--------- February 25 - 07 ---------

 

++++ PharmCast.com's Company Highlight +++++

Agilent Technologies Multi-Vendor Compliance Services -- Agilent offers a complete compliance program that includes qualification (IQ/OQ) for all common laboratory equipment, regardless of vendor.  This enables lab managers to make one call for any or all of their instrument compliance needs.

http://www.agilent.com/chem/0604pharm
 

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

1.  Safety Pharmacology in Drug Development, March 26-27, 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=073&source=pharmcast
 

2.  Pharmaceutical Sales & Marketing Executive Congress, March 26-27, 2007, Atlantic City, NJ.  Organized by iiBIG.

http://www.iibig.com/P0701
 

3.  Pharmaceutical & Biotech Patent Litigation Strategies 2007, March 27-28, 2007, London, UK.  Organized by IQPC.

http://www.iqpc.com/uk/ppl
 

4.  ManuPharma Summit, March 28-30, 2007, Monte-Carlo, Monaco.  Organized by Marcus Evans.

http://www.manupharmaeurope.com
 

5.  4th International Freedom to Operate Forum, March 29-30, 2007, London, UK.  Organized by C5.

http://www.c5-online.com/fto.htm
 

6.  microRNA in Human Disease and Development, March 29-30, 2007, Boston, MA.  Organized by Cambridge Healthtech Institute.

http://www.healthtech.com/2007/mrn/index.asp
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Feb2007/Home020607OG.htm


1.  Antibody to GALP and uses thereof

2.  Rescue agents for treating botulinum toxin intoxications

3.  Storage stable powder compositions of interleukin-4 receptor

4.  Scorpion toxins

5.  Nucleic acid formulations for gene delivery and methods of use

6.  Opioid agonist / antagonist combinations

7.  150 KDA TGF-B1 accessory receptor acts a negative modulator of TGF-B signaling

8.  Treatment of papillomavirus infections

9.  Methods and gel compositions for encapsulating living cells and organic molecules

10.  Use of ozone for the treatment of bad breath

11.  Mesoporous compositions for use in drug delivery

12.  Methods of detecting early renal disease in animals

13.  Methods to culture circovirus

14.  Biological compositions and methods for treatment of lung cancer

15.  Method for regulating neuron development and maintenance

16.  Virus vectors and methods of making and administering the same

17.  Combination particles for the treatment of asthma

18.  Method and preparations for stabilizing biological materials by drying methods without freezing

19.  Post-operative pain treatment by peripheral administration of a neurotoxin

20.  Controlled release insufflation carrier for medicaments

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

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

February 23, 2007

1.  Notice: Withdrawal of Approval of 128 Suitability Petitions

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

3.  Notice: Determination of Regulatory Review Period for Purposes of Patent Extension; AMITIZA

February 22, 2007

1.  Proposed Rule: Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use; Request for Information and Comments

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

3.  Proposed Rule: Schedules of Controlled Substances: Placement of Lisdexamfetamine into Schedule II

February 21, 2007

1.  Notice: Public Teleconference Regarding Licensing and Collaborative Research Opportunities for: PDE11A as a Novel Therapeutic Target for Inherited Form of Cushing Syndrome and Endocrine Tumors; Dr. Constantine A. Stratakis et al. (NICHD)

2.  Notice: Prospective Grant of Exclusive License: The Use of Adenovirus Vectors for the Development of Vaccines Against Human Immunodeficiency Virus and Other Infectious Agents

3.  Interim Final Rule: Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals

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

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

February 23, 2007

1.  Roche and FDA notify healthcare professionals that a clinical study on CellCept (mycophenolate mofetil) was terminated. MedWatch Information (2/23/2007)

2.  Rulemaking History for Nonprescription Products (updated 2/23/2007)

3.  CDER Key Officials (PDF, updated 2/23/2007)

4.  Biologic Product Withdrawal of Carimune NF Immune Globulin Intravenous - ZLB Behring (Posted: 2/22/2007; Recall Date: 2/21/2007)

February 22, 2007

1.  Manual of Policies and Procedures (MaPPs) (PDF, Updated 2/22/2007)
     a.  4601.2R Use of Alternative Workplaces for Commissioned Corps Officers
     b.  4634.3R Development, Maintenance, and Distribution of CDER Organizational Charts
     c.  5310.7 Acceptabilty of Alternative Compendia (BP/EP/JP)
     d.  7800.1R Administrative Management Coordinating Committee

February 21, 2007

1.  FDA directs ADHD drug manufacturers to notify patients about cardiovascular adverse events and psychiatric adverse events. ADHD Information. (2/21/2007)

2.  FDA issues an FDA Alert and Healthcare Professional Sheet for Xolair (omalizumab) Xolair Information (2/21/2007)

3.  ASBMT/CIBMTR BMT Tandem Meetings - Slide Presentation (Posted: 2/21/2007)
     a.  Regulatory Issues Session (PDF - 78 KB) - Ellen Lazarus, MD, FCAP

4.  Warning Letter - Wheaton Franciscan Healthcare (Posted: 2/21/2007, Issue Date: 1/24/2007)

5.  Drug Master Files (updated 2/21/2007)

February 20, 2007

1.  1st Annual FDA/DIA Statistics Forum (with FDA presenters), March 5-7, 2007, Doubletree Hotel & Executive Meeting Center, Bethesda, Maryland. Registration and Information (2/20/2007)

2.  Glaxo SmithKline notifies healthcare professionals to consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone. MedWatch Information (2/20/2007)

3.  Standardized Allergenic Extracts Licensed for Distribution in the United States (Posted: 2/20/2007)

4.  Well Characterized Biotechnology Pharmaceutical (WCBP) Symposium - Slide Presentation (Posted: 2/20/2007)
     a.  Common Challenges in Development of Cell and Gene Therapy Products (PDF - 263 KB) - Mike Havert, Ph.D.

_____________________________________________________________

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