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 <title>Anesiva</title>
 <link>http://www.fiercebiotech.com/tags/anesiva-0</link>
 <description></description>
 <language>en</language>
<item>
 <title>Anesiva drops Zingo, cuts jobs</title>
 <link>http://www.fiercebiotech.com/story/anesiva-drops-zingo-cuts-jobs/2008-11-11?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;p&gt;South San Francisco-based Anesiva released a host of announcements today. First, the company said that a Phase II trial of Adlea narrowly missed the primary endpoint of reducing post-surgical pain following bunionectomy surgery. However, the&amp;nbsp;trial achieved a key secondary endpoint of reducing opioid use for Adlea versus placebo over the four to 32 hour period. Anesiva will announce results from a second&amp;nbsp;Phase&amp;nbsp;III trial of the drug&amp;nbsp;next month.&lt;/p&gt;
&lt;p&gt;The company also said today that it would no longer make its transdermal pain patch Zingo. Anesiva cited &quot;continued manufacturing challenges and the need to recall product in the field due to a potential non-safety related shelf life issue from a lot of unreleased product&quot; as the reason for the decision. Fifteen jobs will be cut as Anesiva works to pay back a $20 million loan.&lt;/p&gt;
&lt;p&gt;This is Anesiva&#039;s second round of cuts. In September, the company axed&amp;nbsp;its preclinical development program as well as other &quot;non-core positions&quot; and reduced its head count by 20 percent.&lt;/p&gt;
&lt;p&gt;- see &lt;a href=&quot;http://www.fiercebiotech.com/press-releases/anesiva-announces-adlea-active-1-phase-3-clinical-results&quot;&gt;Anesiva&#039;s release&lt;/a&gt;&lt;br /&gt;- read the &lt;a href=&quot;http://www.bizjournals.com/sanjose/stories/2008/11/10/daily24.html?jst=b_ln_hl&quot;&gt;article&lt;/a&gt;&amp;nbsp;for more&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Related Articles:&lt;br /&gt;&lt;/strong&gt;&lt;a href=&quot;http://www.fiercebiotech.com/story/anesiva-axes-staff-preclinical-work-restructuring/2008-09-03&quot;&gt;Anesiva axes staff, preclinical work in restructuring&lt;/a&gt;&lt;br /&gt;&lt;a href=&quot;http://www.fiercebiotech.com/story/spotlight-anesiva-inks-114m-licensing-deal/2008-06-05?utm_medium=rss&amp;amp;utm_source=rss&amp;amp;cmp-id=OTC-RSS-FB0&quot;&gt;Anesiva inks $114M licensing deal&lt;/a&gt;&lt;/p&gt;</description>
 <comments>http://www.fiercebiotech.com/story/anesiva-drops-zingo-cuts-jobs/2008-11-11#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/adlea">Adlea</category>
 <category domain="http://www.fiercebiotech.com/tags/anesiva-0">Anesiva</category>
 <category domain="http://www.fiercebiotech.com/tags/layoffs">layoffs</category>
 <pubDate>Tue, 11 Nov 2008 10:00:24 -0500</pubDate>
 <dc:creator>Maureen Martino</dc:creator>
 <guid isPermaLink="false">41014 at http://www.fiercebiotech.com</guid>
</item>
<item>
 <title>Anesiva axes staff, preclinical work in restructuring</title>
 <link>http://www.fiercebiotech.com/story/anesiva-axes-staff-preclinical-work-restructuring/2008-09-03?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;p&gt;Anesiva is axing its preclinical development program as well as other &quot;non-core positions&quot; and reducing its head count by 20 percent as it restructures to focus on late-stage products and sales as the company makes its transition to a specialty pain management company. The South San Francisco biotech is also announced that it completed enrollment in two Phase III Adlea trials. Top-line data is expected in the fourth quarter.&lt;/p&gt;
