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FDA Approves Coartem Tablets To Treat Malaria
4/9/2009
The U.S. Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds).
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ACR Image Metrix Is Selected As Imaging CRO In Aegerion Pharmaceuticals Groundbreaking, Randomized Clinical Trial
4/7/2009
American College of Radiology (ACR) Image Metrix™ was chosen by Aegerion Pharmaceuticals for a groundbreaking, randomized clinical trial testing the efficacy and safety of an MTP inhibitor because of its unique capabilities in employing novel imaging technologies in drug development trials.
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U.S. FDA Approves OraQuick Advance 12-Month Shelf Life Dating
4/7/2009
OraSure Technologies, Inc. announced recently that the United States Food and Drug Administration (FDA) has approved its request for 12-month shelf life from the date of manufacture for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test.
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FDA Approves Generic Topamax To Prevent Seizures
4/6/2009
The U.S. Food and Drug Administration has approved the first generic versions of Topamax tablets (topiramate) to prevent seizures.
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Anderson Packaging Completes Refrigerated Storage Expansion
4/3/2009
Anderson Packaging announces the completion the expansion of its on-site refrigerated storage facility.
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Overlook Industries, Inc and Colanar, Inc Establish Strategic Alliance To Co-Promote Custom Single Use Fluid Path System
4/3/2009
Overlook Industries, Inc, designer and manufacturer of custom single use OneShot Filler Needles and Freedom Filler Kits and Colanar, Inc, designer and manufacturer of the FSP Peristaltic Pump, have established a strategic alliance to co-promote a single use fluid path system to satisfy low dosage fill requirements with extremely tight tolerances, as well as achieving rapid line changeover through the convenience of disposability.
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Afinitor® Approved In US As First Treatment For Patients With Advanced Kidney Cancer
3/31/2009
Novartis announced today that Afinitor® (everolimus) tablets has been approved by the US Food and Drug Administration (FDA) for patients with advanced renal cell carcinoma (RCC) after failure of treatment with Sutent® (sunitinib) or Nexavar® (sorafenib).
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FluGen Secures Exclusive Rights To Novel Vaccine-Delivery Technology
3/31/2009
FluGen Inc., an emerging leader in the development, production and delivery of influenza vaccines and related
products, today announced it has secured exclusive rights to a novel, patent-protected vaccine-delivery technology being commercialized by
Madison, Wis.-based Ratio Inc. Terms of the license agreement were not disclosed.
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Ranbaxy's Paonta Sahib Plant Receives MHRA, UK And TGA, Australia Approvals For GMP Compliance
3/25/2009
Ranbaxy Laboratories Limited (Ranbaxy) announced recently that the Medicines and Healthcare products Regulatory Agency (MHRA) of UK, and the Therapeutic Goods Administration (TGA), Department of Health and Ageing of the Australian Government, have issued Good Manufacturing Practice (GMP) certificates for its manufacturing site at Paonta Sahib (India), following a joint audit conducted in October 2008.
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SkyePharma Announces Filing Of New Drug Application For Flutiform To The FDA
3/24/2009
SkyePharma PLC recently announces the filing of a New Drug Application (“NDA”) for Flutiform (fluticasonepropionate/formoterol fumarate), SkyePharma’s lead development product for the maintenance treatment of asthma in patients 12 years of age and older, with the U.S. Food and Drug Administration.