FDA Calendar Updates: AZN, GSK, SNY Print E-mail
Monday, 04 May 2009 18:07
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
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The Bionic Arms Race Produces Extremely Tangible Results Print E-mail
By M.E.Garza   
Saturday, 02 May 2009 10:02
To say loss of an arm changes your life is an understatement. Tasks you once took for granted now pose a significant challenge. Prosthetic devices help, but they can be quite difficult to control, requiring unnatural movements of small chest muscles. During a presentation during Veterans Affairs Research Week, scientists demonstrated a new bionic arm that can do everything from picking up a grape without smooshing it to tossing a ball to reaching for an item on a high shelf.It can even be used to operate power tools.
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Video: Symptoms of the Swine Flu from the CDC Print E-mail
By Lauran Neergaard   
Friday, 01 May 2009 23:55
CDC influenza expert, Joseph Bresee, M.D., describes how to recognize the signs and symptoms of swine flu including how swine flu is transmitted, appropriate medicines for treatment and steps to take to prevent or treat illness.The World Health Organization says it will stop using the term "swine flu" to avoid confusion over the danger posed by pigs. It will instead refer to the virus by its scientific name, "H1N1 influenza A."
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FDA Calendar Updates: Botox Rival Approved Print E-mail
Friday, 01 May 2009 11:06
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
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FDA Calendar Updates: AMAG Pharma Up, Northfield Labs Down Print E-mail
Thursday, 30 April 2009 19:34
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted. AMAG Pharma (NASDAQ:AMAG) reported its quarterly results after the market close on Thursday, but the stock was trading higher after-hours by about 20% on news that the FDA was satisfied with observations noted during a recent inspection of the Company's manufacturing facility.
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Sequenom Splattered, EXACT Sciences on the Rise Print E-mail
Thursday, 30 April 2009 08:44
With Sequenom (NASDAQ:SQNM) losing about three-quarters of its market value in pre-market trading to around 3 bucks per share; EXACT Sciences (NASDAQ:EXAS) is poised to continue its comeback from penny stock levels late last year and has a chance to close the year at a higher market value than its molecular diagnostics rival. SQNM launched a hostile, all-stock tender offer for EXAS earlier this year for $1.50 per share (which would now be valued at less than 40 cents), but EXACT rejected the deal in favor of a strategic pact with Genzyme (NASDAQ:GENZ) which involved a $24.5M cash infusion. Click here for a link to my comment (pasted below) on a Forbes article that was bullish on SQNM while trading around 25 bucks in late January:
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Video: Investors Experience Gut Level Response To Financial Losses Print E-mail
By Peter Depalma   
Thursday, 30 April 2009 07:05
If watching your financial investments lose money has made you sick to your stomach, there may be a very good reason for it.As a matter of fact, how you handle financial loss may be having a direct biological response in your brain and stomach.New research shows that the same part of your brain that reacts to a terrible smell or frightening experience also reacts wildly to financial losses like those experienced by investors.The gut level response from your brain may also directly affect whether or not you continue to invest in the stock market.The full report can be seen on on-demand below: 
 
BioMed Stock Updates: NASDAQ:RMTI, OTC:PRWP Print E-mail
Wednesday, 29 April 2009 08:50
Rockwell Medical (NASDAQ:RMTI) announced today that patient enrollment is completed for the Company's ongoing Phase 2b dose-ranging study for its iron replacement therapy soluble ferric pyrophosphate (SFP). Below is the entry from RMTI in the BioMedReports.com Clinical Trial Calendar database: RMTI is developing a water soluble iron replacement therapy for dialysis patients called SFP for short (Soluble Ferric Pyrophosphate). Results are expected during 1Q10 for a nine-month NIH study in 30 patients which compares SFP to IV iron replacement therapies. However, this is a non-FDA study and the data will not be considered as part of the application for marketing approval of SFP.
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FDA, Clinical Trial Updates: NYSE:WPI, NASDAQ:UTHR, NASDAQ:AUXL, NASDAQ:DNDN Print E-mail
Tuesday, 28 April 2009 19:21
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
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FDA, Clinical Trial Updates: NYSE:WPI, NYSE:NVS Print E-mail
Tuesday, 28 April 2009 07:28
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted. Watson Pharma (NYSE:WPI) confirmed the filing of an Abbreviated New Drug Application (ANDA), with Paragraph IV litigation underway, which is seeking marketing approval of a generic version of an overactive bladder drug called Enablex (darifenacin). Novartis (NYSE:NVS) has filed a lawsuit to prevent generic competition before the patent expires, causing a stay of final FDA approval for the ANDA for a period of 30 months or court resolution (whichever occurs first). According to IMS Health data, Enablex posted U.S. sales of $220M in 2008. Disclosure: No positions.
 
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