&lt;p&gt;&quot;Since joining Anesiva in mid-June, I have conducted an extensive review of our programs, priorities and core competencies, which confirms my confidence in the underlying strength of our assets--namely our people and pipeline,&quot; said Michael L. Kranda, president and CEO. &quot;Based on this review we are refining our strategy and restructuring operations to drive the company toward long-term success.&quot;&lt;/p&gt;
&lt;p&gt;- check out &lt;a href=&quot;http://www.fiercebiotech.com/press-releases/anesiva-accelerates-its-transition-specialty-pharma-pain-management-company&quot;&gt;Anesiva&#039;s release&lt;/a&gt;&lt;br /&gt;- read the &lt;a href=&quot;http://www.streetinsider.com/Corporate+News/Anesiva+(ANSV)+to+Restructure+Operations+In+Order+to+Focus+on+Specialty+Pharma+Pain+Management%3B+Will+Cut+20%25+of+Workforce/3958090.html &quot;&gt;report&lt;/a&gt; from &lt;em&gt;StreetInsider&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Related Articles:&lt;br /&gt;&lt;/strong&gt;&lt;a href=&quot;http://www.fiercebiotech.com/story/spotlight-anesiva-inks-114m-licensing-deal/2008-06-05?utm_medium=rss&amp;amp;utm_source=rss&amp;amp;cmp-id=OTC-RSS-FB0&quot;&gt;Anesiva inks $114M licensing deal&lt;/a&gt;&lt;/p&gt;</description>
 <comments>http://www.fiercebiotech.com/story/anesiva-axes-staff-preclinical-work-restructuring/2008-09-03#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/adlea">Adlea</category>
 <category domain="http://www.fiercebiotech.com/tags/anesiva-0">Anesiva</category>
 <category domain="http://www.fiercebiotech.com/tags/layoffs">layoffs</category>
 <category domain="http://www.fiercebiotech.com/tags/restructuring">restructuring</category>
 <pubDate>Wed, 03 Sep 2008 11:08:16 -0400</pubDate>
 <dc:creator>John Carroll</dc:creator>
 <guid isPermaLink="false">34468 at http://www.fiercebiotech.com</guid>
</item>
<item>
 <title>SPOTLIGHT:  Anesiva inks $114M licensing deal</title>
 <link>http://www.fiercebiotech.com/story/spotlight-anesiva-inks-114m-licensing-deal/2008-06-05?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>
&lt;P&gt;Transcription Factor Therapeutics has licensed the worldwide rights to Anesiva&#039;s NF-kB Decoy program, which includes the clinical drug candidate Avrina. NF-kB Transcription Factor Decoy inhibits NF-kappa B, a protein implicated in the inflammatory cascade in diseases such as inflammatory bowel disease (IBD), eczema, rheumatoid arthritis, and asthma. Anesiva gets an upfront fee and up to $114 million in milestone payments if two products are developed. &lt;A href=&quot;http://www.fiercebiotech.com/press-releases/anesiva-and-transcription-factor-therapeutics-inc-announce-licensing-agreement-deve-0&quot;&gt;Release&lt;/a&gt;&lt;/p&gt;

</description>
 <comments>http://www.fiercebiotech.com/story/spotlight-anesiva-inks-114m-licensing-deal/2008-06-05#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/anesiva-0">Anesiva</category>
 <category domain="http://www.fiercebiotech.com/tags/arthritis-0">arthritis</category>
 <category domain="http://www.fiercebiotech.com/tags/asthma">asthma</category>
 <category domain="http://www.fiercebiotech.com/tags/drug-candidates">drug candidates</category>
 <category domain="http://www.fiercebiotech.com/tags/milestones">milestones</category>
 <category domain="http://www.fiercebiotech.com/tags/protein">protein</category>
 <category domain="http://www.fiercebiotech.com/tags/rheumatoid-arthritis">Rheumatoid Arthritis</category>
 <pubDate>Thu, 05 Jun 2008 06:59:53 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">27867 at http://www.fiercebiotech.com</guid>
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<item>
 <title>ALSO NOTED:  Zingo data lifts Anesiva stock; Two chemo drugs win approvals; BrainStorm plans trials; and much more...</title>
 <link>http://www.fiercebiotech.com/story/also-noted-zingo-data-lifts-anesiva-stock-two-chemo-drugs-win-approvals-brainstorm-plans-trial?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>
