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    <title>Healthcare Sector and Stocks Analysis from Seeking Alpha</title>
    <description>'Healthcare' Tag RSS Syndication from SeekingAlpha.com</description>
    <author>
      <name>SeekingAlpha.com</name>
    </author>
    <link>http://seekingalpha.com/sector/healthcare</link>
    <item>
      <title>Pharmas, Hospitals Fall Due to Health Care Reform Troubles</title>
      <link>http://seekingalpha.com/article/148147-pharmas-hospitals-fall-due-to-health-care-reform-troubles?source=feed</link>
      <guid isPermaLink="false">148147</guid>
      <content>
        <![CDATA[<p><span>Rep. Henry Waxman (D-CA) helped depress most drug and hospital stocks Thursday with <a href="http://www.businessword.com/index.php?URL=http%3A%2F%2Fwww.businessword.com%2Findex.php%3F%2Fweblog%2Fcomments%2F2666%2F">his warning</a> that the Obama administration doesn&rsquo;t feel bound by its deal with pharmaceutical companies and that Congress isn&rsquo;t bound by that deal.</span></p><p>The markets obviously didn&rsquo;t believe the White House denial that anyone working there said President Obama isn&rsquo;t bound by the deal he made with drug makers, which made a vague promise to help the government save some $80 billion on drug purchases over the next 10 years.</p>]]>
      </content>
      <pubDate>Fri, 10 Jul 2009 13:48:16 -0400</pubDate>
      <author>Donald Johnson</author>
      <description>
        <![CDATA[<strong><a href='http://www.businessword.com/'>Donald Johnson</a> submits:</strong><p><span>Rep. Henry Waxman (D-CA) helped depress most drug and hospital stocks Thursday with <a href="http://www.businessword.com/index.php?URL=http%3A%2F%2Fwww.businessword.com%2Findex.php%3F%2Fweblog%2Fcomments%2F2666%2F">his warning</a> that the Obama administration doesn&rsquo;t feel bound by its deal with pharmaceutical companies and that Congress isn&rsquo;t bound by that deal.</span></p><p>The markets obviously didn&rsquo;t believe the White House denial that anyone working there said President Obama isn&rsquo;t bound by the deal he made with drug makers, which made a vague promise to help the government save some $80 billion on drug purchases over the next 10 years.</p><br/><a href='http://seekingalpha.com/article/148147-pharmas-hospitals-fall-due-to-health-care-reform-troubles?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/abt">ABT</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/aet">AET</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/hma">HMA</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/jnj">JNJ</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/lly">LLY</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/lpnt">LPNT</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/mrk">MRK</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/pfe">PFE</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/thc">THC</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/uhs">UHS</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/unh">UNH</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/wlp">WLP</category>
      <category type="author" link="http://seekingalpha.com/author/donald-johnson">Donald Johnson</category>
    </item>
    <item>
      <title>Why Healthcare Is a Good Defensive Sector</title>
      <link>http://seekingalpha.com/article/148085-why-healthcare-is-a-good-defensive-sector?source=feed</link>
      <guid isPermaLink="false">148085</guid>
      <content>
        <![CDATA[<p>I recently did an interview with the FT discussing the healthcare sector as a good defensive sector play. I answered of course that healthcare, along with utilities and consumer staples, are the classic defensive sectors. The stocks in those sectors tend to be lower beta and many are mature companies with good cash flow that pay dividends. We own many companies within the sector.</p><p>We watch the sector closely, as the head winds to growth are many, here are a few:</p>]]>
      </content>
      <pubDate>Fri, 10 Jul 2009 09:17:29 -0400</pubDate>
      <author>Andrew Corn</author>
      <description>
        <![CDATA[<img src='http://seekingalpha.com/wp-content/seekingalpha/images/andycorn.jpg' title='andrewcorn' alt='andrewcorn' align="left" hspace="6" vspace="6" width="60" height="64" border='1' /><strong><a href="http://www.clearamideas.com/">Andrew Corn</a> submits: </strong><p>I recently did an interview with the FT discussing the healthcare sector as a good defensive sector play. I answered of course that healthcare, along with utilities and consumer staples, are the classic defensive sectors. The stocks in those sectors tend to be lower beta and many are mature companies with good cash flow that pay dividends. We own many companies within the sector.</p><p>We watch the sector closely, as the head winds to growth are many, here are a few:</p><br/><a href='http://seekingalpha.com/article/148085-why-healthcare-is-a-good-defensive-sector?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/jnj">JNJ</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/mrk">MRK</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/pfe">PFE</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/xlv">XLV</category>
      <category type="author" link="http://seekingalpha.com/author/andrew-corn">Andrew Corn</category>
    </item>
    <item>
      <title>CareView Is a Speculative Buy</title>
      <link>http://seekingalpha.com/article/148028-careview-is-a-speculative-buy?source=feed</link>
      <guid isPermaLink="false">148028</guid>
      <content>
        <![CDATA[<p><font size="3">CareView Communications, Inc. (<a href='http://seekingalpha.com/symbol/crvw.pk' title='More opinion and analysis of CRVW.PK'>CRVW.PK</a>) develops, markets and operates high-speed data network systems that are deployed throughout healthcare facilities using the existing cable television infrastructure of the facility. The systems provide bedside, point-of-care video monitoring and recording as well as providing patients with entertainment, communications and education systems. The Company&rsquo;s systems are suitable for use by a wide variety of healthcare institutions including hospitals, nursing homes, adult living centers and select outpatient care facilities.</font></p><p><font size="3"> </font></p>]]>
      </content>
      <pubDate>Fri, 10 Jul 2009 06:28:32 -0400</pubDate>
      <author>Mike Havrilla</author>
      <description>
        <![CDATA[<strong><a href='http://www.ETFinnovators.com'>Mike Havrilla</a> submits:</strong><p><font size="3">CareView Communications, Inc. (<a href='http://seekingalpha.com/symbol/crvw.pk' title='More opinion and analysis of CRVW.PK'>CRVW.PK</a>) develops, markets and operates high-speed data network systems that are deployed throughout healthcare facilities using the existing cable television infrastructure of the facility. The systems provide bedside, point-of-care video monitoring and recording as well as providing patients with entertainment, communications and education systems. The Company&rsquo;s systems are suitable for use by a wide variety of healthcare institutions including hospitals, nursing homes, adult living centers and select outpatient care facilities.</font></p><p><font size="3"> </font></p><br/><a href='http://seekingalpha.com/article/148028-careview-is-a-speculative-buy?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/crvw.pk">CRVW.PK</category>
      <category type="author" link="http://seekingalpha.com/author/mike-havrilla">Mike Havrilla</category>
    </item>
    <item>
      <title>America's Healthcare Problems Are Making It Less Competitive</title>
      <link>http://seekingalpha.com/article/148019-america-s-healthcare-problems-are-making-it-less-competitive?source=feed</link>
      <guid isPermaLink="false">148019</guid>
      <content>
        <![CDATA[<p><span>The Obama administration is currently working to push healthcare reform down the pipeline at an alarming rate.<span>  </span>The reason for this is that President Obama is trying to make good on his promise that sweeping healthcare reform will be completed by the end of 2009.<span>  </span>I even touched on the fact that this push would come in &ldquo;</span><a href="http://www.commoditynewscenter.com/blogs/Acting_Quickly"><span><font>Acting Quickly</font></span></a><span>&rdquo; from June 15<sup>th</sup>.<span>  </span></span></p><p><span>What&rsquo;s really important here though is not whether or not he meets that deadline.<span>  </span>Hitting that deadline is actually quite irrelevant as the proposed options to fix the system won&rsquo;t address the real problems in health care.<span>  </span>Even worse yet it seems to me that the administration doesn&rsquo;t care that the real problems won&rsquo;t be addressed.<span>  </span>Let&rsquo;s take a look at the healthcare problem, analyze the facts, discuss the proposed solution, and identify what changes <i>REALLY </i>need to be made.</span></p>]]>
      </content>
      <pubDate>Fri, 10 Jul 2009 05:26:30 -0400</pubDate>
      <author>James Bibbings</author>
      <description>
        <![CDATA[<p><span>The Obama administration is currently working to push healthcare reform down the pipeline at an alarming rate.<span>  </span>The reason for this is that President Obama is trying to make good on his promise that sweeping healthcare reform will be completed by the end of 2009.<span>  </span>I even touched on the fact that this push would come in &ldquo;</span><a href="http://www.commoditynewscenter.com/blogs/Acting_Quickly"><span><font>Acting Quickly</font></span></a><span>&rdquo; from June 15<sup>th</sup>.<span>  </span></span></p><p><span>What&rsquo;s really important here though is not whether or not he meets that deadline.<span>  </span>Hitting that deadline is actually quite irrelevant as the proposed options to fix the system won&rsquo;t address the real problems in health care.<span>  </span>Even worse yet it seems to me that the administration doesn&rsquo;t care that the real problems won&rsquo;t be addressed.<span>  </span>Let&rsquo;s take a look at the healthcare problem, analyze the facts, discuss the proposed solution, and identify what changes <i>REALLY </i>need to be made.</span></p><br/><a href='http://seekingalpha.com/article/148019-america-s-healthcare-problems-are-making-it-less-competitive?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/hcn">HCN</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/hcp">HCP</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/hcsg">HCSG</category>
