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FDA Calendar Updates: Biomoda, Dynavax
DVAX
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-30.05%
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98 days
Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of 286 entries as of 8/4/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial result...
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Dynavax Technologies Corp.
DVAX
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-7.25%
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136 days
Last trade signal was SELL at 2008-Dec-22 Price: $0.97 Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic in...
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Bullish on DVAX ...
DVAX
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-30.72%
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160 days
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of Toll-like Receptor (TLR) product candidates primarily in the United States. Based on Dynavax?s proprietary technology platform, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. The company?s product programs are supported by global partnerships with pharmaceutical companies, such as GlaxoSmithKline, AstraZeneca AB, and Novartis Vaccines and Diagnostics, Inc, as well as funding from Symph...
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From the Blogosphere
Dynavax with new HEPLISAV Data (NASDAQ:DVAX)
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In one of the most surprising news today, Dynavax Technologies Corporation (NASDAQ:DVAX) has announced that the first clinical data of their HEPLISAV has shown increase in the protection rate for chronic kidney disease patients. The data ...
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Unusual 11 Mid-Day Movers 10/22: UAUA, CHRW, EEV, CRI Higher; DVAX, CVH, KND, SNDK Lower
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Dynavax (NASDAQ: DVAX) 78.1% LOWER; The FDA has advised Dynavax and Merck that the balance of risk versus potential benefit no longer favors continued clinical evaluation of HEPLISAV in healthy adults and children. The FDA has also advised the companies that there may be potential for an acceptable risk versus benefit profile for HEPLISAV in patients with renal failure, and requested additional information from the companies before considering further pursuit of clinical studies in those patients. Dynavax and Merck are evaluating the FDA's response in considering next steps. In the meantime...
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Morning Movers 10/22: Coventry Health (CVH) Sinks On Results, SanDisk (SNDK) Down After Offer Pulled; Apple (AAPL) Higher On EPS
<>StreetInsider.com Morning Movers:
ICO Global Communications Limited (NASDAQ: ICOG) 100% HIGHER; was awarded at least $371 million in its litigation with The Boeing Company (NYSE: BA) and Boeing Satellite Systems International.
Dynavax (NASDAQ: DVAX) 40% LOWER; The FDA has advised Dynavax and Merck that the balance of risk versus potential benefit no longer favors continued clinical evaluation of HEPLISAV in healthy adults and children. The FDA has also advised the companies that there may be potential for an acceptable risk versus benefit profile for HEPLISAV in patients with renal failure,>...
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Shares of Dynavax Technologies Corporation (NASDAQ: DVAX) Climb on Successful Phase 3 Trial and Second Quarter Financial Results
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Dynavax Technologies Corporation (NASDAQ: DVAX), a developer of innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergy, cancer and chronic inflammatory diseases by utilizing versatile, proprietary approaches to alter immune system responses, recently announced the results form a Phase 3 clinical trial and the company’s second quarter financial results. <>Shares of Dynavax Technologies climbed higher earlier this week after the company announced positive top line results from a Phase 3 clinical trial comparing HEPLISAV™, an investigation><>><>><>>< /><>><>><>><>>< /><><>< />><>< />><>< />>>< />...
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Clinical Hold on Dynavax Drug
DVAX
-14.09%
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487 days
We are intrigued by DynavaxÂ?s proprietary ImmunoStimulatory Sequence technology, but disappointed with the clinical hold on its lead candidate Heplisav. This part was added on experimental basis to see the effect. This part was added on experimental basis to see the effect. This part was added on experimental basis to see the effect. This part was added on experimental basis to see the effect. This part was added on experimental basis to see the effect. This part was added on experimental basis to see the effect. This part was added on experimental basis to see the effect. This part was a...
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