--------- March 11 - 07 ---------

 

+++ 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 5,600 people and serving a client base of over 250 global pharmaceutical and biotechnology companies.  Patheon offers development and manufacturing services in virtually all finished dosage forms with specialized expertise in liquid-filled hard capsules, high-potency, controlled-release and sterile manufacturing including aseptic filling and lyophilization.

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

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

1.  Skin Product Development, April 4-6, 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=070&source=pharmcast
 

2.  MedChem India, April 12-13, 2007, Hyderabad, India.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/medchemindia2007
 

3.  2nd Annual Hospital Operational Excellence Summit 2007, April 16-18, 2007, Chicago, IL.  Organized by IQPC.

http://www.iqpc.com/NA-11355-001
 

4.  2nd Annual Effective Coordination of Clinical Trials, April 17-18, 2007, Prague, Czech Republic.  Organized by Jacob Fleming Conferences.

http://www.jacobfleming.com/buxus/generate_page.php?page_id=358
 

5.  Biotech Patenting, April 18-19, 2007, Munich, Germany.  Organized by C5.

http://www.c5-online.com/biotech.htm
 

6.  5th Annual Pharm Branding Conference, April 24-25, 2007, Vienna, Austria.  Organized by Jacob Fleming Conferences.

http://www.jacobfleming.com/buxus/generate_page.php?page_id=361
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Feb2007/Home022007OG.htm


1.  Methods for treating a buttock deformity

2.  Differentiation of adipose stromal cells into osteoblasts and uses thereof

3.  Protein-stabilized liposomal formulations of pharmaceutical agents

4.  Nucleic acids encoding chimeric proteins comprising BMP-2 and a proteinase inhibitor

5.  Anti-hypertensive dietary supplement

6.  Use of prenylated flavones

7.  Antigenic, non-toxic mutants of Clostridium septicum alpha toxin and vaccines, antibodies, sera, and methods of treatment therewith

8.  Hollow capsule having a wall permeable to water or an aqueous solution

9.  Early leukemia diagnostics using microsphere arrays

10.  Gene responsible for stargardt-like dominant macular dystrophy

11.  Multivalent macrolide antibiotics

12.  Methods and compositions for the treatment of pain and other hormone-allergy-related symptoms using dilute hormone solutions

13.  Physiologically active complex

14.  Circovirus sequences associated with piglet weight loss disease (PWD)

15.  Composite antibodies of humanized human subgroup IV light chain capable of binding to TAG-72

16.  Beneficial effect of distiller's grain in cardiovascular disease

17.  Implant device with a retinoid for improved biocompatibility

18.  Treatment of alzheimer's disease

19.  Materials and methods for near-infrared and infrared lymph node mapping

20.  Device and a process for expansion of haemopoeitic stem cells for therapeutic use

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

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

March 9, 2007

1.  Notice: Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waiver/Reduction; Availability

2.  Notice: Review of Sourcing Change, Foreign-Trade Subzone 43D, Perrigo Company, Allegan, Michigan (Ibuprofen Products)

3.  Notice: Foreign-Trade Zone 38-Spartanburg County, South Carolina, Application for Subzone, Leiner Health Products LLC (Ibuprofen Products), Fort Mill, South Carolina

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

March 8, 2007

1.  Notice: Notice of Intent To Grant Partially Exclusive License

March 7, 2007

1.  Notice: Guidance on Drug Safety Information--Food and Drug Administration's Communication to the Public; Availability

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

March 6, 2007

1.  Notice: Guidance for Industry on Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children; Availability

2.  Final Rule: Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Amendment to the Monograph

March 5, 2007

1.  Notice: Determination That LAMICTAL (Lamotrigine) Tablets, 50 Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

2.  Final Rule: Advisory Committee: Change of Name and Function

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

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

March 9, 2007

1.  Takeda and FDA notify healthcare professionals to consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone products. MedWatch Safety Information (3/9/2007)

2.  CDER Data Standards Manual: Countries, Dependencies, and Areas of Special Sovereignty Monograph (updated 3/9/2007)

March 7, 2007

1.  Oligonucleotides Based Therapeutics Conference, Co-Sponsored by FDA, DIA, OTS, and Health Canada, April 19-20, 2007 Double Tree Hotel & Executive Meeting Center Bethesda, Maryland. Registration and Information (3/7/2007)

2.  2007 Biological Approvals - Update (Posted: 3/7/2007)

3.  Approved Biological NDA and ANDA Applications - Update (Posted: 3/7/2007, Updated through: 2/28/2007)

4.  Drug Approval Reports (3/7/2007)
     a.  CDER Drug and Biologic Approvals for Calendar Year 2007
     b.  CDER New Molecular Entity (NME) Drug and New Biologic Approvals in Calendar Year 2007
     c.  CDER Priority Drug and Biologic Approvals in Calendar Year 2007
     d.  NME Drug and New Biologic Approvals

March 6, 2007

1.  FDA Preliminary Public Health Notification: Unpredictable Events in Medical Equipment due to New Daylight Savings Time Change (Posted: 3/6/2007)
     a.  Advice for Patients: Change in Daylight Savings Time May Affect Your Medical Equipment in an Unpredictable Way - 3/1/2007

2.  FDA approves Tekturna (aliskiren) tablets, a new molectular entity, for the treatment of high blood pressure, or hypertension. FDA News (3/6/2007)

March 5, 2007

1.  Guidance for Industry: Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children [PDF] or [HTML] (3/5/2007)

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

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

1.  Sandoz, Inc. (Ergotamine Tartrate)

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