      <category type="author" link="http://seekingalpha.com/author/james-bibbings">James Bibbings</category>
    </item>
    <item>
      <title>FDA Calendar Updates: Rigel Pharma, GlaxoSmithKline, Eisai, SuperGen</title>
      <link>http://seekingalpha.com/article/147896-fda-calendar-updates-rigel-pharma-glaxosmithkline-eisai-supergen?source=feed</link>
      <guid isPermaLink="false">147896</guid>
      <content>
        <![CDATA[<p>Below is a summary of updates to the <a href="http://biomedreports.com/fda-calendar/fda-calendar.html"><font>BioMedReports.com FDA Calendar</font></a>, which includes a database of 250 entries as of 7/9/09. I originally created the calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <a href="http://www.biomedreports.com/"><font>BioMedReports.com</font></a>, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter &#40;CRL&#41; re-submissions to the FDA, and pending late-stage clinical trial results.</p><div> </div><div>On 7/8/09, <b>Spectrum Pharma (NASDAQ:<a href='http://seekingalpha.com/symbol/sppi' title='More opinion and analysis of SPPI'>SPPI</a>)</b> submitted a formal response to the Complete Response Letter &#40;CRL&#41; it received from the FDA 7/2/09 regarding its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin&rsquo;s Lymphoma &#40;NHL&#41; patients. Zevalin is currently FDA approved and marketed by SPPI for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.</div><div> </div><div>The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. CRL resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) reviews by the FDA once they are officially accepted by the Agency. My expectation is for the FDA to formally accept Spectrum's resubmission within 1-2 weeks and classify it as a Class 1 review. The new 60-day review deadline would be 9/8/09 if the Agency agrees with my assessment.</div><div> </div><div>On 7/9/09, <b>Rigel Pharma (NASDAQ:<a href='http://seekingalpha.com/symbol/rigl' title='More opinion and analysis of RIGL'>RIGL</a>)</b> announced that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis &#40;RA&#41; patients in the recently completed TASKi2 Phase 2b clinical trial of 457 patients treated for up to 6 months. Consistent with the previous Phase 2a clinical trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The significant, early and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program with R788 in RA in the first half of 2010 with a corporate partner.</div><div> </div><div>On 7/9/09, <b>GlaxoSmithKline (NYSE:<a href='http://seekingalpha.com/symbol/gsk' title='More opinion and analysis of GSK'>GSK</a>)</b> announced that the World Health Organization &#40;WHO&#41; has approved its cervical cancer vaccine, Cervarix, which allows U.N. agencies to purchase the vaccine for poor countries worldwide. Cervarix represents the second cervical cancer vaccine approved by the WHO, adding to <b>Merck's (NYSE:<a href='http://seekingalpha.com/symbol/mrk' title='More opinion and analysis of MRK'>MRK</a>)</b> Gardasil.</div><div> </div><div>On 3/30/09, GSK submitted final data from its Phase 3 pivotal efficacy study, HPV-008, to the FDA. HPV-008 is a Phase 3 clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and the Americas. The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population. To date, GSK's vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines.</div><div> </div><div>On 7/8/09, <b>Eisai (<a href='http://seekingalpha.com/symbol/esaly.pk' title='More opinion and analysis of ESALY.PK'>ESALY.PK</a>) [TYO:4523]</b> announced that the FDA has accepted for review the company's supplemental new drug application (sNDA) for an alternative five-day dosing regimen for Dacogen (decitabine for injection) to treat patients with myelodysplastic syndromes &#40;MDS&#41;. MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells. Currently, Dacogen is approved for use as a three-day regimen, administered at a dose of 15 mg/m2 via continuous IV infusion over three hours repeated every eight hours for three consecutive days per cycle. The cycle is repeated every six weeks. The alternative five-day dosing regimen of Dacogen submitted to the FDA is a single daily dose with a significantly reduced administration time.</div><div> </div><div><b>SuperGen (NASDAQ:<a href='http://seekingalpha.com/symbol/supg' title='More opinion and analysis of SUPG'>SUPG</a>)</b> receives royalties on Dacogen sales based on a 2004 license agreement entered into with MGI Pharma (which was acquired by Eisai in January 2008) for the exclusive rights to the development, manufacture, commercialization, and distribution of Dacogen. The PDUFA action date for the sNDA is 3/8/10 for a possible FDA decision as part of a 10-month, standard review.</div><div> </div><div><em><strong>Disclosure: No positions.</strong></em></div>]]>
      </content>
      <pubDate>Thu, 09 Jul 2009 10:02:00 -0400</pubDate>
      <author>Mike Havrilla</author>
      <description>
        <![CDATA[<strong><a href='http://www.ETFinnovators.com'>Mike Havrilla</a> submits:</strong><p>Below is a summary of updates to the <a href="http://biomedreports.com/fda-calendar/fda-calendar.html"><font>BioMedReports.com FDA Calendar</font></a>, which includes a database of 250 entries as of 7/9/09. I originally created the calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <a href="http://www.biomedreports.com/"><font>BioMedReports.com</font></a>, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter &#40;CRL&#41; re-submissions to the FDA, and pending late-stage clinical trial results.</p><div> </div><div>On 7/8/09, <b>Spectrum Pharma (NASDAQ:<a href='http://seekingalpha.com/symbol/sppi' title='More opinion and analysis of SPPI'>SPPI</a>)</b> submitted a formal response to the Complete Response Letter &#40;CRL&#41; it received from the FDA 7/2/09 regarding its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin&rsquo;s Lymphoma &#40;NHL&#41; patients. Zevalin is currently FDA approved and marketed by SPPI for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.</div><div> </div><div>The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. CRL resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) reviews by the FDA once they are officially accepted by the Agency. My expectation is for the FDA to formally accept Spectrum's resubmission within 1-2 weeks and classify it as a Class 1 review. The new 60-day review deadline would be 9/8/09 if the Agency agrees with my assessment.</div><div> </div><div>On 7/9/09, <b>Rigel Pharma (NASDAQ:<a href='http://seekingalpha.com/symbol/rigl' title='More opinion and analysis of RIGL'>RIGL</a>)</b> announced that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis &#40;RA&#41; patients in the recently completed TASKi2 Phase 2b clinical trial of 457 patients treated for up to 6 months. Consistent with the previous Phase 2a clinical trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The significant, early and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program with R788 in RA in the first half of 2010 with a corporate partner.</div><div> </div><div>On 7/9/09, <b>GlaxoSmithKline (NYSE:<a href='http://seekingalpha.com/symbol/gsk' title='More opinion and analysis of GSK'>GSK</a>)</b> announced that the World Health Organization &#40;WHO&#41; has approved its cervical cancer vaccine, Cervarix, which allows U.N. agencies to purchase the vaccine for poor countries worldwide. Cervarix represents the second cervical cancer vaccine approved by the WHO, adding to <b>Merck's (NYSE:<a href='http://seekingalpha.com/symbol/mrk' title='More opinion and analysis of MRK'>MRK</a>)</b> Gardasil.</div><div> </div><div>On 3/30/09, GSK submitted final data from its Phase 3 pivotal efficacy study, HPV-008, to the FDA. HPV-008 is a Phase 3 clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and the Americas. The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population. To date, GSK's vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines.</div><div> </div><div>On 7/8/09, <b>Eisai (<a href='http://seekingalpha.com/symbol/esaly.pk' title='More opinion and analysis of ESALY.PK'>ESALY.PK</a>) [TYO:4523]</b> announced that the FDA has accepted for review the company's supplemental new drug application (sNDA) for an alternative five-day dosing regimen for Dacogen (decitabine for injection) to treat patients with myelodysplastic syndromes &#40;MDS&#41;. MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells. Currently, Dacogen is approved for use as a three-day regimen, administered at a dose of 15 mg/m2 via continuous IV infusion over three hours repeated every eight hours for three consecutive days per cycle. The cycle is repeated every six weeks. The alternative five-day dosing regimen of Dacogen submitted to the FDA is a single daily dose with a significantly reduced administration time.</div><div> </div><div><b>SuperGen (NASDAQ:<a href='http://seekingalpha.com/symbol/supg' title='More opinion and analysis of SUPG'>SUPG</a>)</b> receives royalties on Dacogen sales based on a 2004 license agreement entered into with MGI Pharma (which was acquired by Eisai in January 2008) for the exclusive rights to the development, manufacture, commercialization, and distribution of Dacogen. The PDUFA action date for the sNDA is 3/8/10 for a possible FDA decision as part of a 10-month, standard review.</div><div> </div><div><em><strong>Disclosure: No positions.</strong></em></div><br/><a href='http://seekingalpha.com/article/147896-fda-calendar-updates-rigel-pharma-glaxosmithkline-eisai-supergen?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/esaly.pk">ESALY.PK</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/gsk">GSK</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/rigl">RIGL</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/sppi">SPPI</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/supg">SUPG</category>
      <category type="author" link="http://seekingalpha.com/author/mike-havrilla">Mike Havrilla</category>
    </item>
    <item>
      <title>Drug Industry Spending: R&amp;D vs. Marketing</title>
      <link>http://seekingalpha.com/article/147881-drug-industry-spending-r-d-vs-marketing?source=feed</link>
      <guid isPermaLink="false">147881</guid>
      <content>