&lt;P&gt;&amp;gt; Shares of Anesiva jumped after the company announced positive top-line data from a late-stage study of Zingo, its drug candidate for reducing venous procedural pain. &lt;A href=&quot;http://www.fiercebiotech.com/press-releases/press-release-anesiva-announces-pivotal-phase-3-trial-zingo-meets-primary-endpoint&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; Bristol-Myers Squibb has won the FDA&#039;s approval for the chemo drug Ixempra for breast cancer. &lt;A href=&quot;http://www.fiercepharma.com/story/bms-cancer-med-could-earn-500m/2007-10-17&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; The FDA has approved Abraxis Pharmaceutical&#039;s chemotherapy drug Epirubicin hydrochloride injection in four dosage forms. &lt;A href=&quot;http://www.fiercebiotech.com/press-releases/press-release-abraxis-pharmaceutical-products-receives-fda-approval-epirubicin-hcl-in&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; Israel&#039;s BrainStorm Cell Therapeutics says it&#039;s likely to do clinical trials of its adult stem cell therapies in New York City. &lt;A href=&quot;http://www.nysun.com/article/64724&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; Sorry, &lt;FONT color=#000000&gt;&lt;A href=&quot;http://www.fiercebiotech.com/special-reports/5-amgen&quot;&gt;Amgen&lt;/a&gt;&lt;/font&gt; and &lt;FONT color=#000000&gt;&lt;A href=&quot;http://www.fiercebiotech.com/special-reports/4-johnson-johnson&quot;&gt;Johnson &amp;amp; Johnson&lt;/a&gt;&lt;/font&gt;. So says the FDA, which is backing up &lt;FONT color=#000000&gt;&lt;A href=&quot;http://www.fiercebiotech.com/press-releases/press-release-medicares-coverage-determination-epogen-consistent-labeling-and-publish&quot;&gt;Medicare&#039;s new limits&lt;/a&gt;&lt;/font&gt; on using the companies&#039; anemia drugs Aranesp, Epogen, and Procrit. &lt;A href=&quot;http://www.fiercepharma.com/story/fda-backs-medicares-anemia-drug-limits/2007-10-17&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; You can&#039;t accuse pharma companies of failing to think ahead. They begin to forge links with future doctors before they even start med school. &lt;A href=&quot;http://www.fiercepharma.com/story/med-schools-tight-drug-makers/2007-10-17&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&lt;STRONG&gt;And Finally... &lt;/strong&gt;In what is likely to provide a big push for antibiotic developers, a new study by the CDC shows that almost 19,000 Americans were killed by the MRSA superbug last year, making it more lethal than AIDS. &lt;A href=&quot;http://www.fiercebiotech.com/press-releases/press-release-cdc-estimates-94-000-invasive-drug-resistant-staph-infections-occurred-&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;

</description>
 <comments>http://www.fiercebiotech.com/story/also-noted-zingo-data-lifts-anesiva-stock-two-chemo-drugs-win-approvals-brainstorm-plans-trial#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/abraxis-pharmaceutical-0">Abraxis Pharmaceutical</category>
 <category domain="http://www.fiercebiotech.com/tags/amgen">Amgen</category>
 <category domain="http://www.fiercebiotech.com/tags/anesiva-0">Anesiva</category>
 <category domain="http://www.fiercebiotech.com/tags/aranesp-0">Aranesp</category>
 <category domain="http://www.fiercebiotech.com/tags/bristol-myers-squibb">Bristol-Myers Squibb</category>
 <category domain="http://www.fiercebiotech.com/tags/cell-therapeutics">Cell Therapeutics</category>
 <category domain="http://www.fiercebiotech.com/tags/drug-candidates">drug candidates</category>
 <category domain="http://www.fiercebiotech.com/tags/israel">Israel</category>
 <category domain="http://www.fiercebiotech.com/tags/pharma">pharmaceuticals</category>
 <category domain="http://www.fiercebiotech.com/tags/zingo-0">Zingo</category>
