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Chiron Corporation - Physicians - History & Milestones
For more than 20 years, Chiron has been an industry leader, making groundbreaking scientific discoveries and creating revolutionary products that are improving human health worldwide.
BETASERON ® INTERFERON BETA-1b gains expanded U.S.
PROCLEIX ® System , a state-of-the-art blood-screening product, launched in the United States.
TOBI ® tobramycin solution for...
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Chiron Corporation - Research - History
- - For more than 20 years, Chiron has been an industry leader, making groundbreaking scientific discoveries and creating revolutionary products that are improving human health worldwide.
Food and Drug Administration (FDA) labeling approval for treating relapsing forms of multiple sclerosis.
Matrix Pharmaceutical Inc.
TOBI ® tobramycin solution for inhalation, the first...
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Chiron Media Kit page 2
author: Chiron Corporation
subject: For your convenience, printable versions of key information from various sections of our corporate site can be found here in PDF format. To the best of Chiron s knowledge, all information included is timely and accurate as of the date originally issued.
duplicates:
http://www.chiron.com/media/mediakit/media_chiron_history.pdf
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Chiron Media Kit
Howard Pien Chief Executive Officer and Chairman of the Board, Chiron Corporation Raymund Breu, Ph.
acquired.
REGRANEX® GEL (becaplermin), a breakthrough topical treatment for diabetic foot ulcers, introduced in partnership with Johnson & Johnson.
Hepatitis B antigens discovered and cloned; technology used to develop the first genetically engineered vaccine....
author: Chiron Corporation
subject: For your convenience, printable versions of key information from various sections of our corporate site can be found here in PDF format. To the best of Chiron s knowledge, all information included is timely and accurate as of the date originally issued.
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Chiron History
For more than 20 years, Chiron has been an industry leader, making groundbreaking scientific discoveries and creating revolutionary products that are improving human health worldwide.
K.- based vaccines company, acquired.
Food and Drug Administration (FDA) labeling approval for treating relapsing forms of multiple sclerosis.
MENJUGATE ® , a groundbreaking conjugate...
author: Chiron Corporation
subject: For your convenience, printable versions of key information from various sections of our corporate site can be found here in PDF format. To the best of Chiron s knowledge, all information included is timely and accurate as of the date originally issued.
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Chiron Corporation - Media - Chiron History
For more than 20 years, Chiron has been an industry leader, making groundbreaking scientific discoveries and creating revolutionary products that are improving human health worldwide.
PROCLEIX ® System , a state-of-the-art blood-screening product, launched in the United States.
MENJUGATE ® , a groundbreaking conjugate vaccine against meningococcal C disease, approved in...
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Chiron Corporation - About Us - History
- - For more than 20 years, Chiron has been an industry leader, making groundbreaking scientific discoveries and creating revolutionary products that are improving human health worldwide.
BETASERON ® INTERFERON BETA-1b gains expanded U.S.
PROCLEIX ® System , a state-of-the-art blood-screening product, launched in the United States.
TOBI ® tobramycin solution for...
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Chiron Corporation - Products - BioPharmaceuticals - Regranex Gel
- - REGRANEX® GEL (becaplermin) is a prescription drug approved by the U.S.
Chiron, under contract with Johnson & Johnson, manufactures becaplermin, a genetically engineered platelet-derived growth factor that is the active pharmaceutical ingredient in REGRANEX®.
- - www.regranex.com (800) CHIRON-8 (800-244-7668) - Trademarks -|- Disclaimer -|-...
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Therapeutic Biological Approvals
14 Cambridge Center Cambridge, MA 02142 License 1204 05/17/1996 Avonex Interferon beta-1a Revised Package Insert: To include safety and efficacy data from a study of patients who experienced a single clinical exacerbation of multiple sclerosis and to provide a Medication Guide 103628 / 5001 Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204 1/31/2003 Avonex Interferon...
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Dermatologic and Ophthalmic Advisory Committee Meetings
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Dermatologic and Ophthalmic Advisory Committee Meetings List of Tentative Meeting Dates for All CDER Advisory Committees List of Committee Members Committee Charter CDER Contacts Current Year Meeting Information 2004 FDA Advisory Committee Calendar -Meeting information includes center, date,...