        <![CDATA[<div><div><div><div><p>Anyone who defends the pharmaceutical industry has to be ready to hear, over and over and over, about how much it spends on sales and marketing versus R&amp;D. This is thought to be a telling point about where the priorities <i>really</i> are. I've addressed this one several times, and my best response is to point out that sales and marketing are actually supposed to <i>bring in more money</i> than you spend on them, and do so more reliably than R&amp;D in the short term.</p>  <p>There's now a very useful paper in <i>Nature Reviews Drug Discovery</i> looking at just this issue. The authors (from three universities in the US and Israel) are looking into the general question of which is the better use of money: put it into R&amp;D for the long term, or promote existing products for the short term? I should make clear at the outset that those two options do line up in that way. R&amp;D expenditures take years to pay off, if ever, given the amount of time that drug development takes. And marketing of a current product had better start paying off in a shorter time frame, because every patented drug is a wasting asset, constantly being eaten into by competition and by its time to patent expiration.</p></div></div></div></div>]]>
      </content>
      <pubDate>Thu, 09 Jul 2009 09:15:13 -0400</pubDate>
      <author>Derek Lowe</author>
      <description>
        <![CDATA[<img src='http://seekingalpha.com/wp-content/seekingalpha/images/dlowe73px.jpg' title='derek lowe' alt='derek lowe' width="73" height="87" align="left" hspace="6" vspace="6" border='1' /><strong><a href="http://pipeline.corante.com/">Derek Lowe</a> submits: </strong><div><div><div><div><p>Anyone who defends the pharmaceutical industry has to be ready to hear, over and over and over, about how much it spends on sales and marketing versus R&amp;D. This is thought to be a telling point about where the priorities <i>really</i> are. I've addressed this one several times, and my best response is to point out that sales and marketing are actually supposed to <i>bring in more money</i> than you spend on them, and do so more reliably than R&amp;D in the short term.</p>  <p>There's now a very useful paper in <i>Nature Reviews Drug Discovery</i> looking at just this issue. The authors (from three universities in the US and Israel) are looking into the general question of which is the better use of money: put it into R&amp;D for the long term, or promote existing products for the short term? I should make clear at the outset that those two options do line up in that way. R&amp;D expenditures take years to pay off, if ever, given the amount of time that drug development takes. And marketing of a current product had better start paying off in a shorter time frame, because every patented drug is a wasting asset, constantly being eaten into by competition and by its time to patent expiration.</p></div></div></div></div><br/><a href='http://seekingalpha.com/article/147881-drug-industry-spending-r-d-vs-marketing?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="author" link="http://seekingalpha.com/author/derek-lowe">Derek Lowe</category>
    </item>
    <item>
      <title>Health Care Reform Stall Cushions Insurers' Fall</title>
      <link>http://seekingalpha.com/article/147872-health-care-reform-stall-cushions-insurers-fall?source=feed</link>
      <guid isPermaLink="false">147872</guid>
      <content>
        <![CDATA[<p><span>The future of health care reform seems to be <a href="http://www.businessword.com/index.php?URL=http%3A%2F%2Fwww.politico.com%2Fnews%2Fstories%2F0709%2F24724.html">so uncertain</a> that speculators in the stocks of health insurers, health care providers, medical device makers and exchange traded funds that track health stock indexes aren&rsquo;t sure which way to turn.</span></p><p>On Wednesday, as expected, health insurers&rsquo; stocks lost part of the gains they made Tuesday when it looked like insurers wouldn&rsquo;t face competition from President Obama&rsquo;s government-run public option health plan, or government HMO. Late Tuesday, Obama reasserted his support for a public option, which is why insurers&rsquo; stocks fell Wednesday.</p>]]>
      </content>
      <pubDate>Thu, 09 Jul 2009 08:44:55 -0400</pubDate>
      <author>Donald Johnson</author>
      <description>
        <![CDATA[<strong><a href='http://www.businessword.com/'>Donald Johnson</a> submits:</strong><p><span>The future of health care reform seems to be <a href="http://www.businessword.com/index.php?URL=http%3A%2F%2Fwww.politico.com%2Fnews%2Fstories%2F0709%2F24724.html">so uncertain</a> that speculators in the stocks of health insurers, health care providers, medical device makers and exchange traded funds that track health stock indexes aren&rsquo;t sure which way to turn.</span></p><p>On Wednesday, as expected, health insurers&rsquo; stocks lost part of the gains they made Tuesday when it looked like insurers wouldn&rsquo;t face competition from President Obama&rsquo;s government-run public option health plan, or government HMO. Late Tuesday, Obama reasserted his support for a public option, which is why insurers&rsquo; stocks fell Wednesday.</p><br/><a href='http://seekingalpha.com/article/147872-health-care-reform-stall-cushions-insurers-fall?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/aet">AET</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/ci">CI</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/cvh">CVH</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/hs">HS</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/hum">HUM</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/iyh">IYH</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/unh">UNH</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/vht">VHT</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/wlp">WLP</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/xlv">XLV</category>
      <category type="author" link="http://seekingalpha.com/author/donald-johnson">Donald Johnson</category>
    </item>
    <item>
      <title>5 IPOs with Strong Starts</title>
      <link>http://seekingalpha.com/article/147840-5-ipos-with-strong-starts?source=feed</link>
      <guid isPermaLink="false">147840</guid>
      <content>
        <![CDATA[<p>Despite beginning the year in one of the worst recessions in years, the IPO market been surprisingly strong with a diverse group of companies hitting the Street running. Of the IPOs that began trading in 2009, a large number are China-related. The market is passed the stage of pushing every stock with the word China in its name higher, but the real growth continues to be heavily populated country. A breakdown of a few of the IPOs is below.</p> <p><strong>Duoyuan Global Water (<a href='http://seekingalpha.com/symbol/dgw' title='More opinion and analysis of DGW'>DGW</a>)</strong> - Began trading on 6/24 after pricing at $16 per share. The stock ran up to the mid-$20&rsquo;s in the first week of trading and has held steady since. The company is a maker of water treatment equipment in China that includes wastewater treatment and water purification. One of my favorite long-term investment themes involves water and water-related stocks. The ties DGW has to China make the stock even more attractive because the country has major water issues and will have to address them in the years to come. The most recent Chinese stimulus package is actually going after upgrading infrastructure and will be a boost for DGW.</p>]]>
      </content>
      <pubDate>Thu, 09 Jul 2009 07:46:33 -0400</pubDate>
      <author>Matthew D. McCall</author>
      <description>
        <![CDATA[<p>Despite beginning the year in one of the worst recessions in years, the IPO market been surprisingly strong with a diverse group of companies hitting the Street running. Of the IPOs that began trading in 2009, a large number are China-related. The market is passed the stage of pushing every stock with the word China in its name higher, but the real growth continues to be heavily populated country. A breakdown of a few of the IPOs is below.</p> <p><strong>Duoyuan Global Water (<a href='http://seekingalpha.com/symbol/dgw' title='More opinion and analysis of DGW'>DGW</a>)</strong> - Began trading on 6/24 after pricing at $16 per share. The stock ran up to the mid-$20&rsquo;s in the first week of trading and has held steady since. The company is a maker of water treatment equipment in China that includes wastewater treatment and water purification. One of my favorite long-term investment themes involves water and water-related stocks. The ties DGW has to China make the stock even more attractive because the country has major water issues and will have to address them in the years to come. The most recent Chinese stimulus package is actually going after upgrading infrastructure and will be a boost for DGW.</p><br/><a href='http://seekingalpha.com/article/147840-5-ipos-with-strong-starts?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/bpi">BPI</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/cyou">CYOU</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/dgw">DGW</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/mjn">MJN</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/rst">RST</category>
      <category type="author" link="http://seekingalpha.com/author/matthew-d.-mccall">Matthew D. McCall</category>
    </item>
    <item>
      <title>Eclipsys: Uncertainty Eclipses an Optimistic Outlook</title>
      <link>http://seekingalpha.com/article/147810-eclipsys-uncertainty-eclipses-an-optimistic-outlook?source=feed</link>
      <guid isPermaLink="false">147810</guid>
      <content>
        <![CDATA[<p><span>Investors have been looking for a seat on the healthcare information technology gravy train. Ever since the American Recovery and Reinvestment Act of 2009 was passed in February, the healthcare IT sector has rallied and outperformed the broader market (See Figure 1). Contained within the ARRA is the HITECH Act, a piece of legislation designed to incent medical providers to install and use IT systems for the delivery of better care. The legislation sets forth an estimated $19B in publicly funded grant &amp; loan programs and Medicare/Medicaid incentive payments which will be distributed to medical providers who are &ldquo;meaningful users&rdquo; of healthcare information technology.<br> <br> <a href="http://static.seekingalpha.com/uploads/2009/7/9/saupload_w1.png" rel="lightbox"><img src="http://static.seekingalpha.com/uploads/2009/7/9/saupload_w1_thumb1.png" hspace="6" vspace="6" /></a></span></p>]]>
      </content>
      <pubDate>Thu, 09 Jul 2009 07:09:17 -0400</pubDate>
      <author>Winston Kotzan</author>
      <description>
