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 <title>Paclitaxel</title>
 <link>http://www.fiercebiotech.com/tags/paclitaxel</link>
 <description></description>
 <language>en</language>
<item>
 <title>Cephalon paying $10M in cancer tech deal</title>
 <link>http://www.fiercebiotech.com/story/cephalon-paying-10m-in-cancer-tech-deal/2008-03-31?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>
&lt;P&gt;Cephalon is paying out $10 million to acquire the IP rights to &lt;A href=&quot;http://www.fiercepharma.com/special-reports/acusphere-worst-pharma-stocks-2007&quot;&gt;Acusphere&#039;s &lt;/a&gt;Hydrophobic Drug Delivery System for oncology applications along with the rights to AI-850, the formulation of paclitaxel. &lt;/p&gt;
&lt;P&gt;&quot;We are very pleased with the terms of this transaction, which establishes a strong value for part of our technology platform that is at an early stage of development,&quot; said Sherri C. Oberg, president and CEO of Acusphere. &quot;We are confident that Cephalon is the right partner for one application of this important technology, given its strong focus on oncology. Just six months ago, we announced that AI-850 was a potential bio-equivalent to the one of the fast-growing anti-cancer drugs, Abraxane. This transaction confirms the potential for our technology in the oncology arena, which is one of many potential applications for our HDDS technology.&quot;&lt;/p&gt;
&lt;P&gt;- check out the &lt;A href=&quot;http://www.fiercebiotech.com/press-releases/acusphere-inc-acus-licenses-hydrophobic-drug-delivery-system-cephalon-10-million&quot;&gt;press release&lt;/a&gt;&amp;nbsp;for more info&lt;/p&gt;
&lt;P&gt;&lt;STRONG&gt;Related Articles:&lt;BR /&gt;&lt;/strong&gt;Cephalon pays CEO more than hefty rivals. &lt;A href=&quot;http://www.fiercepharma.com/story/cephalon-pays-ceo-more-than-hefty-rivals/2008-03-26?utm_medium=rss&amp;utm_source=rss&quot;&gt;Report&lt;/a&gt;&lt;BR /&gt;FTC sues Cephalon for blocking generics. &lt;A href=&quot;http://www.fiercepharma.com/story/ftc-sues-cephalon-for-blocking-generics/2008-02-14&quot;&gt;Report&lt;/a&gt;&lt;BR /&gt;Cephalon to pay $425M settlement. &lt;A href=&quot;http://www.fiercepharma.com/story/cephalon-pay-425m-settlement/2007-11-09&quot;&gt;Report&lt;/a&gt;&lt;BR /&gt;Cephalon takes heat for off-label narcotic promotion. &lt;A href=&quot;http://www.fiercebiotech.com/story/cephalon-takes-heat-for-off-label-narcotic-promotion/2006-11-21&quot;&gt;Report&lt;/a&gt;&lt;BR /&gt;Acusphere--Worst Pharma Stocks of 2007. &lt;A href=&quot;http://www.fiercepharma.com/special-reports/acusphere-worst-pharma-stocks-2007&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;

</description>
 <comments>http://www.fiercebiotech.com/story/cephalon-paying-10m-in-cancer-tech-deal/2008-03-31#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/cancer-drug">Cancer Drugs</category>
 <category domain="http://www.fiercebiotech.com/tags/ftc">ftc</category>
 <category domain="http://www.fiercebiotech.com/tags/oncology">Oncology</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <pubDate>Mon, 31 Mar 2008 07:59:54 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">21681 at http://www.fiercebiotech.com</guid>
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<item>
 <title>Avanti launches bionano company</title>
 <link>http://www.fiercebiotech.com/story/avanti-launches-bionano-company/2008-03-28?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>
&lt;P&gt;Avanti Therapeutics launched a new bionanotechnology company for targeted drug delivery called Chikujee Therapeutics. Chikujee will use Avanti&#039;s drug delivery technology to enhance the performance of drugs, specifically anti-cancer drugs. The first drug classes the company will focus on are taxols (Paclitaxel and Docetaxel) and camptothecin for chemotherapy. Chikujee is Avanti&#039;s third early-stage company.&lt;/p&gt;
&lt;P&gt;- here&#039;s the &lt;A href=&quot;http://www.fiercebiotech.com/press-releases/avanti-therapeutics-launches-chikujee-therapeutics-targeted-drug-delivery-company&quot;&gt;release&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&lt;STRONG&gt;Related Articles:&lt;BR /&gt;&lt;/strong&gt;Biotech says nano-device can directly target cancer cells. &lt;A href=&quot;http://www.fiercebioresearcher.com/story/biotech-says-nano-device-can-directly-target-cancer-cells/2007-05-15&quot;&gt;Report&lt;/a&gt;&lt;BR /&gt;MD considers funds for growing nano-biotech field. &lt;A href=&quot;http://www.fiercebiotech.com/story/md-considers-funds-for-growing-nano-biotech-field/2008-02-27&quot;&gt;Report&lt;/a&gt;&lt;BR /&gt;Venture capitalists bet big on nanotechnology. &lt;A href=&quot;http://www.fiercebiotech.com/story/venture-capitalists-bet-big-nanotechnology/2007-09-12&quot;&gt;Report&lt;/a&gt;&lt;BR /&gt;Nanotech is promising, but faces hurdles. &lt;A href=&quot;http://www.fiercebiotech.com/story/nanotech-promising-faces-hurdles/2007-09-21&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;

</description>
 <comments>http://www.fiercebiotech.com/story/avanti-launches-bionano-company/2008-03-28#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/cancer">Cancer</category>