 <pubDate>Wed, 17 Oct 2007 06:59:50 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">9264 at http://www.fiercebiotech.com</guid>
</item>
<item>
 <title>ALSO NOTED:  Vernalis reports &quot;striking&quot; weight loss in trial; Genmab shares surge on Phase III; FDA wants more time on Entereg;</title>
 <link>http://www.fiercebiotech.com/story/also-noted-vernalis-reports-striking-weight-loss-trial-genmab-shares-surge-phase-iii-fda-wants?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;p&gt;
&amp;gt; Vernalis is reporting &amp;quot;striking&amp;quot; weight loss results in its Phase I trial of the obesity drug V24343. &lt;a href=&quot;http://www.fiercebiotech.com/press-releases/press-release-vernalis-announces-striking-weight-loss-phase-i-study-v24343-overweight&quot;&gt;Release&lt;/a&gt; 
&lt;/p&gt;
&lt;p&gt;
&amp;gt; Shares of Genmab surged today after the company reported that it&#039;s pushing HuMax-EGFr (zalutumumab) into Phase III for head and neck cancer. &lt;a href=&quot;http://www.fiercebiotech.com/press-releases/press-release-dahanca-initiates-head-and-neck-cancer-study-genmabs-humax-egfr&quot;&gt;Report&lt;/a&gt; 
&lt;/p&gt;
&lt;p&gt;
&amp;gt; Adolor says that the FDA wants more time to review submissions before it decides on whether it will lift a clinical hold on Entereg for postoperative ileus. &lt;a href=&quot;http://www.fiercebiotech.com/press-releases/press-release-adolor-corporation-says-fda-continues-clinical-hold-trial&quot;&gt;Report&lt;/a&gt;
&lt;/p&gt;
&lt;p&gt;
&amp;gt; A new study of the breast cancer drug tamoxifen demonstrates that it not only works against bipolar disease, it also works faster than many standard therapies. &lt;a href=&quot;http://www.washingtonpost.com/wp-dyn/content/article/2007/09/12/AR2007091201118.html&quot;&gt;Report&lt;/a&gt;
&lt;/p&gt;
&lt;p&gt;
&amp;gt; Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America announced that the first patient has been enrolled in a Phase III study of lubiprostone for opioid-induced bowel dysfunction. &lt;a href=&quot;http://www.fiercebiotech.com/press-releases/press-release-sucampo-pharmaceuticals-begins-pivotal-phase-iii-studies-oral-lubiprost&quot;&gt;Release&lt;/a&gt;
&lt;/p&gt;
&lt;p&gt;
&amp;gt; Anesiva has initiated a new Phase II study of Adlea for the relief of post-operative pain in patients undergoing total knee replacement surgery. &lt;a href=&quot;http://www.fiercebiotech.com/press-releases/press-release-anesiva-initiates-new-phase-2-trial-adlea&quot;&gt;Release&lt;/a&gt;
&lt;/p&gt;
&lt;p&gt;
&amp;gt; Trasylol got something of a reprieve yesterday when an FDA advisory panel recommended that it stay on the market. &lt;a href=&quot;http://www.fiercepharma.com/story/bayers-trasylol-stays-market/2007-09-13&quot;&gt;Report&lt;/a&gt;
&lt;/p&gt;
&lt;p&gt;
&amp;gt; When does good news feel almost bad? When a blockbuster drug is deemed the juiciest on the market--but the wolves are circling. If this sounds like Lipitor to you, you&#039;re right. &lt;a href=&quot;http://www.fiercepharma.com/story/lipitor-no-1-faces-generic-threat/2007-09-13&quot;&gt;Report&lt;/a&gt;
&lt;/p&gt;
&lt;p&gt;
&lt;strong&gt;And Finally… &lt;/strong&gt;A U.S. biotech company, Yorktown Technologies, is seeking regulatory permission to import and sell fish that have been genetically modified to glow. Researchers have been developing the fish to identify contaminated waters--though it looks like there could be quite a market among exotic fish lovers. &lt;a href=&quot;http://www.smh.com.au/news/National/GM-glowing-fish-could-be-sold/2007/09/12/1189276729046.html&quot;&gt;Report&lt;/a&gt;
&lt;/p&gt;
</description>
 <comments>http://www.fiercebiotech.com/story/also-noted-vernalis-reports-striking-weight-loss-trial-genmab-shares-surge-phase-iii-fda-wants#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/adolor">Adolor</category>