        <![CDATA[<p><span>Investors have been looking for a seat on the healthcare information technology gravy train. Ever since the American Recovery and Reinvestment Act of 2009 was passed in February, the healthcare IT sector has rallied and outperformed the broader market (See Figure 1). Contained within the ARRA is the HITECH Act, a piece of legislation designed to incent medical providers to install and use IT systems for the delivery of better care. The legislation sets forth an estimated $19B in publicly funded grant &amp; loan programs and Medicare/Medicaid incentive payments which will be distributed to medical providers who are &ldquo;meaningful users&rdquo; of healthcare information technology.<br> <br> <a href="http://static.seekingalpha.com/uploads/2009/7/9/saupload_w1.png" rel="lightbox"><img src="http://static.seekingalpha.com/uploads/2009/7/9/saupload_w1_thumb1.png" hspace="6" vspace="6" /></a></span></p><br/><a href='http://seekingalpha.com/article/147810-eclipsys-uncertainty-eclipses-an-optimistic-outlook?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/athn">ATHN</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/cern">CERN</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/cpsi">CPSI</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/eclp">ECLP</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/mck">MCK</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/mdrx">MDRX</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/qsii">QSII</category>
      <category type="author" link="http://seekingalpha.com/author/winston-kotzan">Winston Kotzan</category>
    </item>
    <item>
      <title>Wal-Mart, Healthcare and Large Cap Outperformance</title>
      <link>http://seekingalpha.com/article/147823-wal-mart-healthcare-and-large-cap-outperformance?source=feed</link>
      <guid isPermaLink="false">147823</guid>
      <content>
        <![CDATA[<p>Wal-Mart (<a href='http://seekingalpha.com/symbol/wmt' title='More opinion and analysis of WMT'>WMT</a>) made headlines last week by endorsing proposals in Washington that mandate employer-provided health insurance.  Fox News anchor Elizabeth MacDonald does a good job analyzing the retail giant&rsquo;s motives in <a href="http://emac.blogs.foxbusiness.com/2009/07/02/wal-marts-health-reform-gambit/">her blog post</a> and identifies competitive advantages that Wal-Mart would enjoy if this coverage were legally required.  In essence, because Wal-Mart already covers many employees and has the pricing power of an enormous company, new universal mandates are more crippling to its competitors.  MacDonald also argues that, by stepping forward now, Wal-Mart ensures a seat at the political table in shaping the legislation, ensuring that the law will be relatively beneficial to the company.</p> <p>Wal-Mart&rsquo;s actions are a good example of the way that large companies, with their deep pockets and legions of lobbyists, can influence new regulations and legislation to their advantage at the expense of smaller competitors.  The more regulation created, the more the potential for this type of mischief.  This is not to pass judgment on the merits of the issue, but only to observe how large corporations can influence legislation in their favor better than smaller companies, and the more regulation, the greater the potential advantage.</p>]]>
      </content>
      <pubDate>Thu, 09 Jul 2009 07:09:02 -0400</pubDate>
      <author>Jeffrey Korzenik</author>
      <description>
        <![CDATA[<strong><a href='http://inefficientfrontiers.wordpress.com'>Jeffrey Korzenik</a> submits: </strong><p>Wal-Mart (<a href='http://seekingalpha.com/symbol/wmt' title='More opinion and analysis of WMT'>WMT</a>) made headlines last week by endorsing proposals in Washington that mandate employer-provided health insurance.  Fox News anchor Elizabeth MacDonald does a good job analyzing the retail giant&rsquo;s motives in <a href="http://emac.blogs.foxbusiness.com/2009/07/02/wal-marts-health-reform-gambit/">her blog post</a> and identifies competitive advantages that Wal-Mart would enjoy if this coverage were legally required.  In essence, because Wal-Mart already covers many employees and has the pricing power of an enormous company, new universal mandates are more crippling to its competitors.  MacDonald also argues that, by stepping forward now, Wal-Mart ensures a seat at the political table in shaping the legislation, ensuring that the law will be relatively beneficial to the company.</p> <p>Wal-Mart&rsquo;s actions are a good example of the way that large companies, with their deep pockets and legions of lobbyists, can influence new regulations and legislation to their advantage at the expense of smaller competitors.  The more regulation created, the more the potential for this type of mischief.  This is not to pass judgment on the merits of the issue, but only to observe how large corporations can influence legislation in their favor better than smaller companies, and the more regulation, the greater the potential advantage.</p><br/><a href='http://seekingalpha.com/article/147823-wal-mart-healthcare-and-large-cap-outperformance?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/wmt">WMT</category>
      <category type="author" link="http://seekingalpha.com/author/jeffrey-korzenik">Jeffrey Korzenik</category>
    </item>
    <item>
      <title>FDA Calendar Updates: Amgen, Bayer, Biogen, Noveko, Peplin, Transdel</title>
      <link>http://seekingalpha.com/article/147763-fda-calendar-updates-amgen-bayer-biogen-noveko-peplin-transdel?source=feed</link>
      <guid isPermaLink="false">147763</guid>
      <content>
        <![CDATA[<p>Below is a summary of updates to the <a href="http://biomedreports.com/fda-calendar/fda-calendar.html"><font>BioMedReports.com FDA Calendar</font></a>, which includes a database of 246 entries as of 7/8/09. I originally created this calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <a href="http://www.biomedreports.com/"><font>BioMedReports.com</font></a>, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (<a href='http://seekingalpha.com/symbol/crl' title='More opinion and analysis of CRL'>CRL</a>) re-submissions to the FDA, and pending late-stage clinical trial results.</p><div> </div><div>On 7/8/09, <b>Bayer (<a href='http://seekingalpha.com/symbol/bayry.pk' title='More opinion and analysis of BAYRY.PK'>BAYRY.PK</a>)</b> announced the submission of a New Drug Application &#40;NDA&#41; to the FDA for a new estradiol-based oral contraceptive (estradiol valerate/dienogest). It seeks approval for the indications oral contraception and treatment of heavy and/or prolonged menstrual bleeding. The new product with an estradiol valerate/dienogest combination is the first in a new class of oral contraceptives to deliver estradiol, the estrogen identical to the one produced by the female body. It is marketed in Europe under the tradename Qlaira. The estimated PDUFA action date for a standard, 10-month review by the FDA for this NDA is 5/8/10.</div><div> </div><div><b>Amgen (NASDAQ:<a href='http://seekingalpha.com/symbol/amgn' title='More opinion and analysis of AMGN'>AMGN</a>)</b> has a pending BLA for denosumab with a PDUFA action date of 10/19/09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen&rsquo;s experimental osteoporosis drug denosumab (proposed brand name Prolia) will be revied by an Advisory Panel at a meeting on 8/13/09. The FDA Advisory Panel will discuss the Company's proposed uses of (1) treating and preventing osteoporosis in post-menopausal women and (2) treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.</div><div> </div><div>On 7/7/09, AMGN announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events, and delaying the time to the first-and-subsequent SREs. Both results were statistically significant.</div><div> </div><div>On 7/8/09, <b>Biogen Idec (NASDAQ:<a href='http://seekingalpha.com/symbol/biib' title='More opinion and analysis of BIIB'>BIIB</a>)</b> announced that the FDA granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis &#40;RMS&#41;. BIIB is currently enrolling patients in a global Phase 3 study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population. BIIB plans to enroll more than 1,200 patients in the Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a in patients with RMS. The global trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS at one year.</div><div> </div><div> </div><div>On 7/8/09, <b>Peplin [ASX:PLI]</b> announced the completion of enrolment of its two Phase 3 clinical trials for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses &#40;AK&#41;, a common pre-cancerous skin lesion, on head treatment areas, which include the face and scalp. These Phase 3 clinical trials are referred to as REGION-IIa and REGION-IIb and enrolled approximately 250 patients each. Peplin plans to announce the REGION-II trial results during 4Q09. In addition to the REGION-II trials on head locations, Peplin recently completed its REGION-Ia trial for non-head locations, which included the trunk and extremities, and plans to initiate the REGION-Ib trial during 3Q09 to corroborate the results of the previously completed trial and expects to file a New Drug Application in mid-2010.</div><div> </div><div>On 7/8/09, <b>Transdel Pharma (<a href='http://seekingalpha.com/symbol/tdlp.ob' title='More opinion and analysis of TDLP.OB'>TDLP.OB</a>)</b> announced the successful completion of patient enrollment in a pivotal Phase 3 clinical study for Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory drug &#40;NSAID&#41; for the treatment of acute pain. As previously announced, TDLP.OB expects to report the top-line results from this Phase 3 trial later in 3Q09. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.</div><div> </div><div>On 7/8/09, <b>Noveko (<a href='http://seekingalpha.com/symbol/nkoff.pk' title='More opinion and analysis of NKOFF.PK'>NKOFF.PK</a>)</b> announced that its management recently held constructive discussions with the FDA regarding its pending 510(k) submission for the Noveko 3xEZ Antibacterial Surgical Mask to obtain clarifications on and narrow FDA's remaining data requests so that the Company can timely respond to them. As such, the Company received confirmation that it has now until 10/23/09 to submit the requested remaining data. The Company believes that when the 510(k) is cleared for the Noveko 3xEZ Antibacterial Surgical Mask, it will likely be the first mover in the U.S. market, further protected by its underlying product patent portfolio.</div><div> </div><div><em><strong>Disclosure: No positions.</strong></em></div>]]>
      </content>