 <category domain="http://www.fiercebiotech.com/tags/cancer-drug">Cancer Drugs</category>
 <category domain="http://www.fiercebiotech.com/tags/chemotherapy">chemotherapy</category>
 <category domain="http://www.fiercebiotech.com/tags/drug-delivery-technology">drug delivery technology</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/venture-capitalists">Venture Capital</category>
 <pubDate>Fri, 28 Mar 2008 07:59:54 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">21535 at http://www.fiercebiotech.com</guid>
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 <title>ALSO NOTED:  Phyton cuts staff; Alzheimer&#039;s: A new indication for Enbrel?; and much more...</title>
 <link>http://www.fiercebiotech.com/story/also-noted-phyton-cuts-staff-alzheimers-new-indication-enbrel-and-much-more/2008-01-10?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>
&lt;P&gt;&amp;gt; According to research released today, the anti-rheumatoid arthritis med Enbrel has shown an amazing ability to rehabilitate Alzheimer&#039;s patients. &lt;A href=&quot;http://www.fiercepharma.com/story/enbrel-jump-starts-alzheimers-patient/2008-01-10&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; Phyton Biotech, based in Princeton, NJ, is laying off 47 workers. Phyton manufactures the cancer drug paclitaxel. There&#039;s no word yet on what triggered the cuts. &lt;A href=&quot;http://www.nj.com/business/index.ssf/2008/01/princeton_biotech_cutting_jobs.html&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; Amarin says it will launch a mid-stage study of its age-associated memory impairment drug AMR101. &lt;A href=&quot;http://www.fiercebiotech.com/press-releases/amarin-commence-phase-ii-trial-amr101-age-associated-memory-impairment&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; The transplant drug sirolimus demonstrated efficacy against a rare lung condition and may be able to improve lung function as well, according to a new study. &lt;A href=&quot;http://www.fiercebiotech.com/press-releases/transplant-drug-sirolimus-shrinks-tumors-improves-lung-function&quot;&gt;Release&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; A new type of meningococcal vaccine proved effective in combating four strains of the disease in all age groups, leading Novartis researchers to believe that they may be onto the first such vaccine that can be made available to babies. &lt;A href=&quot;http://www.fiercebioresearcher.com/vaccines/story/novartis-meningitis-vaccine-delivers-positive-data/2008-01-10&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; A new study appears to fully sever the alleged link between the mercury-containing thimerosal and autism. &lt;A href=&quot;http://www.fiercebioresearcher.com/vaccines/story/study-rejects-thimerosal-cause-autism/2008-01-10&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;&amp;gt; As part of its &lt;A href=&quot;http://www.fiercepharma.com/story/nigeria-calls-pfizer-execs-trial/2007-10-03&quot;&gt;infamous prosecution of Pfizer&lt;/a&gt;, a Nigerian court has issued warrants for eight Pfizer officials. &lt;A href=&quot;http://www.fiercepharma.com/story/nigeria-arrests-pfizer-director/2008-01-10&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;
&lt;P&gt;
&lt;/p&gt;&lt;P&gt;&lt;STRONG&gt;And Finally... &lt;/strong&gt;A universal flu vaccine may be on the horizon. &lt;A href=&quot;http://www.fiercebioresearcher.com/vaccines/story/universal-flu-vaccine-shows-early-promise/2008-01-10&quot;&gt;Report&lt;/a&gt;&lt;/p&gt;

</description>
 <comments>http://www.fiercebiotech.com/story/also-noted-phyton-cuts-staff-alzheimers-new-indication-enbrel-and-much-more/2008-01-10#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/amarin-0">Amarin</category>
 <category domain="http://www.fiercebiotech.com/tags/oncology-drug">cancer drug</category>
 <category domain="http://www.fiercebiotech.com/tags/flu-vaccine">flu vaccine</category>
 <category domain="http://www.fiercebiotech.com/tags/novartis">Novartis</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/pfizer">Pfizer</category>
 <category domain="http://www.fiercebiotech.com/tags/rheumatoid-arthritis">Rheumatoid Arthritis</category>
 <pubDate>Thu, 10 Jan 2008 06:59:50 -0500</pubDate>
 <dc:creator />
 <guid isPermaLink="false">15122 at http://www.fiercebiotech.com</guid>
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<item>
 <title>Avastin re-submitted to FDA</title>
 <link>http://www.fiercebiotech.com/story/avastin-re-submitted-fda/2007-08-24?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;p&gt;
Perhaps the second time is the charm for Genentech. The biotech has re-submitted a sBLA to the FDA for Avastin in combination with paclitaxel chemotherapy as a first-line treatment for metastatic breast cancer. In September 2006 Genentech was dealt a setback when the FDA asked to see more data, including an independent review, before it would approve the new indication. Genentech supplied the additional information and the six-month FDA review process will now begin. 
