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EnteroMedics Announces Reduction in Workforce 1 Dec 2008 22:33 GMT
... the EMPOWER pivotal clinical trial for US approval of VBLOC Therapy for the treatment of ... has met its enrollment goal under an FDA-approved Investigational Device Exemption (IDE) for the EMPOWER ...
Cytokinetics Announces Clinical Trial Data Regarding SB-743921 to Be Presented at the 2008 American Society of Hematology Annual Meeting and Exposition 1 Dec 2008 22:32 GMT
... ) announced today that an abstract summarizing interim clinical ... or delays in the development, testing, regulatory approval, production and marketing of Cytokinetics' drug candidates ... effects or inadequate therapeutic efficacy, the U.S. Food and Drug Administration or foreign regulatory agencies may ...
Drugmakers' trade group spent $5.4M lobbying in 3Q 1 Dec 2008 22:32 GMT
... prescription drugs, and the budgets for the Food and Drug Administration and the Department of Health ... on a bill designed to give the FDA authority to approve generic versions of biotech drugs. Unlike traditional ...
UPDATE 2-Data supports Novartis malaria drug -US... 1 Dec 2008 22:31 GMT
... UPDATE 2-Data supports Novartis malaria drug -US FDA staff UPDATE 2-Data supports Novartis malaria drug ... and causes few serious side effects, U.S. Food and Drug Administration regulatory staff said in documents released on ... where the mosquito-borne disease is prevalent. If approved, Coartem would be the first artemisinin-based combination ...
Cell Therapeutics gets fast-track evaluation of drug 1 Dec 2008 22:19 GMT
... of drug Cell Therapeutics' request to expand approved uses for cancer drug Zevalin will get ... fast-track review from federal regulators. The U.S. Food and Drug Administration granted priority review to Zevalin, which the ... non-Hodgkin's lymphoma, a much smaller group. The FDA said it would aim to make a ...

Allos cancer drug gets another orphan designation from FDA, protecting it from competition 1 Dec 2008 22:19 GMT
... cancer drug gets another orphan designation from FDA, protecting it from competition Allos cancer drug ... pralatrexate that protects it from competition if approved. The biotechnology company said the Food and Drug Administration granted the candidate orphaned drug status for ...
InSite Vision Announces Corporate Restructuring To Focus on Growth Opportunities and Conserve Resources 1 Dec 2008 22:16 GMT
... disease in adults. There is no existing FDA-approved drug indicated to treat this condition. InSite ... ability of InSite’s international partners to obtain approval to market AzaSite outside the U.S. and ...
MoneyTV, Week of 11/28 1 Dec 2008 22:15 GMT
... of $200 million in transaction processing in 2009. ) CEO Dean Janes discussed the FDA approval process for the company's medical imaging product. ) CEO Riggs Eckelberry envisioned a future ...
UPDATE 2-Data supports Novartis malaria drug -US FDA staff 1 Dec 2008 21:54 GMT
... and causes few serious side effects, U.S. Food and Drug Administration regulatory staff said in documents released on ... wrote in documents released ahead of an FDA advisory panel meeting on Wednesday to discuss ... to treat acute, uncomplicated malaria infections. If approved, Coartem would be the first artemisinin-based combination ...
QAI Helps Local Counties Emerge From Paper Piles 1 Dec 2008 21:54 GMT
... for companies trying to get pesticide products approved by the Environmental Protection Agency. "This is ... certain hard-copy documents. "A lot of the approval processes once involved paper," he said. "Today ... [National Institutes of Health], and also the FDA [Food and Drug Administration] and Centers for Disease Control." In a ...
Drugmakers' trade group spent over $5.4 million lobbying government in third quarter 1 Dec 2008 21:54 GMT
... PhRMA also lobbied on a bill designed to give the FDA authority to approve generic versions of biotech drugs. Unlike traditional chemical drugs, biotech drugs have never faced generic ...
White Paper Addresses FDA Approval Challenges Facing Combination Product Manufacturers 1 Dec 2008 21:54 GMT
... White Paper Addresses FDA Approval Challenges Facing Combination Product Manufacturers AGAWAM, Mass., ... as well as pass muster with the Food and Drug Administration (FDA), the International Organization for ...
China Medicine Corporation Awarded GSP Certification 1 Dec 2008 21:54 GMT
... for Pharmaceutical Products) certification from the Guangdong Food and Drug Administration (Guangdong FDA). The GSP certification is given to pharmaceutical ... The Company expects to receive the official approval in approximately 7 days for the aforementioned ...
U.S FDA Grants Pralatrexate Orphan Drug Designation for the Treatment of Patients with Follicular Lymphoma 1 Dec 2008 21:53 GMT
... U.S FDA Grants Pralatrexate Orphan Drug Designation for the ... of cancer, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to the ... period once a designated orphan drug is approved for marketing. In addition to potential market ...
Digital Angel Announces Agreement with Lender to Reduce Current Principal Repayments 1 Dec 2008 21:53 GMT
... are utilized around the world in such applications as pet identification using its patented, FDA-approved implantable microchip; livestock identification and tracking using visual and radio frequency identification (RFID) ear ...

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