.  Organized by iiBIG.

http://www.iibig.com/P0702
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Jan2007/Home011607OG.htm


1.  Intravenous valproate for acute treatment of migraine headache

2.  Microencapsulation and sustained release of biologically active polypeptides

3.  Compositions and methods for the treatment of immune related diseases

4.  RANTES mutants and therapeutic applications thereof

5.  Treatment and diagnosis of cancer

6.  Adjuvant-containing vaccines

7.  Random truncation and amplification of nucleic acid

8.  Reovirus for the treatment of ral-mediated cellular proliferative disorders

9.  Amorphous drug beads

10.  Gene targeting using replicating DNA molecules

11.  Clot-specific streptokinase proteins possessing altered plasminogen activation characteristics and a process for their preparation

12.  Peptide with osteogenic activity

13.  Long-term stabilized formulations

14.  Injection made from Ixeris Sonchifolia Hance for treatment of cardio-cerebral vascular diseases and fundus diseases and method of producing thereof

15.  Controlled drug delivery system using the conjugation of drug to biodegradable polyester

16.  Compositions and methods for the treatment of primary and metastatic neoplastic diseases using arsenic compounds

17.  Progestin co-micronized with a surfactant pharmaceutical composition comprising same methods for making same and uses thereof

18.  Method of increasing bone toughness and stiffness and reducing fractures

19.  Controlled release microencapsulated NGF formulation

20.  Escherichia coli strain for an oral vaccine against post-weaning diarrhea in pigs

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

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

February 2, 2007

1.  Notice: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability

2.  Notice: Determination That SUSTIVA (Efavirenz) 300-Milligram Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

3.  Notice: Agency Emergency Processing Under Office of Management and Budget Review; Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Labeling Comprehension Study

4.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 456h and 2567

5.  Final Rule: National Science Foundation Implementation of OMB Guidance on Nonprocurement Debarment and Suspension

February 1, 2007

1.  Notice: Regulatory Site Visit Training Program

2.  Notice: University of Arkansas/Food and Drug Administration Food Labeling Workshop; Public Workshop

3.  Final Rule: Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container

January 31, 2007

1.  Proposed Rule: Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live Vaccines

2.  Proposed Rule: Viruses, Serums, Toxins, and Analogous Products; Detection of Avian Lymphoid Leukosis Virus

3.  Finale Rule: Conditional Release Period and CBP Bond Obligations for Food, Drugs, Devices, and Cosmetics

January 30, 2007

1.  Notice: Indevus Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application

2.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A

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

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

5.  Notice: Prospective Grant of Exclusive License: Use of Inhaled Nitrite Therapy for the Treatment of Pulmonary Conditions

6.  Notice: Prospective Grant of Co-Exclusive License: Prevention and Treatment of Human Cancer and Tumors by Inhibitors of Any or All of the Adenosine Receptor Subtypes Covered by the Licensed Patent Rights

January 29, 2007

1.  Notice: Hospira, Inc., and Mayne Pharma Limited; Analysis of Proposed Consent Order To Aid Public Comment

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

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

February 2, 2007

1.  Approved Biological NDA and ANDA Applications - Update (Posted: 2/2/2007, Updated through: 1/31/2007)

2.  Cleared Biological 510(k) Device Applications - Update (Posted: 2/2/2007, Updated through: 1/31/2007)

3.  Approved Biological Premarket Approval (PMA) Device Applications - Update (Posted: 2/2/2007, Updated through: 1/31/2007)

4.  New or Updated Patient Information sheets for:
    a.  Avastin (bevacizumab)(2/2/2007)
    b.  NovoLog (insulin aspart recombinant) (2/2/2007)
    c.  Velcade (bortezomib)(2/2/2007)

February 1, 2007

1.  Division of Drug Marketing, Advertising, and Communications (DDMAC) (updated 2/1/2006)

2.  Inactive Ingredient Download File (updated 2/1/2006)

3.  Inactive Ingredient Database Search (updated 2/1/2006)

4.  Clinical Hold / Refusal to File - 2007 Meeting Schedule (Posted: 2/1/2007)

5.  Guidance for Industry: Comprehensive List of Guidance Documents (PDF, updated 2/1/2007)

6.  Guidance for Industry: New/Revised/Withdrawn List for 2007 (PDF, updated 2/1/2007)

January 31, 2007

1.  Postmarketing Study Commitments (1/31/2007)

2.  Devices Regulated by CBER - Updated (Posted: 1/31/2007)

3.  Medication Guides for Wellbutrin (PDF) and Wellbutrin SR (PDF) (2006 versions) (1/31/2007)

4.  Drug Approval Reports (Updated 1/31/2007)
     a.  Accelerated and Restricted Approvals Under Subpart H (drugs) and Subpart E (biologics) NDAs, NDA Supplements, BLAs, and BLA Supplements
     b.  Active INDs
     c.  IND Receipts
     d.  Efficacy Supplement Approvals
     e.  NDA and BLA Approvals
     f.  NME Drug and New Biologic Approvals
     g.  Number of NDA Receipts by Calendar Year
     h.  Priority NDA and BLA Approvals

January 30, 2007

1.  FDA outlines a comprehensive commitment to the safety of drugs and other medical products. FDA News and FDA's "The Future of Drug Safety" report (1/30/2007)

2.  FDA MedWatch and Patient Safety Online Tutorial (1/30/2007)

3.  Donor Screening Tests for Testing HCT/P Donors - Updated (Posted: 1/30/2007)

4.  New or Updated Patient Information sheets for:
    a.  Noxafil (posaconazole)(1/30/2007)
    b.  Tyzeka (telbivudine)(1/30/2007)

January 29, 2007

1.  Office of Generic Drugs: Model Bioequivalence Data Summary Tables (1/29/2007)

2.  Collaborative Scientific Training Program (Posted: 1/29/2007)

3.  Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis - Update (Posted: 1/29/2007, Updated as of: 1/28/2007)

4.  CDER Organization Charts [HTML] [PDF] (updated 1/28/2007)

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

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

1.  MGI Pharma, Inc. (Gliadel® Wafer (polifeprosan 20 with carmustine implant))

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