&lt;/p&gt;
&lt;p&gt;
- here&#039;s the &lt;a href=&quot;http://www.fiercebiotech.com/press-releases/press-release-genentech-announces-resubmission-sbla-avastin-combination-paclitaxel&quot;&gt;release&lt;/a&gt; on the sBLA&lt;br /&gt;
- read this &lt;a href=&quot;http://www.forbes.com/markets/feeds/afx/2007/08/24/afx4051839.html&quot;&gt;article&lt;/a&gt; from &lt;em&gt;Forbes&lt;/em&gt; 
&lt;/p&gt;
&lt;p&gt;
&lt;strong&gt;ALSO: &lt;/strong&gt;Watch a blockbuster cancer drug become a behemoth: Roche has won European regulatory approval for treatment of advanced non-small cell lung cancer with Avastin. &lt;em&gt;&lt;a href=&quot;http://www.fiercepharma.com/story/avastin-wins-new-regulatory-approval/2007-08-24&quot;&gt;FiercePharma&lt;/a&gt;&lt;/em&gt; 
&lt;/p&gt;
&lt;p&gt;
&lt;strong&gt;Related Articles:&lt;/strong&gt;&lt;br /&gt;
Genentech touts pipeline prospects as doubts fester. &lt;a href=&quot;http://www.fiercebiotech.com/story/genentech-touts-pipeline-prospects-as-doubts-fester/2007-06-28?utm_source=related&amp;amp;utm_medium=internal&quot;&gt;Report&lt;/a&gt;&lt;br /&gt;
Genentech fights to keep edge in drug development. &lt;a href=&quot;http://www.fiercebiotech.com/story/genentech-fights-to-keep-edge-in-drug-development/2007-06-11&quot;&gt;Report&lt;/a&gt;&lt;br /&gt;
FDA deals setback to Genentech. &lt;a href=&quot;http://www.fiercebiotech.com/story/fda-deals-setback-to-genentech/2006-09-11&quot;&gt;Report&lt;/a&gt; 
&lt;/p&gt;
</description>
 <comments>http://www.fiercebiotech.com/story/avastin-re-submitted-fda/2007-08-24#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/avastin">Avastin</category>
 <category domain="http://www.fiercebiotech.com/tags/breast-cancer">breast cancer</category>
 <category domain="http://www.fiercebiotech.com/tags/oncology-drug">cancer drug</category>
 <category domain="http://www.fiercebiotech.com/tags/chemotherapy">chemotherapy</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/final-approval">FDA approval</category>
 <category domain="http://www.fiercebiotech.com/tags/genentech">Genentech</category>
 <category domain="http://www.fiercebiotech.com/tags/lung-cancer">lung cancer</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/officials">Regulators</category>
 <category domain="http://www.fiercebiotech.com/tags/roche">Roche</category>
 <category domain="http://www.fiercebiotech.com/tags/sbla">sBLA</category>
 <pubDate>Fri, 24 Aug 2007 06:59:58 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">8280 at http://www.fiercebiotech.com</guid>
</item>
<item>
 <title>Press Release: Phase III Trial of Nexavar Does Not Meet Primary Endpoint</title>
 <link>http://www.fiercebiotech.com/node/4789?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;p&gt;Phase III Trial of Nexavar in Patients with Advanced Melanoma Does Not Meet Primary Endpoint&lt;/p&gt;
&lt;p&gt;WEST HAVEN, Conn. and EMERYVILLE, Calif., Dec. 4 -- Bayer Pharmaceuticals Corporation (NYSE: BAY - News) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that a Phase III trial administering Nexavar® (sorafenib) or placebo tablets in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with advanced melanoma did not meet its primary endpoint of improving progression-free survival (PFS). The treatment effect was comparable in each arm. Data from the study will be presented at an upcoming scientific congress.&lt;/p&gt;
&lt;p&gt;&quot;We are disappointed, first and foremost, for the patients with refractory metastatic melanoma for whom treatment options are so limited,&quot; said Hollings C. Renton, Onyx&#039;s chairman, president, and chief executive officer. &quot;However, this trial does not change our commitment to, and belief in, Nexavar. We hope to demonstrate utility in a wide variety of tumors and we will continue to broaden our clinical program, including increasing our attention to the more common malignancies in which anti-angiogenics have demonstrated activity.&quot;&lt;/p&gt;
&lt;p&gt;Phase III Study Design&lt;/p&gt;
&lt;p&gt;The international Phase III, double-blind, randomized, placebo-controlled trial evaluated Nexavar when administered in combination with a standard dosing schedule (21-day cycles) of carboplatin and paclitaxel. Two hundred seventy patients progressing after one previous systemic chemotherapeutic treatment (with either dacarbazine (DTIC) or temozolomide) were enrolled into the study. The study was designed to measure the safety and efficacy of Nexavar when co-administered with chemotherapy, and had PFS as its primary endpoint. PFS is defined as the time that a patient lives without meaningful tumor growth. The safety profile of these agents in combination (Nexavar with carboplatin/paclitaxel) was comparable to those previously reported for these agents in combination.&lt;/p&gt;
&lt;p&gt;About Melanoma&lt;/p&gt;
&lt;p&gt;In the United States (U.S.), the incidence of melanoma has doubled in the last 25 years. Melanoma accounts for about four percent of skin cancer cases, but is responsible for approximately 77 percent of skin cancer deaths. In 2006, it is estimated that over 62,000 new cases of melanoma will be diagnosed in the U.S., with close to 8,000 people expected to die from the disease. Worldwide, it is estimated that about 132,000 people are diagnosed with melanoma and more than 40,000 die from the disease each year.&lt;/p&gt;
&lt;p&gt;About Nexavar&lt;/p&gt;
&lt;p&gt;Nexavar is an oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases included RAF kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, and FLT-3.&lt;/p&gt;
&lt;p&gt;Nexavar is currently approved in a number of countries, including the U.S. and the European Union, for the treatment of patients with advanced kidney cancer. In addition, Nexavar is being evaluated as a single agent in a Phase III clinical trial for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, a study that has completed enrollment. A Phase III clinical trial of Nexavar combined with carboplatin and paclitaxel in non- small cell lung cancer (NSCLC) for treatment-naive patients was initiated in the first half of 2006. In addition to company-sponsored trials, there are a number of Nexavar studies being sponsored by government agencies, cooperative groups, and individual investigators, including a Phase III trial evaluating Nexavar in the adjuvant treatment of RCC.&lt;/p&gt;
