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2011 FDA Biopharmaceutical Approvals: Low Number And Economic Impact, But A Record Number Of Orphan Approvals And Many Innovations
2/3/2012
The latest annual study of FDA biopharmaceutical product approvals by the Biotechnology Information Institute (BII) reports significant advances in health care, particularly approvals for new and orphan indications, but an overall low number of approvals and industry and economic impact.
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Bayer Initiates Expanded Access Program For Investigational Compound Radium-223 Chloride
2/3/2012
Bayer HealthCare, LLC today announced that the U.S. Food and Drug Administration agreed that Bayer can proceed with its expanded access program to provide the investigational drug radium-223 chloride to patients diagnosed with castration-resistant prostate cancer (CRPC)/hormone-refractory prostate cancer (HRPC) with symptomatic bone metastases.
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Synthetic Genomics, Inc. And Integrated DNA Technologies, Inc. Sign Agreement To Manufacture, Market, And Commercialize Small Synthetic Gene Products Using SGI Technology
2/3/2012
Synthetic Genomics, Inc. (SGI), a privately held company commercializing and developing genomic-driven solutions to solve a variety of global needs, and Integrated DNA Technologies, Inc. (IDT), the world leader in production and supply of oligonucleotides, today jointly announced that they have entered into an agreement to manufacture, market, and commercialize small synthetic gene products.
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Del Mar Pharmaceuticals Granted U.S. Orphan Drug Designation For VAL-083 For The Treatment Of Glioma
2/3/2012
DelMar Pharma today announced that the United States FDA Office of Orphan Products Development has granted orphan drug designation for VAL-083 for the treatment of glioma, including glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.
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ILC Dover’s Sentinel XT™ PAPR Receives NIOSH Approval
2/2/2012
ILC Dover, the manufacturer of Innovative Protective Equipment for the most demanding applications including spacesuits for NASA, announced recently that the National Institute for Occupational Safety and Health has approved its Sentinel XT as a Loose Fitting Powered Air Purifying Respirator (PAPR) (TC-21C-0901).
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'Pulverized' Chromosomes Linked To Cancer?
2/1/2012
They are the Robinson Crusoes of the intracellular world – lone chromosomes, whole and hardy, stranded outside the nucleus where their fellow chromosomes reside. By David Pellman, MD
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FDA Approves BYDUREON™ – The First And Only Once-Weekly Treatment For Type 2 Diabetes
2/1/2012
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved BYDUREON™ (exenatide extended-release for injectable suspension) – the first once-weekly treatment for type 2 diabetes.
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UF Researchers Develop Gene Therapy That Could Correct A Common Form Of Blindness
2/1/2012
A new gene therapy method developed by University of Florida researchers has the potential to treat a common form of blindness that strikes both youngsters and adults.
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Private And Public Partners Unite To Combat 10 Neglected Tropical Diseases By 2020
2/1/2012
Recently, 13 pharmaceutical companies, the U.S., U.K. and U.A.E governments, the Bill & Melinda Gates Foundation, the World Bank and other global health organisations announced a new, coordinated push to accelerate progress toward eliminating or controlling 10 neglected tropical diseases (NTDs) by the end of the decade.
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Integrated DNA Technologies Introduces gBlocks Gene Fragments
2/1/2012
Integrated DNA Technologies (IDT), the world leader in oligonucleotide synthesis, announced recently that it is taking orders for a new product that represents a significant advancement for synthetic biology tools.