FDA, Clinical Trial Calendar Updates: THOR, ALTH Print E-mail
Monday, 20 April 2009 15:56
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.1.) Thoratec (THOR): Based on previously reported (December 2008) positive interim Phase 3 clinical trial results for its HeartMate II Pump and discussions with the FDA, THOR announced the filing today of a PMA (Pre-Market Approval) supplement seeking to add the intended use of Destination Therapy for the HeartMate II LVAS (left ventricular assist system).
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FDA, Clinical Trial Calendar Updates: DSCO, IPXL Print E-mail
Monday, 20 April 2009 09:38
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.Also check out my profile on Facebook as well as two investing groups for BioMedReports.com and Small/Micro-Cap Investing at the links below.
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Is BioAlliance an Attractive Investment? Print E-mail
Thursday, 16 April 2009 20:09
BioAlliance Pharma (France: BIO.PA) has cash/equivalents as of year-end 2008 that amounted to €31.7 million. Furthermore, and setting aside any new agreements signed in the coming years, BioAlliance Pharma expects to receive up to $21.5 million in milestone payments in 2009-2010 under the terms of its existing licensing and collaboration agreements. The company is also expecting to receive €4 million as a research tax credit.On February 27, 2009, BioAlliance Pharma reacquired the sales rights to Loramyc® in Europe and terminated the exclusive license contract signed in 2007 with the company SpeBio. In order to obtain compensation for losses suffered as a result of delays in commercialization and sale of Loramyc®, BioAlliance Pharma has initiated legal proceedings against SpeBio at the Paris trade tribunal.
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FDA Calendar Stocks on the Move: DSCO, VION, NFLD Print E-mail
Thursday, 16 April 2009 13:41
Below is a summary of updates to the BioMedReports.com database of 241 entries included in the FDA and Clinical Trial Calendars. 1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). The NDA was filed 2/17/09, accepted by FDA for standard, 10-month review on 4/17/09 with a PDUFA decision date of 12/17/09.
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Bill Gates: "We really can make changes when it comes to diseases." Print E-mail
By TED Conference   
Thursday, 16 April 2009 10:00
Bill Gates hopes to solve some of the world's biggest problems using a new kind of philanthropy. Recently, during a passionate and, yes, funny 18 minutes, he asked people to consider two big questions and how we might answer them.A passionate techie and a shrewd businessman, Bill Gates changed the world once, while leading Microsoft to dizzying success. He plans to do it again with his very own style of philanthropy- a plan that put biomedical sciences in the mix.Gates says the market is not driving biomedical solutions the way it ought to be. "There is more money put into baldness cures than into solving the problem of maleria," says Gates. Malaria is decribed as the “King of Diseases” and is considered as the Number One killer infection in the world. There is a threatening increase of mosquitoes and other infections like Dengue and Chikungunya which makes it necessary for us to work towards eradicating the malaria diseases.
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Updated FDA, Clinical Trial Calendars: CTIC, DNDN, MRX, JNJ, MEDX Print E-mail
Tuesday, 14 April 2009 07:10
Below is a summary of updates to the BioMedReports.com database of 241 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 deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 115 entries through 4/14/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.  The Clinical Trial Calendar includes 126 entries through 4/14/09 and 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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EndoRobotics: Expanding Access to Minimally Invasive Surgeries Print E-mail
Monday, 13 April 2009 11:27
EndoRobotics, Inc. is a privately held start-up company formed as part of an exclusive licensing agreement with Columbia University for a breakthrough, patented medical technology to develop and commercialize a first-to-market micro-robotic imaging and surgical device platform to expand the availability of minimally invasive surgeries. On track to be the first micro-robotic imaging and surgical device to market, the technology presents several advantages over traditional laparoscopes and may altogether eliminate their need.  The following is a web link to a six minute video which provides a summary and demonstration of the Company's VisionTrackerOne(TM) medical device technology.
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Updated FDA, Clinical Trial Calendars: CRME, MRK, LLY, PRX Print E-mail
Thursday, 09 April 2009 18:48
Below is a summary of updates to the BioMedReports.com database of 242 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 deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 115 entries through 4/9/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description. 
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A Dozen Extreme FDA Trades on New Product Decisions Print E-mail
Wednesday, 08 April 2009 19:58
Below are 12 companies with market caps below $200M which have pending new drug product decisions at the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced. BioMedReports.com FDA Calendar 1.) Northfield Labs (NFLD): PolyHeme BLA (priority review) for life-threatening red blood cell loss. The FDA accepted the Company's BLA for PolyHeme and granted a priority review in the treatment of life-threatening red blood cell loss with a PDUFA date of 4/30/09.
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Updated FDA, Clinical Trial Calendars: AZN, MYGN, NVS, PSDV Print E-mail
Wednesday, 08 April 2009 15:49
Below is a summary of updates to the BioMedReports.com database of 240 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 deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 113 entries through 4/8/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.  The Clinical Trial Calendar includes 127 entries through 4/8/09 and 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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