&lt;p&gt;Important Safety Considerations for U.S. Patients Taking Nexavar&lt;/p&gt;
&lt;p&gt;Based on the current, approved package insert for the treatment of patients with advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15 percent for Nexavar vs. 8 percent for placebo, and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9 percent for Nexavar vs. 0.4 percent for placebo. Gastrointestinal perforation was an uncommon event and has been reported in less than 1% of patients taking Nexavar. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia and nausea. Grade 3/4 adverse events were 38 percent for Nexavar vs. 28 percent for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.&lt;/p&gt;
&lt;p&gt;For U.S. Nexavar prescribing information, visit http://www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).&lt;/p&gt;
&lt;p&gt;About Onyx Pharmaceuticals, Inc.&lt;/p&gt;
&lt;p&gt;Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer. The company is developing Nexavar®, a small molecule drug, with Bayer Pharmaceuticals Corporation. Nexavar has been approved for the treatment of advanced kidney cancer. For more information about Onyx&#039;s pipeline and activities, visit the company&#039;s web site at: http://www.onyx-pharm.com.&lt;/p&gt;
&lt;p&gt;About Bayer Pharmaceuticals Corporation Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com) is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG. Bayer HealthCare is one of the world&#039;s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. Bayer HeathCare generated sales amounting to some 9.4 billion euros and employed 33,800 people worldwide in 2005.&lt;/p&gt;
&lt;p&gt;The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals divisions. The new Pharmaceuticals division was established on January 1, 2006, and comprises the former Biological Products and Pharmaceutical divisions. Bayer HealthCare Pharmaceuticals now has three business units: Hematology/Cardiology, Oncology and Primary Care.&lt;/p&gt;
&lt;p&gt;Bayer HealthCare&#039;s aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.&lt;/p&gt;
&lt;p&gt;Forward Looking Statements&lt;/p&gt;
&lt;p&gt;This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer&#039;s public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.&lt;/p&gt;
&lt;p&gt;This news release also contains &quot;forward-looking statements&quot; of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes, and commercialization efforts of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx&#039;s Annual Report on Form 10-K for the year ended December 31, 2005, filed with the Securities and Exchange Commission under the heading &quot;Risk Factors&quot; and Onyx&#039;s Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward- looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.&lt;/p&gt;
&lt;p&gt;Nexavar® (sorafenib) tablets is a registered trademark of Bayer Pharmaceuticals Corporation&lt;/p&gt;
</description>
 <comments>http://www.fiercebiotech.com/node/4789#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/combination">combination</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/phase-iii">Phase III</category>
 <pubDate>Sun, 03 Dec 2006 11:50:52 -0500</pubDate>
 <dc:creator>Maureen Martino</dc:creator>
 <guid isPermaLink="false">4789 at http://www.fiercebiotech.com</guid>
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<item>
 <title>SPOTLIGHT:  Synta gets fast track for cancer therapy</title>
 <link>http://www.fiercebiotech.com/story/spotlight-synta-gets-fast-track-for-cancer-therapy/2006-11-15?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;P&gt;&lt;BR&gt;The FDA has granted Synta Pharmaceuticals fast-track status for its lead oncology drug candidate, &lt;A href=&quot;http://www.fiercebiotech.com/story/spotlight-synta-trial-hits-endpoint/2006-09-15&quot;&gt;STA-4783&lt;/A&gt;. In a recently completed, Phase IIb clinical trial in patients with Stage IV metastatic malignant melanoma, treatment with STA-4783 plus paclitaxel achieved the primary endpoint of increasing progression-free survival. Synta was a 2004 &lt;A href=&quot;http://www.fiercebiotech.com/Fierce15/2004/#Synta&quot;&gt;Fierce 15&lt;/A&gt; company.&amp;nbsp;&lt;A href=&quot;http://www.fiercebiotech.com/story/press-release-synta-pharmaceuticals-gets-fda-fast-track-designation-for-sta/2006-11-14&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;

</description>
 <comments>http://www.fiercebiotech.com/story/spotlight-synta-gets-fast-track-for-cancer-therapy/2006-11-15#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/oncology-drug">cancer drug</category>
 <category domain="http://www.fiercebiotech.com/tags/fda-official">FDA</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/phase-ii">Phase II</category>
 <category domain="http://www.fiercebiotech.com/tags/synta-pharmaceuticals">Synta Pharmaceuticals</category>
 <pubDate>Tue, 14 Nov 2006 19:01:33 -0500</pubDate>
 <dc:creator />
 <guid isPermaLink="false">4600 at http://www.fiercebiotech.com</guid>
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 <title>Press Release: Synta Pharmaceuticals gets FDA Fast Track Designation for STA-4783</title>
 <link>http://www.fiercebiotech.com/story/press-release-synta-pharmaceuticals-gets-fda-fast-track-designation-for-sta/2006-11-14?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;p&gt;&lt;strong&gt;Synta Pharmaceuticals Announces FDA Fast Track Designation for STA-4783 in Metastatic Melanoma&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;-- Designation Follows Announcement of Positive Phase 2b Clinical Data for Novel Compound -- &lt;/p&gt;
&lt;p&gt;LEXINGTON, Mass.--(BUSINESS WIRE)--Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, announced today that its lead oncology drug candidate, STA-4783, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma, a serious type of skin cancer. In a recently completed, Phase 2b double-blind, randomized, controlled clinical trial in patients with Stage IV metastatic malignant melanoma, treatment with STA-4783 plus paclitaxel achieved the primary endpoint of increasing progression-free survival. &lt;/p&gt;
