FDA Grants Conditional Approval to Interventional Spine’s PercuDyn™ System IDE Application
Irvine, California, U.S.A 01 July 2008  Interventional Spine, Inc. announced that the U.S. Food and Drug Administration has approved the Company’s investigational device exemption (IDE) application for its PercuDyn System for the treatment of degenerative disc disease (DDD). This approval is conditional upon the Company providing some additional information to the FDA.
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Vaccine Containing Tumor Antigen Check Colon Cancer Spread in Mice
Philadelphia 26 June 2008  Scientists at the Kimmel Cancer Center, Jefferson Medical College have found a way to immunize mice against the development of metastatic disease, based on the fact that the intestines have a separate immune system from the rest of the body. Researchers were able to show that mice immunized with an intestinal protein developed fewer lung and liver metastases after injection with colon cancer cells than did control animals.
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Jefferson Scientists Find Blocking Signaling Protein Prevents Prostate Cancer Spread
Philadelphia 26 June 2008  Researchers at the Kimmel Cancer Center at Jefferson in Philadelphia have shown that by blocking a signaling protein, they can prevent prostate cancer cells from metastatic dissemination. The work opens the door to future studies examining the protein as a target for therapies aimed at keeping prostate cancer at bay.
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CLC bio releases Next Generation Sequencing data analysis solution
Aarhus, Denmark 12 June 2008  CLC bio revealed its new Next Generation Sequencing - NGS solution, CLC Genomics Workbench, which incorporates cutting-edge technology and algorithms, while also supporting and integrating with the rest of a typical NGS workflow.
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AstraZeneca Submits sNDA With U.S. FDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indicatio
Wilmington, Delaware, U.S.A 30 May 2008  AstraZeneca (NYSE: AZN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for NEXIUM(R) I.V.(esomeprazole sodium) for Injection to seek approval for use in patients with peptic ulcer bleeding (PUB) following therapeutic endoscopy. The regulatory submission incorporates data from the NEXIUM I.V. Peptic Ulcer Bleed study, a multinational, randomized trial of 767 patients with peptic ulcer bleeding (PUB).(1) To date, there is no proton pump inhibitor (PPI) therapy globally approved for this indication.(2) Presently, NEXIUM I.V. for Injection is indicated for the short-term treatment (up to 10 days) of GERD adult patients with a history of erosive esophagitis, as an alternative to oral therapy in patients when therapy with NEXIUM(R)(esomeprazole magnesium) Delayed-Release Capsules is not possible or appropriate.(3)
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