      <pubDate>Thu, 09 Jul 2009 03:13:27 -0400</pubDate>
      <author>Mike Havrilla</author>
      <description>
        <![CDATA[<strong><a href='http://www.ETFinnovators.com'>Mike Havrilla</a> submits:</strong><p>Below is a summary of updates to the <a href="http://biomedreports.com/fda-calendar/fda-calendar.html"><font>BioMedReports.com FDA Calendar</font></a>, which includes a database of 246 entries as of 7/8/09. I originally created this calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <a href="http://www.biomedreports.com/"><font>BioMedReports.com</font></a>, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (<a href='http://seekingalpha.com/symbol/crl' title='More opinion and analysis of CRL'>CRL</a>) re-submissions to the FDA, and pending late-stage clinical trial results.</p><div> </div><div>On 7/8/09, <b>Bayer (<a href='http://seekingalpha.com/symbol/bayry.pk' title='More opinion and analysis of BAYRY.PK'>BAYRY.PK</a>)</b> announced the submission of a New Drug Application &#40;NDA&#41; to the FDA for a new estradiol-based oral contraceptive (estradiol valerate/dienogest). It seeks approval for the indications oral contraception and treatment of heavy and/or prolonged menstrual bleeding. The new product with an estradiol valerate/dienogest combination is the first in a new class of oral contraceptives to deliver estradiol, the estrogen identical to the one produced by the female body. It is marketed in Europe under the tradename Qlaira. The estimated PDUFA action date for a standard, 10-month review by the FDA for this NDA is 5/8/10.</div><div> </div><div><b>Amgen (NASDAQ:<a href='http://seekingalpha.com/symbol/amgn' title='More opinion and analysis of AMGN'>AMGN</a>)</b> has a pending BLA for denosumab with a PDUFA action date of 10/19/09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen&rsquo;s experimental osteoporosis drug denosumab (proposed brand name Prolia) will be revied by an Advisory Panel at a meeting on 8/13/09. The FDA Advisory Panel will discuss the Company's proposed uses of (1) treating and preventing osteoporosis in post-menopausal women and (2) treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.</div><div> </div><div>On 7/7/09, AMGN announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events, and delaying the time to the first-and-subsequent SREs. Both results were statistically significant.</div><div> </div><div>On 7/8/09, <b>Biogen Idec (NASDAQ:<a href='http://seekingalpha.com/symbol/biib' title='More opinion and analysis of BIIB'>BIIB</a>)</b> announced that the FDA granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis &#40;RMS&#41;. BIIB is currently enrolling patients in a global Phase 3 study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population. BIIB plans to enroll more than 1,200 patients in the Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a in patients with RMS. The global trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS at one year.</div><div> </div><div> </div><div>On 7/8/09, <b>Peplin [ASX:PLI]</b> announced the completion of enrolment of its two Phase 3 clinical trials for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses &#40;AK&#41;, a common pre-cancerous skin lesion, on head treatment areas, which include the face and scalp. These Phase 3 clinical trials are referred to as REGION-IIa and REGION-IIb and enrolled approximately 250 patients each. Peplin plans to announce the REGION-II trial results during 4Q09. In addition to the REGION-II trials on head locations, Peplin recently completed its REGION-Ia trial for non-head locations, which included the trunk and extremities, and plans to initiate the REGION-Ib trial during 3Q09 to corroborate the results of the previously completed trial and expects to file a New Drug Application in mid-2010.</div><div> </div><div>On 7/8/09, <b>Transdel Pharma (<a href='http://seekingalpha.com/symbol/tdlp.ob' title='More opinion and analysis of TDLP.OB'>TDLP.OB</a>)</b> announced the successful completion of patient enrollment in a pivotal Phase 3 clinical study for Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory drug &#40;NSAID&#41; for the treatment of acute pain. As previously announced, TDLP.OB expects to report the top-line results from this Phase 3 trial later in 3Q09. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.</div><div> </div><div>On 7/8/09, <b>Noveko (<a href='http://seekingalpha.com/symbol/nkoff.pk' title='More opinion and analysis of NKOFF.PK'>NKOFF.PK</a>)</b> announced that its management recently held constructive discussions with the FDA regarding its pending 510(k) submission for the Noveko 3xEZ Antibacterial Surgical Mask to obtain clarifications on and narrow FDA's remaining data requests so that the Company can timely respond to them. As such, the Company received confirmation that it has now until 10/23/09 to submit the requested remaining data. The Company believes that when the 510(k) is cleared for the Noveko 3xEZ Antibacterial Surgical Mask, it will likely be the first mover in the U.S. market, further protected by its underlying product patent portfolio.</div><div> </div><div><em><strong>Disclosure: No positions.</strong></em></div><br/><a href='http://seekingalpha.com/article/147763-fda-calendar-updates-amgen-bayer-biogen-noveko-peplin-transdel?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/amgn">AMGN</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/bayry.pk">BAYRY.PK</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/biib">BIIB</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/nkoff.pk">NKOFF.PK</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/tdlp.ob">TDLP.OB</category>
      <category type="author" link="http://seekingalpha.com/author/mike-havrilla">Mike Havrilla</category>
    </item>
    <item>
      <title>Health Insurers Under Attack Again</title>
      <link>http://seekingalpha.com/article/147592-health-insurers-under-attack-again?source=feed</link>
      <guid isPermaLink="false">147592</guid>
      <content>
        <![CDATA[<p>Health insurers&rsquo; stock prices are likely to fall Wednesday. Most of them rose smartly Tuesday on news that President Obama would accept a health bill without a public option health plan.</p> <p>But not only did the left get to Obama and force him to reassert his demands for a public option health plan, or Government HMO, Senate Majority leader Harry Reid (D-NV) told Sen. Max Baucus (D-MT) that the health bill must include the Government HMO.</p>]]>
      </content>
      <pubDate>Wed, 08 Jul 2009 06:24:02 -0400</pubDate>
      <author>Donald Johnson</author>
      <description>
        <![CDATA[<strong><a href='http://www.businessword.com/'>Donald Johnson</a> submits:</strong><p>Health insurers&rsquo; stock prices are likely to fall Wednesday. Most of them rose smartly Tuesday on news that President Obama would accept a health bill without a public option health plan.</p> <p>But not only did the left get to Obama and force him to reassert his demands for a public option health plan, or Government HMO, Senate Majority leader Harry Reid (D-NV) told Sen. Max Baucus (D-MT) that the health bill must include the Government HMO.</p><br/><a href='http://seekingalpha.com/article/147592-health-insurers-under-attack-again?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/aet">AET</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/ci">CI</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/cvh">CVH</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/hs">HS</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/hum">HUM</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/iyh">IYH</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/unh">UNH</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/vht">VHT</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/wlp">WLP</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/xlv">XLV</category>
      <category type="author" link="http://seekingalpha.com/author/donald-johnson">Donald Johnson</category>
    </item>
    <item>
      <title>Intuitive Surgical: Great Technology, Tough Environment</title>
      <link>http://seekingalpha.com/article/147521-intuitive-surgical-great-technology-tough-environment?source=feed</link>
      <guid isPermaLink="false">147521</guid>
      <content>
        <![CDATA[<p><span>Medical device maker, Intuitive Surgical Inc. (<a href='http://seekingalpha.com/symbol/isrg' title='More opinion and analysis of ISRG'>ISRG</a>), produces the robotic da Vinci System used in urological and gynecological surgeries. The da Vinci system has single-handedly transformed the way urologists have approached prostrate surgery over the past 5 years. ISRG has recently made in-roads in additional modalities such as gynecological and cardiothoracic surgeries, positioning the company for continued growth in this competitive field.<span>  </span></span></p> <p><span> </span></p>]]>
      </content>
      <pubDate>Wed, 08 Jul 2009 03:49:08 -0400</pubDate>
      <author>The Inflection Point</author>
      <description>
        <![CDATA[<p><span>Medical device maker, Intuitive Surgical Inc. (<a href='http://seekingalpha.com/symbol/isrg' title='More opinion and analysis of ISRG'>ISRG</a>), produces the robotic da Vinci System used in urological and gynecological surgeries. The da Vinci system has single-handedly transformed the way urologists have approached prostrate surgery over the past 5 years. ISRG has recently made in-roads in additional modalities such as gynecological and cardiothoracic surgeries, positioning the company for continued growth in this competitive field.<span>  </span></span></p> <p><span> </span></p><br/><a href='http://seekingalpha.com/article/147521-intuitive-surgical-great-technology-tough-environment?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/ilmn">ILMN</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/isrg">ISRG</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/mygn">MYGN</category>
      <category type="author" link="http://seekingalpha.com/author/the-inflection-point">The Inflection Point</category>
    </item>
    <item>
      <title>FDA Calendar Updates: King Pharma, Pain Therapeutics </title>
      <link>http://seekingalpha.com/article/147518-fda-calendar-updates-king-pharma-pain-therapeutics?source=feed</link>
      <guid isPermaLink="false">147518</guid>
      <content>