 <category domain="http://www.fiercebiotech.com/tags/anesiva-0">Anesiva</category>
 <category domain="http://www.fiercebiotech.com/tags/entereg-0">Entereg</category>
 <category domain="http://www.fiercebiotech.com/tags/genmab">GenMab</category>
 <category domain="http://www.fiercebiotech.com/tags/head-and-neck-cancer">head and neck cancer</category>
 <category domain="http://www.fiercebiotech.com/tags/obesity">obesity</category>
 <category domain="http://www.fiercebiotech.com/tags/phase-iii">Phase III</category>
 <category domain="http://www.fiercebiotech.com/tags/sucampo-0">Sucampo</category>
 <category domain="http://www.fiercebiotech.com/tags/vernalis-0">Vernalis</category>
 <pubDate>Thu, 13 Sep 2007 06:59:50 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">8584 at http://www.fiercebiotech.com</guid>
</item>
<item>
 <title>FDA approves Anesiva&#039;s needle-free pain drug</title>
 <link>http://www.fiercebiotech.com/story/fda-approves-anesivas-needle-free-pain-drug/2007-08-17?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;p&gt;
The FDA has given Anesiva a nod for Zingo, a single-use, needle-free system containing sterile lidocaine powder. Zingo provides rapid relief for pain associated with venous access procedures, such as intravenous insertions or the drawing of blood for tests. &amp;quot;Blood draws and IV insertions are the most frequently reported painful events in hospitalized children. Despite guidelines recommending the use of topical anesthetics prior to venous access procedures, currently available local anesthetics commonly take 20 minutes or longer to act, making their use in today&#039;s fast-paced hospital environment difficult. FDA approval of Zingo provides a unique option for healthcare providers who strive to safely and effectively manage children&#039;s pain during these procedures,&amp;quot; said John P. McLaughlin, CEO of Anesiva.
&lt;/p&gt;
&lt;p&gt;
Anesiva says that its needle-free delivery system may have broader applications, such as administration of insulin, human growth hormone, erythropoietin, calcitonin and other medications, excluding vaccines. Anesiva says it is open to licensing deals for the needle-free tech. 
&lt;/p&gt;
&lt;p&gt;
- see this &lt;a href=&quot;http://www.fiercebiotech.com/press-releases/press-release-anesiva-receives-fda-approval-zingo-product-reduce-pain-associated-need&quot;&gt;release&lt;/a&gt; for more
&lt;/p&gt;
&lt;p&gt;
&lt;strong&gt;Related Articles:&lt;br /&gt;
&lt;/strong&gt;Anesiva halts pain drug program after failure. &lt;a href=&quot;http://www.fiercebiotech.com/story/anesiva-halts-pain-drug-program-after-failure/2007-01-18&quot;&gt;Report&lt;/a&gt;&lt;br /&gt;
Analysts see a continuing surge of licensing deals. &lt;a href=&quot;http://www.fiercebiotech.com/story/analysts-see-a-continuing-surge-of-licensing-deals/2007-06-27&quot;&gt;Report&lt;/a&gt;
&lt;/p&gt;
</description>
 <comments>http://www.fiercebiotech.com/story/fda-approves-anesivas-needle-free-pain-drug/2007-08-17#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/anesiva-0">Anesiva</category>
 <category domain="http://www.fiercebiotech.com/tags/final-approval">FDA approval</category>
 <category domain="http://www.fiercebiotech.com/tags/fda-news">FDA update</category>
 <category domain="http://www.fiercebiotech.com/tags/human-growth-hormone">human growth hormone</category>
 <category domain="http://www.fiercebiotech.com/tags/insulin">insulin</category>
 <category domain="http://www.fiercebiotech.com/tags/zingo-0">Zingo</category>
 <pubDate>Fri, 17 Aug 2007 06:59:58 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">8165 at http://www.fiercebiotech.com</guid>
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