&lt;p&gt;“We are very pleased to have received Fast Track designation for STA-4783. This is an important milestone for the program that will help the development and regulatory process,” said Safi Bahcall, President and Chief Executive Officer of Synta. “Metastatic melanoma is a disease with very limited treatment options for patients and a high mortality rate. We look forward to a productive collaboration with the FDA as we seek to realize the potential of STA-4783 to benefit these patients.” &lt;/p&gt;
&lt;p&gt;The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drug candidates that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs. Fast Track designation allows a company to file a New Drug Application (NDA) on a rolling basis as data become available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. Fast Track designation may facilitate more frequent interactions with the FDA and may lead to a priority review, which could decrease the typical review period. However, Fast Track designation has no impact on the standard of review or on whether the FDA ultimately approves the drug for marketing. &lt;/p&gt;
&lt;p&gt;About STA-4783 &lt;/p&gt;
&lt;p&gt;STA-4783 is an investigational, novel, small molecule drug candidate that induces a stress response in a wide variety of cancer cell types. This stress response results in two changes that may be important to the role of STA-4783 in tumor cell killing in combination with taxanes: a dramatic increase in the production of Hsp70 and other heat shock and stress-related proteins, which can enhance immune-mediated killing of tumor cells, and the alteration of certain signal transduction pathways in tumor cells, which can affect cell proliferation and induce programmed cell death, or apoptosis. In preclinical studies, STA-4783 combined with taxanes has shown activity against a broad range of cancers, including breast, lung, colon, lymphomas, and melanoma. To date, STA-4783 has been administered to a total of approximately 300 patients across multiple studies. &lt;/p&gt;
&lt;p&gt;STA-4783 was tested in a Phase 2b double-blind, randomized, controlled clinical trial in patients with Stage IV metastatic melanoma at 21 clinical sites in the United States. A total of 81 patients were enrolled in this trial, which compared the effects of treatment with STA-4783 plus paclitaxel to treatment with paclitaxel alone. The primary endpoint of this trial was progression-free survival, which is the time from randomization until death or objective tumor progression, as defined by the industry standard RECIST criteria (Response Evaluation Criteria in Solid Tumors). In the intent-to-treat analysis, which includes all 81 patients, treatment improved the median progression-free survival from 1.84 months for patients receiving paclitaxel alone to 3.68 months for those receiving paclitaxel plus STA-4783 (p=0.035). In this analysis, the hazard ratio, an estimate of the risk of progression in the combination arm relative to the control arm, was 0.50. In the per-protocol analysis, which includes the 77 patients who were evaluable for efficacy as specified in the protocol, treatment improved progression-free survival from 1.84 months for paclitaxel alone to 4.40 months for paclitaxel plus STA-4783 (p=0.017). The hazard ratio in this analysis was 0.42. &lt;/p&gt;
&lt;p&gt;STA-4783 was generally well tolerated in this study; adverse events were typical of those expected for paclitaxel alone. The most common adverse events in the STA-4783 plus paclitaxel group included fatigue, alopecia, constipation, nausea, hypoaesthesia, arthralgia, insomnia, diarrhea, and anemia. Certain adverse events including hypoaesthesia, neutropenia, stomatitis, arthralgia, and fatigue – all expected from paclitaxel treatment alone – occurred with higher incidence in the STA-4783 plus paclitaxel group, which may be partially attributable to the longer duration of paclitaxel treatment in this study group due to longer progression-free survival. The incidences of adverse events (including Grade 3 and above) were generally comparable between the two groups. &lt;/p&gt;
&lt;p&gt;About Metastatic Melanoma &lt;/p&gt;
&lt;p&gt;Melanoma, the most deadly form of skin cancer, arises from melanocytes, the pigment-producing cells of the skin. According to the American Cancer Society, melanoma accounts for approximately five percent of all skin cancers but causes about 75% of all skin cancer-related deaths. An estimated 60,000 people will be diagnosed and nearly 8,000 people will die from melanoma this year in the U.S. alone. If diagnosed and surgically removed while localized in the outermost skin layer, melanoma is potentially curable; however, for patients with deeper lesions or metastatic disease, the prognosis is poor, with limited available treatments and an expected survival of only six to nine months. The incidence of melanoma has increased more rapidly than any other cancer during the past ten years. The FDA has not approved a novel, small molecule drug for the treatment of metastatic melanoma in over 30 years. &lt;/p&gt;
&lt;p&gt;About Synta Pharmaceuticals &lt;/p&gt;
&lt;p&gt;Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases. Synta has a unique chemical compound library, an integrated discovery engine, and a diverse pipeline of clinical- and preclinical-stage drug candidates with distinct mechanisms of action and novel chemical structures. All Synta drug candidates were discovered and developed internally. For more information, please see www.syntapharma.com&lt;/p&gt;
</description>
 <comments>http://www.fiercebiotech.com/story/press-release-synta-pharmaceuticals-gets-fda-fast-track-designation-for-sta/2006-11-14#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/biopharmaceutical-company">biopharmaceutical company</category>
 <category domain="http://www.fiercebiotech.com/tags/oncology-drug">cancer drug</category>
 <category domain="http://www.fiercebiotech.com/tags/drug-candidates">drug candidates</category>
 <category domain="http://www.fiercebiotech.com/tags/track-designation">Fast Track designation</category>
 <category domain="http://www.fiercebiotech.com/tags/fda-official">FDA</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/phase-ii">Phase II</category>
 <category domain="http://www.fiercebiotech.com/tags/skin-cancer">skin cancer</category>