        <![CDATA[<p>Below is a summary of updates to the <a href="http://biomedreports.com/fda-calendar/fda-calendar.html"><font>BioMedReports.com FDA Calendar</font></a>, which includes a database of 243 entries as of 7/7/09. 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 <a href="http://www.biomedreports.com/"><font>BioMedReports.com</font></a>, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter &#40;CRL&#41; re-submissions to the FDA, and pending late-stage clinical trial results.</p><div> </div><div>On 7/7/09, <b>King Pharma (NYSE:<a href='http://seekingalpha.com/symbol/kg' title='More opinion and analysis of KG'>KG</a>)</b> and <b>Pain Therapeutics (NASDAQ:<a href='http://seekingalpha.com/symbol/ptie' title='More opinion and analysis of PTIE'>PTIE</a>)</b> announced that KG met with the FDA on 7/2/09 to discuss the Complete Response Letter &#40;CRL&#41; for the Remoxy NDA.KG expects the resubmission of the NDA to occur mid-year 2010 and believes that the rate limiting step is the generation of six-month stability data, and no new clinical trials are required.</div><div> </div><div>Remoxy is based on <b>Durect's (NASDAQ:<a href='http://seekingalpha.com/symbol/drrx' title='More opinion and analysis of DRRX'>DRRX</a>)</b> Oradur technology as a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. In mid-2008, an NDA for Remoxy was accepted by the FDA and granted Priority Review. In December 2008, PTIE received a CRL from the FDA, and subsequently, KG assumed full control of all activities related to the development of Remoxy.</div><div> </div><div>On 7/7/09, <b>Allos Therapeutics (NASDAQ:<a href='http://seekingalpha.com/symbol/alth' title='More opinion and analysis of ALTH'>ALTH</a>)</b> announced the completion of patient enrollment in the Company's randomized Phase 2b clinical trial comparing pralatrexate to erlotinib (Tarceva) in patients with Stage IIIB/IV non-small cell lung cancer &#40;NSCLC&#41; who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen. This randomized, open-label, international, multi-center Phase 2b trial was initiated in January 2008 and enrolled 201 patients.</div><div> </div><div>The objective of the trial is to compare the efficacy of pralatrexate to that of erlotinib in patients with Stage IIIB/IV NSCLC who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen, including subsets of light and heavy smokers, as well as current and former smokers. Per the protocol, the primary endpoint is overall survival. Response rate, progression-free survival and the safety and tolerability of pralatrexate will also be assessed. Patients were randomized 1:1 to receive either pralatrexate or erlotinib. The primary survival analysis will be performed when a pre-specified number of events have occurred in all randomized patients.</div><div> </div><div>On 7/7/09, <b>Trinity Biotech (NASDAQ:<a href='http://seekingalpha.com/symbol/trib' title='More opinion and analysis of TRIB'>TRIB</a>)</b> announced the FDA approval and U.S. launch of its high throughput haemostasis (blood clot) analyzer, the Destiny Max. On 3/9/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient's average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval.</div><div> </div><div>On 7/6/09, <b>Cubist Pharma (NASDAQ:<a href='http://seekingalpha.com/symbol/cbst' title='More opinion and analysis of CBST'>CBST</a>)</b> announced that it began dosing in the CONSERV-2 clinical trial with ecallantide. CONSERV-2, being conducted in Europe, is a Phase 2 trial that will investigate ecallantide&rsquo;s effect on surgical blood loss volume in cardiac surgery patients who are on cardiopulmonary bypass and are at a high risk of bleeding. The trial is expected to enroll 300 subjects. Ecallantide is a potent inhibitor of plasma kallikrein, and CONSERV-2 will evaluate the effects of plasma kallikrein inhibition in the trial population. Surgical environments, such as those involving the trial population, are associated with the activation of plasma kallikrein and subsequent activation of coagulation, fibrinolytic, and inflammatory cascades, which likely contribute to blood loss and blood transfusion requirements in the perioperative setting.</div><div> </div><div>CBST stated that it remains on track for a mid-2010 end-of-phase 2 meeting with the FDA and anticipates that the results of this trial and the ongoing CONSERV-1 trial will provide meaningful insights into the optimal design of subsequent Phase 3 trials. In April 2008, Cubist announced an exclusive North American and European license and collaboration agreement with <b>Dyax Corp. (NASDAQ: <a href='http://seekingalpha.com/symbol/dyax' title='More opinion and analysis of DYAX'>DYAX</a>) </b>for the development and commercialization of the intravenous formulation of ecallantide for surgical indications. The first indication being sought by Cubist for ecallantide is the reduction of blood loss during on-pump cardiac surgery.</div><div> </div><div><em><strong>Disclosure: No positions.</strong></em></div>]]>
      </content>
      <pubDate>Wed, 08 Jul 2009 03:44:26 -0400</pubDate>
      <author>Mike Havrilla</author>
      <description>
        <![CDATA[<strong><a href='http://www.ETFinnovators.com'>Mike Havrilla</a> submits:</strong><p>Below is a summary of updates to the <a href="http://biomedreports.com/fda-calendar/fda-calendar.html"><font>BioMedReports.com FDA Calendar</font></a>, which includes a database of 243 entries as of 7/7/09. 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 <a href="http://www.biomedreports.com/"><font>BioMedReports.com</font></a>, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter &#40;CRL&#41; re-submissions to the FDA, and pending late-stage clinical trial results.</p><div> </div><div>On 7/7/09, <b>King Pharma (NYSE:<a href='http://seekingalpha.com/symbol/kg' title='More opinion and analysis of KG'>KG</a>)</b> and <b>Pain Therapeutics (NASDAQ:<a href='http://seekingalpha.com/symbol/ptie' title='More opinion and analysis of PTIE'>PTIE</a>)</b> announced that KG met with the FDA on 7/2/09 to discuss the Complete Response Letter &#40;CRL&#41; for the Remoxy NDA.KG expects the resubmission of the NDA to occur mid-year 2010 and believes that the rate limiting step is the generation of six-month stability data, and no new clinical trials are required.</div><div> </div><div>Remoxy is based on <b>Durect's (NASDAQ:<a href='http://seekingalpha.com/symbol/drrx' title='More opinion and analysis of DRRX'>DRRX</a>)</b> Oradur technology as a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. In mid-2008, an NDA for Remoxy was accepted by the FDA and granted Priority Review. In December 2008, PTIE received a CRL from the FDA, and subsequently, KG assumed full control of all activities related to the development of Remoxy.</div><div> </div><div>On 7/7/09, <b>Allos Therapeutics (NASDAQ:<a href='http://seekingalpha.com/symbol/alth' title='More opinion and analysis of ALTH'>ALTH</a>)</b> announced the completion of patient enrollment in the Company's randomized Phase 2b clinical trial comparing pralatrexate to erlotinib (Tarceva) in patients with Stage IIIB/IV non-small cell lung cancer &#40;NSCLC&#41; who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen. This randomized, open-label, international, multi-center Phase 2b trial was initiated in January 2008 and enrolled 201 patients.</div><div> </div><div>The objective of the trial is to compare the efficacy of pralatrexate to that of erlotinib in patients with Stage IIIB/IV NSCLC who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen, including subsets of light and heavy smokers, as well as current and former smokers. Per the protocol, the primary endpoint is overall survival. Response rate, progression-free survival and the safety and tolerability of pralatrexate will also be assessed. Patients were randomized 1:1 to receive either pralatrexate or erlotinib. The primary survival analysis will be performed when a pre-specified number of events have occurred in all randomized patients.</div><div> </div><div>On 7/7/09, <b>Trinity Biotech (NASDAQ:<a href='http://seekingalpha.com/symbol/trib' title='More opinion and analysis of TRIB'>TRIB</a>)</b> announced the FDA approval and U.S. launch of its high throughput haemostasis (blood clot) analyzer, the Destiny Max. On 3/9/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient's average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval.</div><div> </div><div>On 7/6/09, <b>Cubist Pharma (NASDAQ:<a href='http://seekingalpha.com/symbol/cbst' title='More opinion and analysis of CBST'>CBST</a>)</b> announced that it began dosing in the CONSERV-2 clinical trial with ecallantide. CONSERV-2, being conducted in Europe, is a Phase 2 trial that will investigate ecallantide&rsquo;s effect on surgical blood loss volume in cardiac surgery patients who are on cardiopulmonary bypass and are at a high risk of bleeding. The trial is expected to enroll 300 subjects. Ecallantide is a potent inhibitor of plasma kallikrein, and CONSERV-2 will evaluate the effects of plasma kallikrein inhibition in the trial population. Surgical environments, such as those involving the trial population, are associated with the activation of plasma kallikrein and subsequent activation of coagulation, fibrinolytic, and inflammatory cascades, which likely contribute to blood loss and blood transfusion requirements in the perioperative setting.</div><div> </div><div>CBST stated that it remains on track for a mid-2010 end-of-phase 2 meeting with the FDA and anticipates that the results of this trial and the ongoing CONSERV-1 trial will provide meaningful insights into the optimal design of subsequent Phase 3 trials. In April 2008, Cubist announced an exclusive North American and European license and collaboration agreement with <b>Dyax Corp. (NASDAQ: <a href='http://seekingalpha.com/symbol/dyax' title='More opinion and analysis of DYAX'>DYAX</a>) </b>for the development and commercialization of the intravenous formulation of ecallantide for surgical indications. The first indication being sought by Cubist for ecallantide is the reduction of blood loss during on-pump cardiac surgery.</div><div> </div><div><em><strong>Disclosure: No positions.</strong></em></div><br/><a href='http://seekingalpha.com/article/147518-fda-calendar-updates-king-pharma-pain-therapeutics?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/alth">ALTH</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/cbst">CBST</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/drrx">DRRX</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/dyax">DYAX</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/kg">KG</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/ptie">PTIE</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/trib">TRIB</category>
