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 <title>1D00C3</title>
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 <title>FDA delay forces cutbacks at GPC Biotech</title>
 <link>http://www.fiercebiotech.com/story/fda-delay-forces-cutbacks-gpc-biotech/2007-08-23?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;p&gt;
Struggling to overcome &lt;a href=&quot;http://www.fiercebiotech.com/story/gpc-yanks-fda-application-satraplatin/2007-07-30&quot;&gt;FDA hurdles&lt;/a&gt; for its cancer drug satraplatin, Germany&#039;s GPC Biotech says it will slash its staff by 15 percent and &lt;a href=&quot;http://www.fiercebiotech.com/story/spotlight-gpc-hit-high-r-d-costs/2007-08-08&quot;&gt;ratchet down research and development costs&lt;/a&gt;. An FDA advisory committee opted to delay approval until the company can deliver final data on patient survival, which GPC has estimated would take six months. To survive the delay, the biotech is handing out 46 pink slips among its 316 employees. GPC licensed satraplatin five years ago, agreeing to take on development and regulatory costs. As part of the restructuring, GPC says it will slow down--for a while anyway--its work on its 1D09C3 monoclonal antibody and cell cycle inhibitors.  
&lt;/p&gt;
&lt;p&gt;
As part of a planned succession, Dr. Martine George is succeeding Dr. Marcel Rozencweig as senior vice president of drug development and chief medical officer. Dr. Rozencweig will remain with the company in the new role of senior vice president, clinical science and drug evaluation. 
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&lt;p&gt;
- check out the &lt;a href=&quot;http://www.fiercebiotech.com/press-releases/press-release-gpc-biotech-announces-restructuring&quot;&gt;release&lt;/a&gt; 
&lt;/p&gt;
&lt;p&gt;
&lt;strong&gt;Related Articles:&lt;/strong&gt;&lt;br /&gt;
GPC yanks FDA application for satraplatin. &lt;a href=&quot;http://www.fiercebiotech.com/story/gpc-yanks-fda-application-satraplatin/2007-07-30&quot;&gt;Report&lt;/a&gt;&lt;br /&gt;
FDA questions satraplatin. &lt;a href=&quot;http://www.fiercebiotech.com/story/spotlight-fda-questions-satraplatin/2007-07-23&quot;&gt;Report&lt;/a&gt;&lt;br /&gt;
Shares surge as satraplatin succeeds in Phase III. &lt;a href=&quot;http://www.fiercebiotech.com/story/shares-surge-as-satraplatin-succeeds-in-phase-iii/2006-09-25&quot;&gt;Report&lt;/a&gt;&lt;br /&gt;
Pharmion signs $270M licensing deal for GPC&#039;s satraplatin. &lt;a href=&quot;http://www.fiercebiotech.com/story/pharmion-signs-270m-licensing-deal-for-gpc-s-satraplatin/2005-12-20&quot;&gt;Report&lt;/a&gt; 
&lt;/p&gt;
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 <comments>http://www.fiercebiotech.com/story/fda-delay-forces-cutbacks-gpc-biotech/2007-08-23#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/1d00c3">1D00C3</category>
 <category domain="http://www.fiercebiotech.com/tags/oncology-drug">cancer drug</category>
 <category domain="http://www.fiercebiotech.com/tags/medical-officer">chief medical officer</category>
 <category domain="http://www.fiercebiotech.com/tags/germany">darmstadt germany</category>
 <category domain="http://www.fiercebiotech.com/tags/development-costs">development costs</category>
 <category domain="http://www.fiercebiotech.com/tags/drug-development">Drug Development</category>
 <category domain="http://www.fiercebiotech.com/tags/fda-official">FDA</category>
 <category domain="http://www.fiercebiotech.com/tags/fda-regulation">FDA regulation</category>
 <category domain="http://www.fiercebiotech.com/tags/gpc-biotech">GPC Biotech</category>
 <category domain="http://www.fiercebiotech.com/tags/job-cuts">job cuts</category>
 <category domain="http://www.fiercebiotech.com/tags/monoclonal-antibody">monoclonal antibody</category>
 <category domain="http://www.fiercebiotech.com/tags/satraplatin">satraplatin</category>
 <pubDate>Thu, 23 Aug 2007 06:59:58 -0400</pubDate>
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