 <category domain="http://www.fiercebiotech.com/tags/synta-pharmaceuticals">Synta Pharmaceuticals</category>
 <pubDate>Tue, 14 Nov 2006 11:48:22 -0500</pubDate>
 <dc:creator>Maureen Martino</dc:creator>
 <guid isPermaLink="false">4597 at http://www.fiercebiotech.com</guid>
</item>
<item>
 <title>Editor&#039;s Corner</title>
 <link>http://www.fiercebiotech.com/story/editor-s-corner/2006-10-17?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;P&gt;&lt;IMG height=29 src=&quot;http://static.fiercemarkets.com/public/newsletter/assets/editors_corner_small.gif&quot; width=136 border=0&gt;&lt;IMG height=149 src=&quot;http://static.fiercemarkets.com/public/newsletter/fiercebiotech/john_headshot.gif&quot; width=99 align=right border=0&gt;&lt;BR&gt;Several comments came in about yesterday&#039;s &lt;A href=&quot;http://www.fiercebiotech.com/story/editor-s-corner/2006-10-16&quot;&gt;editor&#039;s note&lt;/A&gt; on the need for price caps on some of the new and more expensive therapies hitting the market. Seattle-based Gail E. Gillenwater, PhD, from Pharma Development Solutions, had these thoughts:&lt;/P&gt;
&lt;P&gt;&quot;Your comments in today&#039;s &lt;EM&gt;FierceBiotech&#039;s&lt;/EM&gt; post regarding current pricing practices for new drug products were, as usual, on target. One additional important point regarding Avastin therapy is that the actual cost to patients/third-party payers is not the $55,000 to $100,000 that will be charged. Rather, the actual drug costs to patients using Avastin is the cost of Avastin plus carboplatin and paclitaxel, since the safety and efficacy of Avastin was studied and approved only as combination therapy.&lt;/P&gt;
&lt;P&gt;Also, note that Avastin, an anti-VEGF agent, is associated with significant side effects, which also will increase the actual cost of using this therapy.&lt;/P&gt;
&lt;P&gt;Development of drugs such as Avastin that have new mechanisms of action allowing a multi-factorial approach to treating cancer are important therapeutic advances, and it&#039;s important to understand and appreciate the actual costs and limitations of these therapies.&quot; - &lt;A href=&quot;mailto:john@fiercebiotech.com&quot;&gt;John Carroll&lt;/A&gt;&lt;/P&gt;

</description>
 <comments>http://www.fiercebiotech.com/story/editor-s-corner/2006-10-17#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/avastin">Avastin</category>
 <category domain="http://www.fiercebiotech.com/tags/combination">combination</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/pharma">pharmaceuticals</category>
 <pubDate>Mon, 16 Oct 2006 20:01:39 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">4281 at http://www.fiercebiotech.com</guid>
</item>
<item>
 <title>SPOTLIGHT:  Synta trial hits endpoint</title>
 <link>http://www.fiercebiotech.com/story/spotlight-synta-trial-hits-endpoint/2006-09-15?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;P&gt;Synta Pharmaceuticals says that a Phase IIb clinical trial of STA-4783 doubled the progression free survival time of volunteers with metastatic melanoma in the study, hitting the study&#039;s primary endpoint for statistical significance. Median PFS for patients receiving STA-4783 plus paclitaxel was 112 days versus 56 days for those receiving paclitaxel alone. &lt;A href=&quot;http://www.medicalnewstoday.com/medicalnews.php?newsid=51602&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

</description>
 <comments>http://www.fiercebiotech.com/story/spotlight-synta-trial-hits-endpoint/2006-09-15#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/phase-ii">Phase II</category>
 <category domain="http://www.fiercebiotech.com/tags/synta-pharmaceuticals">Synta Pharmaceuticals</category>
 <pubDate>Thu, 14 Sep 2006 20:01:33 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">3918 at http://www.fiercebiotech.com</guid>
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<item>
 <title>ALSO NOTED:  Barr raises bid on Pliva; Synta touts new data; regulators question Factive rashes;and much more...</title>
 <link>http://www.fiercebiotech.com/story/also-noted-barr-raises-bid-on-pliva-synta-touts-new-data-regulators-questio/2006-09-11?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;P&gt;&amp;gt; Barr Pharmaceuticals has raised its bid for Pliva to $2.5 billion. &lt;A href=&quot;http://www.washingtonpost.com/wp-dyn/content/article/2006/09/11/AR2006091100390.html&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Synta Pharmaceuticals has released positive Phase IIB data for STA-4783, a heat shock protein 70 inducer that activates natural killer cell-mediated tumor killing in metastatic melanoma. Median progression free survival for patients receiving STA-4783 plus paclitaxel was 112 days versus 56 days for those receiving paclitaxel alone, a statistically significant difference that met the primary endpoint. STA-4783 was well-tolerated in the study, with adverse events typical of those expected for paclitaxel alone. &lt;A href=&quot;http://www.genengnews.com/news/bnitem.aspx?name=5684932&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; The FDA&#039;s regulatory staff has raised questions about the risk of skin rashes from Oscient&#039;s Factive antibiotic. &lt;A href=&quot;http://money.cnn.com/2006/09/11/news/companies/bc.health.oscient.reut/?postversion=2006091109&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Light Sciences Oncology has detailed plans to raise $96.6 million from the sale of 6 million shares. &lt;A href=&quot;http://www.bizjournals.com/seattle/stories/2006/09/04/daily30.html&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; J&amp;amp;J is touting new, mid-stage data on Natrecor. &lt;A href=&quot;http://today.reuters.com/news/articleinvesting.aspx?view=CN&amp;storyID=2006-09-11T145838Z_01_N11191863_RTRIDST_0_HEALTH-JOHNSONANDJOHNSON-UPDATE-1.XML&amp;rpc=66&amp;type=qcna&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; GlaxoSmithKline will settled a U.S. tax dispute for a reported $3.1 billion. &lt;A href=&quot;http://www.rte.ie/business/2006/0911/glaxo.html&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Venture capitalists and other investors have shown some real passion for India&#039;s pharma sector, but biotechnology is still largely being overlooked. &lt;A