      <category type="author" link="http://seekingalpha.com/author/mike-havrilla">Mike Havrilla</category>
    </item>
    <item>
      <title>Electro-Optical Sciences: A Speculative Stock with Great Potential </title>
      <link>http://seekingalpha.com/article/147433-electro-optical-sciences-a-speculative-stock-with-great-potential?source=feed</link>
      <guid isPermaLink="false">147433</guid>
      <content>
        <![CDATA[<p>My stock suggestion today is in the spirit of adventure. It&rsquo;s a medical technology company that doesn&rsquo;t really have revenues, much less earnings, and it doesn&rsquo;t have a product approved for sale. What it has is a great idea for a hand-held device that will enable dermatologists to scan skin lesions to determine whether they are melanomas.</p> <p>The company is Electro-Optical Sciences (<a href='http://seekingalpha.com/symbol/mela' title='More opinion and analysis of MELA'>MELA</a>), and the device-called the MelaFind-uses light at various wave-lengths to scan the suspicious lesion. It then uses its database of melanoma images to calculate a diagnosis.</p>]]>
      </content>
      <pubDate>Tue, 07 Jul 2009 12:47:27 -0400</pubDate>
      <author>Paul Goodwin</author>
      <description>
        <![CDATA[<strong><a href='http://www.cabot.net/'>Paul Goodwin</a> submits: </strong><p>My stock suggestion today is in the spirit of adventure. It&rsquo;s a medical technology company that doesn&rsquo;t really have revenues, much less earnings, and it doesn&rsquo;t have a product approved for sale. What it has is a great idea for a hand-held device that will enable dermatologists to scan skin lesions to determine whether they are melanomas.</p> <p>The company is Electro-Optical Sciences (<a href='http://seekingalpha.com/symbol/mela' title='More opinion and analysis of MELA'>MELA</a>), and the device-called the MelaFind-uses light at various wave-lengths to scan the suspicious lesion. It then uses its database of melanoma images to calculate a diagnosis.</p><br/><a href='http://seekingalpha.com/article/147433-electro-optical-sciences-a-speculative-stock-with-great-potential?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/mela">MELA</category>
      <category type="author" link="http://seekingalpha.com/author/paul-goodwin">Paul Goodwin</category>
    </item>
    <item>
      <title>Obama Takes Pressure Off Health Insurers</title>
      <link>http://seekingalpha.com/article/147369-obama-takes-pressure-off-health-insurers?source=feed</link>
      <guid isPermaLink="false">147369</guid>
      <content>
        <![CDATA[<p><span>The Obama administration Monday backed down from its demand that Congress enact a public option health plan and said that any approach that would increase competition among health insurers would be acceptable to the president.</span></p><p>Good move. If Congress takes the bait, health insurers will face uncertainty instead of extinction.</p>]]>
      </content>
      <pubDate>Tue, 07 Jul 2009 08:30:31 -0400</pubDate>
      <author>Donald Johnson</author>
      <description>
        <![CDATA[<strong><a href='http://www.businessword.com/'>Donald Johnson</a> submits:</strong><p><span>The Obama administration Monday backed down from its demand that Congress enact a public option health plan and said that any approach that would increase competition among health insurers would be acceptable to the president.</span></p><p>Good move. If Congress takes the bait, health insurers will face uncertainty instead of extinction.</p><br/><a href='http://seekingalpha.com/article/147369-obama-takes-pressure-off-health-insurers?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/aet">AET</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/ci">CI</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/cvh">CVH</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/hs">HS</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/hum">HUM</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/unh">UNH</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/vht">VHT</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/wlp">WLP</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/xlv">XLV</category>
      <category type="author" link="http://seekingalpha.com/author/donald-johnson">Donald Johnson</category>
    </item>
    <item>
      <title>Big Pharma:  Where's the Risk Management?</title>
      <link>http://seekingalpha.com/article/147364-big-pharma-where-s-the-risk-management?source=feed</link>
      <guid isPermaLink="false">147364</guid>
      <content>
        <![CDATA[<p>Novo Nordisk (<a href='http://seekingalpha.com/symbol/novo' title='More opinion and analysis of NOVO'>NOVO</a>) wrote down $280 million for its investment in inhaled insulin in January of 2008, but this is dwarfed by Pfizer&rsquo;s (<a href='http://seekingalpha.com/symbol/pfe' title='More opinion and analysis of PFE'>PFE</a>) write off in November of 2007 of $2.8 billion for its investment in Exubera, its entry into the inhaled insulin market. By March of 2008, Lilly (<a href='http://seekingalpha.com/symbol/lly' title='More opinion and analysis of LLY'>LLY</a>) also gave up the ghost, and wrote down its efforts in the area.</p>  <div> </div> <div><p>Interestingly, in 2000 Lilly had taken shown an interest in insulin taken in through the buccal tissues inside the cheek with a $1 million investment in Generex (<a href='http://seekingalpha.com/symbol/gnbt' title='More opinion and analysis of GNBT'>GNBT</a>). More about this delivery system later.</p></div>]]>
      </content>
      <pubDate>Tue, 07 Jul 2009 08:20:59 -0400</pubDate>
      <author>Thomas Barnard</author>
      <description>
        <![CDATA[<strong><a href='http://www.barnardobserver.com/'>Thomas Barnard</a> submits:</strong><p>Novo Nordisk (<a href='http://seekingalpha.com/symbol/novo' title='More opinion and analysis of NOVO'>NOVO</a>) wrote down $280 million for its investment in inhaled insulin in January of 2008, but this is dwarfed by Pfizer&rsquo;s (<a href='http://seekingalpha.com/symbol/pfe' title='More opinion and analysis of PFE'>PFE</a>) write off in November of 2007 of $2.8 billion for its investment in Exubera, its entry into the inhaled insulin market. By March of 2008, Lilly (<a href='http://seekingalpha.com/symbol/lly' title='More opinion and analysis of LLY'>LLY</a>) also gave up the ghost, and wrote down its efforts in the area.</p>  <div> </div> <div><p>Interestingly, in 2000 Lilly had taken shown an interest in insulin taken in through the buccal tissues inside the cheek with a $1 million investment in Generex (<a href='http://seekingalpha.com/symbol/gnbt' title='More opinion and analysis of GNBT'>GNBT</a>). More about this delivery system later.</p></div><br/><a href='http://seekingalpha.com/article/147364-big-pharma-where-s-the-risk-management?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/gnbt">GNBT</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/lly">LLY</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/nvo">NVO</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/pfe">PFE</category>
      <category type="author" link="http://seekingalpha.com/author/thomas-barnard">Thomas Barnard</category>
    </item>
    <item>
      <title>Good News for Sanofi-Aventis: Heart Drug Multaq Receives FDA Approval

</title>
      <link>http://seekingalpha.com/article/147357-good-news-for-sanofi-aventis-heart-drug-multaq-receives-fda-approval?source=feed</link>
      <guid isPermaLink="false">147357</guid>
      <content>
        <![CDATA[<p><strong>Sanofi-Aventis</strong> (<a href='http://seekingalpha.com/symbol/sny' title='More opinion and analysis of SNY'>SNY</a>) finally received some good news when the U.S. FDA approved the company&rsquo;s heart drug, Multaq, on July 2, 2009. Multaq provides patients suffering from atrial fibrillation &#40;AF&#41; or atrial flutter &#40;AFL&#41; with a new treatment option.<img src="http://static.seekingalpha.com/uploads/2009/7/7/saupload_sny.png" align="right" hspace="6" vspace="6" /><br><br>The approval process for Multaq was not exactly smooth sailing with the company receiving a non-approvable letter from the FDA for its initial new drug application &#40;NDA&#41; filing in 2006. Sanofi resubmitted its NDA in 2008 and received a favorable response from an FDA advisory panel in March 2009.</p>]]>
      </content>
      <pubDate>Tue, 07 Jul 2009 07:57:01 -0400</pubDate>
      <author>Zacks.com</author>
      <description>
        <![CDATA[<strong><a href="http://register.zacks.com/ucd/step1.php?ALERT=alpha&ADID=ALPHA_content_welcome">Zacks.com</a> submits: </strong>
<p><strong>Sanofi-Aventis</strong> (<a href='http://seekingalpha.com/symbol/sny' title='More opinion and analysis of SNY'>SNY</a>) finally received some good news when the U.S. FDA approved the company&rsquo;s heart drug, Multaq, on July 2, 2009. Multaq provides patients suffering from atrial fibrillation &#40;AF&#41; or atrial flutter &#40;AFL&#41; with a new treatment option.<img src="http://static.seekingalpha.com/uploads/2009/7/7/saupload_sny.png" align="right" hspace="6" vspace="6" /><br><br>The approval process for Multaq was not exactly smooth sailing with the company receiving a non-approvable letter from the FDA for its initial new drug application &#40;NDA&#41; filing in 2006. Sanofi resubmitted its NDA in 2008 and received a favorable response from an FDA advisory panel in March 2009.</p><br/><a href='http://seekingalpha.com/article/147357-good-news-for-sanofi-aventis-heart-drug-multaq-receives-fda-approval?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/sny">SNY</category>
      <category type="author" link="http://seekingalpha.com/author/zacks.com">Zacks.com</category>
    </item>
    <item>
      <title>FDA Calendar Updates: Oxford, Protalix, Spectrum, Shire</title>
      <link>http://seekingalpha.com/article/147285-fda-calendar-updates-oxford-protalix-spectrum-shire?source=feed</link>
      <guid isPermaLink="false">147285</guid>
      <content>