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Janssen Pharmaceutica
|- Nederlands -| -English-| nextAd() NS4 = (document.layers)
In 1979, our parent company, Johnson & Johnson, in association with McDonnell Douglas and NASA, attempted to manufacture proteins, including erythropoietin, on board the space shuttle
In 1984, Johnson & Johnson joined forces with Amgen, a small biotechnology company still in its start-up phase, which had developed a...
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Ortho-McNeil: News Center
- - - Podiatry Group Honors ORTHO-McNEIL PHARMACEUTICAL —The Fund for Podiatric Medical Education Recognizes Ortho-McNeil for its Educational Commitment — PHILADELPHIA, PA, August 10, 2000 —The Fund for Podiatric Medical Education (FPME) today awarded Ortho-McNeil Pharmaceutical, Inc., marketer of REGRANEX® (becaplermin) Gel 0.01%, its ninth annual...
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Approved Biotechnology Drugs, 2002
Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
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Becaplermin - Product Approval Information - Licensing Action
Becaplermin is indicated for treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond, and have adequate blood supply
Under this authorization, you are approved to manufacture Becaplermin utilizing Becaplermin Concentrate manufactured by Chiron Corporation (Biologics License No
In addition; we acknowledge your...
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Becaplermin - Product Approval Information - Licensing Action
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Becaplermin Product Approval Information - Licensing Action Proper name: Becaplermin Tradename: Regranex Manufacturer: OMJ Pharmaceuticals, Inc, Manati, Puerto Rico, License #1196 Indication for Use: Treatment of lower extremity diabetic neuropathic ulcers that extend into...
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drugname - Product Approval Information - Licensing Action
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Talk Papers Therapeutic Biological Products FDA Approves First Treatment for Genetic Metabolic Disorder Including Hurler Disorder - 4/30/2003 FDA Approves First Treatment for Fabry Disease - 4/24/2003 FDA Statement on Counterfeit Procrit - 3/11/2003 FDA Approves First Biologic Therapy for...
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http://www.easy.no/affitech/pdf/das1.pdf page 1
duplicates:
http://www.iscpubs.com/articles/abl/b0002das.pdf
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Prescription Drug User Fee Act - User Fee Billable Therapeutic Products: Approved Under Section 351 of the PHS Act
u/vial MedImmune, Inc License 1252 Synagis Palivizumab 103770/0 6/19/1998 50 mg/vial 100 mg/vial Merck & Co., Inc License 0002 Elspar Asparaginase 101063/0 1/10/1978 10,000 IU/vial Novartis Pharmaceuticals Corp License 1244 Simulect Basiliximab 103764/0 5/12/1998 10 mg/vial 20 mg/vial OMJ Pharmaceuticals, Inc License 1196 Regranex Becaplermin 103691/0 12/16/1997 100 mcg...
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http://www.fda.gov/cder/biologics/review/becaomj121697-r3.pdf
D., Chief PLA 96- 1408 REGRANEX@ (becaplermin) Gel (recombinant human platelet- derived growth factor) in the treatment of diabetic ulcers, The R
Subjects were randomly assigned to be treated once daily with either becaplermin 100 ug/ g (124 subjects), becaplermin 30 ug/ g (132 subjects), or visually identical vehicle (127 subjects)
In contrast, the...
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http://www.fda.gov/cder/biologics/review/becaomj121697-r3.pdf page 8
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http://www.fda.gov/cder/biologics/review/becaomj121697-r3.pdf page 7
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http://www.fda.gov/cder/biologics/review/becaomj121697-r3.pdf page 1
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http://www.fda.gov/cder/biologics/review/becaomj121697-r4.pdf
Re: Review of Biologics License Application #96- l 408 Sponsor: OMJ Pharmaceuticals Scientific Name: Platelet- Derived Growth Factor- BB USAN or Proper Name of Drug Substance: Becaplermin Final Drug Product Name: Regranex Indication: Diabetic Foot Ulcers OMJ BLA #96- 1408 Volume 3 Chapter 4: Chemistry, Manufacturing and Controls I
Druo Substance The drug substance, ...
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http://www.fda.gov/cder/biologics/review/becaomj121697-r4.pdf page 7
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http://www.fda.gov/cder/biologics/review/becaomj121697-r4.pdf page 1
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