href=&quot;http://www.financialexpress.com/fe_full_story.php?content_id=140036&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Acuity Pharmaceuticals is touting positive results from its Phase II trial for bevasiranib sodium (formerly Cand5), its lead compound for the treatment of wet age-related macular degeneration. &lt;A href=&quot;http://biz.yahoo.com/prnews/060911/nym119.html?.v=46&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Amphora Discovery has created two stand-alone business units. The Amphora Pharmaceuticals Business Unit, based in Los Altos, CA, will focus on leveraging the company&#039;s high-value drug candidates and creating partnerships with pharmaceutical and biotech companies. The Amphora Discovery Business Unit, based in Durham NC, will offer a contract research offering. &lt;A href=&quot;http://biz.yahoo.com/prnews/060911/clm013.html?.v=59&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Codexis announced it hit a milestone in its research pact with Schering-Plough. &lt;A href=&quot;http://biz.yahoo.com/prnews/060911/sfm002.html?.v=66&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;And Finally&amp;#8230; &lt;/STRONG&gt;A new and frighteningly lethal strain of TB is spreading in South Africa. &lt;A href=&quot;http://www.cnn.com/2006/WORLD/africa/09/11/safrica.tb.reut/&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

</description>
 <category domain="http://www.fiercebiotech.com/tags/barr-laboratories">Barr Pharmaceuticals</category>
 <category domain="http://www.fiercebiotech.com/tags/glaxosmithkline">GlaxoSmithKline</category>
 <category domain="http://www.fiercebiotech.com/tags/macular-degeneration">macular degeneration</category>
 <category domain="http://www.fiercebiotech.com/tags/natrecor">natrecor</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/phase-ii">Phase II</category>
 <category domain="http://www.fiercebiotech.com/tags/schering-plough">Schering Plough</category>
 <category domain="http://www.fiercebiotech.com/tags/synta-pharmaceuticals">Synta Pharmaceuticals</category>
 <category domain="http://www.fiercebiotech.com/tags/venture-capitalists">Venture Capital</category>
 <pubDate>Sun, 10 Sep 2006 20:01:30 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">3880 at http://www.fiercebiotech.com</guid>
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<item>
 <title>ALSO NOTED:  FDA wants new NeoPharm trial; GSK may bid for Pfizer&#039;s OTC unit; and much more...</title>
 <link>http://www.fiercebiotech.com/story/also-noted-fda-wants-new-neopharm-trial-gsk-may-bid-for-pfizer-s-otc-unit-a/2006-02-09?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;P&gt;&amp;gt; NeoPharm says the FDA has requested that it undertake a new clinical trial to support its application for approval of a new formulation of the cancer drug liposomal paclitaxel. &lt;A href=&quot;http://www.businessweek.com/ap/financialnews/D8FLJU4G1.htm?campaign_id=apn_home_down&amp;chan=db&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; The Garvan Institute of Medical Research in Australia has found a new antibody for inflammatory diseases and that Novo Nordisk had agreed to provide up to $100 million to take it through clinical trials. &lt;A href=&quot;http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060208-050230-7686r&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; GlaxoSmithKline is signaling its interest in bidding for Pfizer&#039;s OTC unit. &lt;A href=&quot;http://business.guardian.co.uk/story/0,,1705538,00.html&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Pfizer has filed suit against Teva and Sandoz over a generic form of the antibiotic Zithromax. &lt;A href=&quot;http://seattlepi.nwsource.com/business/1310AP_Pfizer_Teva_Suit.html&quot;&gt;Article&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Merck claims that Mark Lanier, the attorney who won a $253 million Vioxx settlement, had been courting prominent cardiologist Eric Topol--one of Merck&#039;s chief critics--as a paid consultant. &lt;A href=&quot;http://seattlepi.nwsource.com/business/1310AP_Vioxx_Topol.html&quot;&gt;Article&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Doctors report that pregnant mothers taking antidepressants are more likely to give birth to a child suffering from a rare breathing disorder. &lt;A href=&quot;http://www.nytimes.com/2006/02/09/national/09depress.html&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Insert Therapeutics of Pasadena, CA has filed an IND to begin a Phase I trial of a new compound to treat patients with unresectable or metastatic solid tumors. &lt;A href=&quot;http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&amp;newsId=20060209005314&amp;newsLang=en&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Samaritan Pharmaceuticals has announced a $40 million common stock purchase deal. &lt;A href=&quot;http://www.genengnews.com/news/bnitem.aspx?name=1165100XSL_NEWSML_TO_NEWSML.xml&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&amp;gt; Shares of GTC Biotherapeutics took a dive, but company officials say they don&#039;t know why. &lt;A href=&quot;http://www.eyewitnessnewstv.com/Global/story.asp?S=4475275&amp;nav=F2DO&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;And Finally&amp;#8230; &lt;/STRONG&gt;Despite intense criticism that too many drug plans are creating confusion about the new Medicare drug benefit, Medicare chief Mark McClellan says he has no intention of reducing the number of plans in play. &lt;A href=&quot;http://www.usatoday.com/printedition/news/20060209/a_medicare09.art.htm?CFID=4315388&amp;CFTOKEN=114840769e6dd133-976E4936-F8C1-6860-D42FDD2A7863C01B&quot;&gt;Article&lt;/A&gt;&lt;/P&gt;

</description>
 <category domain="http://www.fiercebiotech.com/tags/cancer-drug">Cancer Drugs</category>
 <category domain="http://www.fiercebiotech.com/tags/glaxosmithkline">GlaxoSmithKline</category>
 <category domain="http://www.fiercebiotech.com/tags/inflammatory-diseases">inflammatory diseases</category>
 <category domain="http://www.fiercebiotech.com/tags/merck">Merck</category>
 <category domain="http://www.fiercebiotech.com/tags/neopharm">Neopharm</category>
 <category domain="http://www.fiercebiotech.com/tags/novo-nordisk">Novo Nordisk</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/pfizer">Pfizer</category>
