--------- February 10 - 08 ---------

 

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

Patheon provides integrated dosage form development and contract manufacturing services from a network of 14 facilities in Europe and North America, employing more than 5,000 people and serving a client base of more than 250 global pharmaceutical and biotechnology companies.  Patheon offers development, manufacturing and packaging services in virtually all finished dosage forms with specialized expertise in liquid-filled hard capsules, high-potency, controlled-release, disposable technologies, biopharmaceuticals and sterile manufacturing including aseptic filling and lyophilization.

http://www.pharmcast.com/BuyersGuide/Patheon/PatheonComInfo.htm

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

1.  FDA Inspections of Clinical Data Systems, March 19-20, 2008, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=034&source=pharmcast
 

2.  Residual Solvents: Results in Practice Seminar (1 day) (Classroom/ Online).  Organized by USP (United States Pharmacopeia).

http://www.usp.org/goto/phcnav1
 

3.  Web Seminar: A GMP Approach to the Detection, Correction and Prevention of Human Errors, February 28, 2008.  Speaker: Johnny Guerra, ex-FDA.  Organized by BenAstrum, Inc. (Use promotional code PC0208 for 10% discount)

http://www.benastrum.com/index.php?option=com_content&task=view&id=39&Itemid=69
 

4.  Pharmaceutical Industry in Thailand, March 31 - April 1, 2008, Bangkok, Thailand.  Sponsored by Asia Business Forum (Thailand).

http://www.abf-asia.com/project/868-PharmCast.pdf
 

5.  Pharmaceutical Patent Litigation Strategies 2008, March 31 - April 1, 2008, London, UK.  Organized by IQPC.

http://www.iqpc.com/uk/patlit/diary
 

6.  2nd Annual Pharmaceutical Sales & Marketing Executive Congress, March 31 – April 1, 2008, Bethesda, MD.  Organized by iiBIG.

http://www.iibig.com/P0802
 

7.  Chiral Processes: Master Separation: Crystallisation - Purification - Scale-Up - Patenting, March 31 - April 2, 2008, Berlin, Germany.  Organized by IQPC.

http://www.iqpc.com/de/chiral
 

8.  Laboratory Informatics, March 31 - April 3, 2008, San Francisco, CA.  Organized by IQPC.

http://www.iqpc.com/us/lab
 

9.  C5’s Managing Multi-Jurisdictional Legal and Regulatory Risks in Clinical Trials, April 15 - 16, 2008, Brussels, Belgium.  Organized by C5.

http://www.C5-Online.com/clinical
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2008/Jan2008/Home012208OG.htm
 

1.  Protease assay for therapeutic drug monitoring

2.  Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology

3.  Dietary and pharmaceutical compositions containing lyophilized lactic bacteria, their preparation and use

4.  Framework-patched immunoglobulins

5.  Compositions and methods for treating NIDDM and other conditions and disorders associated with AMPK regulation

6.  Methods and compositions for delivery of pharmaceutical agents

7.  Discrimination method of target base in DNA, and allele specific primer used in the method of the same

8.  Ependymal neural stem cells and method for their isolation

9.  Methods of treatment using nanoparticulate fenofibrate compositions

10.  Crystalline choline ascorbate

11.  Cough depressant composition containing iron for angiotensin-converting enzyme inhibitor inducing cough

12.  Molecular antigen array

13.  Identifying drugs for and diagnosis of benign prostatic hyperplasia using gene expression profiles

14.  Soluble steroidal peptides for nucleic acid delivery

15.  Enzyme treatment of foodstuffs for Celiac Sprue

16.  Rodent hepatitis B virus core proteins as vaccine platforms and methods of use thereof

17.  Transporter protein

18.  Photodynamic therapy treatment for eye disease

19.  Characterization of the earliest stages of the severe acute respiratory syndrome (SARS) virus and uses thereof

20.  Vaginally administrable progesterone-containing tablets and method for preparing same

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

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

February 8, 2008

1.  Notice: Drug Products Containing Colchicine for Injection; Enforcement Action Dates

2.  Direct Final Rule: Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment

3.  Proposed Rule: Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System

February 6, 2008

1.  Notice: Memorandum of Understanding Between the Food and Drug Administration and the National Institutes of Health

February 5, 2008

1.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank

2.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking

3.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Listing Information for Medical Device Registration and Listing

4.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program

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

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

February 8, 2008

1.  FDA issues an Early Communication about an Ongoing Safety Review for Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) (2/8/2008)

2. Fourth Annual FDA and the Changing Paradigm for HCT/P Regulation, San Antonio, Texas - 1/8-11/2008 (Posted 2/8/2008)
    a. HCT/P Compliance Update (PDF 93 KB) - Mary Malarkey, OCBQ, CBER
    b. Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Melissa Greenwald, MD

3.  Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) - Updated Posted: 2/8/2008; Meeting Date: 4/29-30/2008 (Posted 2/8/2008)

4.  FEDERAL REGISTER: Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment; Direct Final Rule (2/8/2008)

February 7, 2008

1.  On February 6, FDA approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis (2/7/2008)

2.  Adverse Event Reporting System (AERS) Latest Quarterly Data Files (2/7/2008)

3.  Drug to be Discontinued: Humatin (Paromomycin Sulfate Capsules, USP) (2/7/2008)

4.  Clinical Hold/Refusal to File Meetings - 2008 Schedule (Posted: 2/7/2008)

5.  Approved Biological NDA and ANDA Applications - Update (Posted: 2/7/2008, Updated through: 1/31/2008)

6.  Cleared Biological 510(k) Device Applications - Update (Posted: 2/7/2008, Updated through: 1/31/2008)

7.  Approved Biological Premarket Approval (PMA) Device Applications - Update (Posted: 2/7/2008, Updated through: 1/31/2008)

8.  Licensed Products and Establishments List - Update (Posted: 2/7/2008, Updated through: 1/31/2008)

February 6, 2008

1.  FDA takes action to stop the marketing of unapproved injectable drugs containing colchicine (2/6/2008)

2.  CDER Organization Charts [HTML] [PDF] (updated 2/6/2008)

3.  Drugs@FDA Downloadable Data Files (updated 2/6/2008)

February 5, 2008

1.  Division of Scientific Investigations, Office of Compliance: Contact DSI (updated 2/5/2008)

2.  Drug Shortage: Resolved; Tikosyn (0.5mg and 0.25mg capsules) (2/5/2008)

February 4, 2008

1.  Standard Costs for Components of the Process for the Review of Human Drug Applications [HTML] [PDF] (2/4/2008)

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