        <![CDATA[<p>Below is a summary of updates to the <a href="http://biomedreports.com/fda-calendar/fda-calendar.html"><font>BioMedReports.com FDA Calendar</font></a>, which includes a database of 240 entries as of 7/6/09. 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 <a href="http://www.biomedreports.com/"><font>BioMedReports.com</font></a>, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter <span>&#40;CRL&#41; re-submissions to the FDA, and pending late-stage clinical trial results.</span></p><div> </div><div>On 7/5/09, <b>Spectrum Pharma (NASDAQ:<a href='http://seekingalpha.com/symbol/sppi' title='More opinion and analysis of SPPI'>SPPI</a>) </b>announced that it has received a Complete Response Letter <span>&#40;CRL&#41; from the FDA for its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin&rsquo;s Lymphoma &#40;NHL&#41; patients. Zevalin is currently FDA approved and marketed by Spectrum for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.</span></div><div> </div><div>The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. SPPI highlighted the following regarding the CRL for Zevalin:  </div><ol><li>No additional clinical studies have been requested;</li><li>The additional data requested do not involve new data analyses; and </li><li>The Company plans to formally respond to the FDA&rsquo;s requests by 7/8/09.</li></ol><div> </div><div>CRL Resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) reviews by the FDA once they are officially accepted by the Agency. My expectation is for the FDA to formally accept Spectrum's resubmission within 1-2 weeks and classify it as a Class 1 review. The new 60-day review deadline is calculated from the resubmission date (i.e. no later than Weds. 7/8 according to SPPI).</div><div> </div><div>On 7/6/09, <b>Oxford BioMedica (<a href='http://seekingalpha.com/symbol/oxbdf.pk' title='More opinion and analysis of OXBDF.PK'>OXBDF.PK</a>)</b> announced that the FDA has approved the Company's plans to further develop its cancer vaccine candidate TroVax despite it missing a primary endpoint last year in a Phase 3 renal cancer trial. The FDA has invited submissions of adaptive Phase II/III trial designs in metastatic colorectal cancer being carried out by the Company's development partner <b>Sanofi-Aventis (NYSE:<a href='http://seekingalpha.com/symbol/sny' title='More opinion and analysis of SNY'>SNY</a>)</b>.</div><div> </div><div>On 7/6/09, <b>Protalix BioTherapeutics (AMEX:<a href='http://seekingalpha.com/symbol/plx' title='More opinion and analysis of PLX'>PLX</a>)</b> announced that it was approached by the FDA and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme, a mammalian cell expressed version of glucocerebrosidase &#40;GCD&#41; and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms.</div><div> </div><div>prGCD, the Company&rsquo;s lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase 3 clinical trial for the treatment of Gaucher disease. The FDA indicated to the Company that it believes the Company&rsquo;s development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol. PLX expects to submit a treatment protocol to the FDA for its review as a supplement to its current Investigational New Drug &#40;IND&#41; application for prGCD. PLX expects to report results of the Phase 3 trial during 2H09 and expects to submit a NDA for prGCD to the FDA and other global regulatory agencies during 4Q09.</div><div> </div><div>On 7/6/09, <b>Shire (NASDAQ:<a href='http://seekingalpha.com/symbol/shpgy' title='More opinion and analysis of SHPGY'>SHPGY</a>)</b> announced that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher Disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher Disease. If approved by the FDA, the treatment protocol would allow physicians to treat Gaucher Disease patients with velaglucerase alfa ahead of commercial availability in the U.S.</div><div> </div><div>Under the conditions of the treatment protocol, Shire would provide velaglucerase alfa free of charge initially, in order to provide access to patients as quickly as possible. Velaglucerase alfa is made with Shire's proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and carries a human glycosylation pattern. Shire is working with the FDA to file a NDA for velaglucerase alfa as soon as possible.</div><div> </div><div><em><strong>Disclosure: No positions.</strong></em></div>]]>
      </content>
      <pubDate>Tue, 07 Jul 2009 04:17:41 -0400</pubDate>
      <author>Mike Havrilla</author>
      <description>
        <![CDATA[<strong><a href='http://www.ETFinnovators.com'>Mike Havrilla</a> submits:</strong><p>Below is a summary of updates to the <a href="http://biomedreports.com/fda-calendar/fda-calendar.html"><font>BioMedReports.com FDA Calendar</font></a>, which includes a database of 240 entries as of 7/6/09. 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 <a href="http://www.biomedreports.com/"><font>BioMedReports.com</font></a>, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter <span>&#40;CRL&#41; re-submissions to the FDA, and pending late-stage clinical trial results.</span></p><div> </div><div>On 7/5/09, <b>Spectrum Pharma (NASDAQ:<a href='http://seekingalpha.com/symbol/sppi' title='More opinion and analysis of SPPI'>SPPI</a>) </b>announced that it has received a Complete Response Letter <span>&#40;CRL&#41; from the FDA for its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin&rsquo;s Lymphoma &#40;NHL&#41; patients. Zevalin is currently FDA approved and marketed by Spectrum for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.</span></div><div> </div><div>The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. SPPI highlighted the following regarding the CRL for Zevalin:  </div><ol><li>No additional clinical studies have been requested;</li><li>The additional data requested do not involve new data analyses; and </li><li>The Company plans to formally respond to the FDA&rsquo;s requests by 7/8/09.</li></ol><div> </div><div>CRL Resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) reviews by the FDA once they are officially accepted by the Agency. My expectation is for the FDA to formally accept Spectrum's resubmission within 1-2 weeks and classify it as a Class 1 review. The new 60-day review deadline is calculated from the resubmission date (i.e. no later than Weds. 7/8 according to SPPI).</div><div> </div><div>On 7/6/09, <b>Oxford BioMedica (<a href='http://seekingalpha.com/symbol/oxbdf.pk' title='More opinion and analysis of OXBDF.PK'>OXBDF.PK</a>)</b> announced that the FDA has approved the Company's plans to further develop its cancer vaccine candidate TroVax despite it missing a primary endpoint last year in a Phase 3 renal cancer trial. The FDA has invited submissions of adaptive Phase II/III trial designs in metastatic colorectal cancer being carried out by the Company's development partner <b>Sanofi-Aventis (NYSE:<a href='http://seekingalpha.com/symbol/sny' title='More opinion and analysis of SNY'>SNY</a>)</b>.</div><div> </div><div>On 7/6/09, <b>Protalix BioTherapeutics (AMEX:<a href='http://seekingalpha.com/symbol/plx' title='More opinion and analysis of PLX'>PLX</a>)</b> announced that it was approached by the FDA and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme, a mammalian cell expressed version of glucocerebrosidase &#40;GCD&#41; and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms.</div><div> </div><div>prGCD, the Company&rsquo;s lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase 3 clinical trial for the treatment of Gaucher disease. The FDA indicated to the Company that it believes the Company&rsquo;s development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol. PLX expects to submit a treatment protocol to the FDA for its review as a supplement to its current Investigational New Drug &#40;IND&#41; application for prGCD. PLX expects to report results of the Phase 3 trial during 2H09 and expects to submit a NDA for prGCD to the FDA and other global regulatory agencies during 4Q09.</div><div> </div><div>On 7/6/09, <b>Shire (NASDAQ:<a href='http://seekingalpha.com/symbol/shpgy' title='More opinion and analysis of SHPGY'>SHPGY</a>)</b> announced that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher Disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher Disease. If approved by the FDA, the treatment protocol would allow physicians to treat Gaucher Disease patients with velaglucerase alfa ahead of commercial availability in the U.S.</div><div> </div><div>Under the conditions of the treatment protocol, Shire would provide velaglucerase alfa free of charge initially, in order to provide access to patients as quickly as possible. Velaglucerase alfa is made with Shire's proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and carries a human glycosylation pattern. Shire is working with the FDA to file a NDA for velaglucerase alfa as soon as possible.</div><div> </div><div><em><strong>Disclosure: No positions.</strong></em></div><br/><a href='http://seekingalpha.com/article/147285-fda-calendar-updates-oxford-protalix-spectrum-shire?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/oxbdf.pk">OXBDF.PK</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/plx">PLX</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/shpgy">SHPGY</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/sppi">SPPI</category>
      <category type="author" link="http://seekingalpha.com/author/mike-havrilla">Mike Havrilla</category>
    </item>
    <item>
      <title>Obama's Health Care Reform Inspires Little Confidence </title>
      <link>http://seekingalpha.com/article/147269-obama-s-health-care-reform-inspires-little-confidence?source=feed</link>
      <guid isPermaLink="false">147269</guid>
      <content>
        <![CDATA[<p>America&rsquo;s health care system is broken, but President Obama inspires little confidence with his fix.</p><p>Health care absorbs 18 percent of GDP&mdash;about 50 percent more than in other wealthy countries. Prices are too high and are a terrible burden on jobs creation.</p>]]>
      </content>
      <pubDate>Tue, 07 Jul 2009 03:16:35 -0400</pubDate>
      <author>Peter Morici</author>
      <description>
        <![CDATA[<strong><a href="http://www.smith.umd.edu/faculty/pmorici/cv_pmorici.htm">Peter Morici</a> submits:</strong><p>America&rsquo;s health care system is broken, but President Obama inspires little confidence with his fix.</p><p>Health care absorbs 18 percent of GDP&mdash;about 50 percent more than in other wealthy countries. Prices are too high and are a terrible burden on jobs creation.</p><br/><a href='http://seekingalpha.com/article/147269-obama-s-health-care-reform-inspires-little-confidence?source=feed'>Complete Story &raquo;</a>]]>
      </description>
      <category type="symbol" link="http://seekingalpha.com/symbol/ixj">IXJ</category>
      <category type="symbol" link="http://seekingalpha.com/symbol/xlv">XLV</category>
      <category type="author" link="http://seekingalpha.com/author/peter-morici">Peter Morici</category>
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