 <category domain="http://www.fiercebiotech.com/tags/sandoz">sandoz</category>
 <category domain="http://www.fiercebiotech.com/tags/teva">Teva</category>
 <pubDate>Wed, 08 Feb 2006 19:00:50 -0500</pubDate>
 <dc:creator />
 <guid isPermaLink="false">2329 at http://www.fiercebiotech.com</guid>
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<item>
 <title>ALSO NOTED:  FDA requires electronic drug labeling; Niccotine vaccine on the horizon; Cancer drug could fight scleroderma; and m</title>
 <link>http://www.fiercebiotech.com/story/also-noted-fda-requires-electronic-drug-labeling-niccotine-vaccine-on-the-h/2005-11-03?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;P&gt;&amp;gt; The FDA said Wednesday that drug makers must begin submitting electronic versions of their drug labels to build a database that doctors and patients can search for recent warnings or other changes. &lt;A href=&quot;http://www.fda.gov/bbs/topics/NEWS/2005/NEW01252.html&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; Researchers presenting at the American Association for Cancer Research meeting in Baltimore on Wednesday reported strong safety and efficacy results for NicVAX, a vaccine that could help millions of smokers quit. There are several nicotine vaccines in development, but NicVax, which is closing in on phase 3 trial, will likely make it to the FDA first. &lt;A href=&quot;http://www.forbes.com/lifestyle/health/feeds/hscout/2005/11/02/hscout528837.html&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; Duke University Medical Center researchers have found that the anti cancer-drug paclitaxel (Taxol) may also prevent skin thickening and small blood vessel destruction in people with scleroderma. &lt;A href=&quot;http://abcnews.go.com/Health/Healthology/story?id=1274169&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&lt;STRONG&gt;&amp;gt;&lt;/STRONG&gt; King Pharmaceuticals will pay $124 million plus interest to settle allegations of Medicaid fraud. &lt;A href=&quot;http://www.philly.com/mld/inquirer/business/13056316.htm&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; GSK has opened a new $3 million facility in Cape Town, South Africa, to produce its de-worming agent albendazole. &lt;A href=&quot;http://sev.prnewswire.com/medical-pharmaceuticals/20051102/PHW03702112005-1.html&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&lt;STRONG&gt;And Finally...&lt;/STRONG&gt; The identity of Jack the Ripper may soon be revealed by DNA technology developed in Australia. &lt;A href=&quot;http://dailytelegraph.news.com.au/story/0,20281,17127432-5001022,00.html&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

</description>
 <category domain="http://www.fiercebiotech.com/tags/cancer-drug">Cancer Drugs</category>
 <category domain="http://www.fiercebiotech.com/tags/glaxosmithkline">GlaxoSmithKline</category>
 <category domain="http://www.fiercebiotech.com/tags/king-pharmaceuticals">King Pharmaceuticals</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <pubDate>Wed, 02 Nov 2005 19:00:50 -0500</pubDate>
 <dc:creator />
 <guid isPermaLink="false">1741 at http://www.fiercebiotech.com</guid>
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<item>
 <title>ALSO NOTED:  FDA wants more safety data on Pargluva; Genentech disappointed by Tarceva, Avastin combo; Schering takes stake in S</title>
 <link>http://www.fiercebiotech.com/story/also-noted-fda-wants-more-safety-data-on-pargluva-genentech-disappointed-by/2005-10-18?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;P&gt;&amp;gt; The FDA issued an &quot;approvable&quot; letter for Bristol-Myers Squibb&#039;s Pargluva but wants more safety data before it allows the drug to be marketed. An expert panel had recommended approval despite staff concerns about cardiovascular problems. &lt;A href=&quot;http://www.marketwatch.com/news/story.asp?guid=%7B3B77A101-7620-4F33-A40A-B846AAC6AC3A%7D&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; Genentech has decided to abandon studies of a combined regimen of Tarceva and Avastin for kidney cancer after finding the response rate was similar to Avastin alone. &lt;A href=&quot;http://www.forbes.com/home/feeds/afx/2005/10/18/afx2283794.html&quot;&gt;Article&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; Germany&#039;s Schering is taking a 15 percent equity stake in Sonus Pharmaceuticals in exchange for the global license to its Tocosol Paclitaxel cancer drug. &lt;A href=&quot;http://www.businessweek.com/ap/financialnews/D8DADT280.htm?campaign_id=apn_home_down&amp;chan=db&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; Xencor of Monrovia, CA, recently closed on a $20 million venture round led by Zen Investments. &lt;A href=&quot;http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&amp;newsId=20051018005441&amp;newsLang=en&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; Kosan Biosciences dropped a Phase II trial of a cancer drug after too few patients responded to treatment. &lt;A href=&quot;http://news.moneycentral.msn.com/provider/providerarticle.asp?feed=AP&amp;Date=20051018&amp;ID=5199835&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; GSK&#039;s Havrix has gained expanded approval for use in preventing hepatitis A in children 12 months and older. &lt;A href=&quot;http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&amp;STORY=/www/story/10-18-2005/0004171718&amp;EDATE=&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; Eli Lilly says that an experimental anti-clotting drug in development with Sankyo outperformed Plavix in head-to-head tests. &lt;A href=&quot;http://www.indystar.com/apps/pbcs.dll/article?AID=/20051018/BUSINESS/510180394&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; The University of Minnesota plans to pull licenses to its gene therapy work from the startup Discovery Genomics after the company failed to meet funding benchmarks. &lt;A href=&quot;http://www.bizjournals.com/industries/health_care/biotechnology/2005/10/17/twincities_story2.html&quot;&gt;Article&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; &lt;FONT color=#800000&gt;Chutes &amp;amp; Ladders:&lt;/FONT&gt; Zelos Therapeutics has named Brian MacDonald, MB, ChB, PhD, as CEO. &lt;A href=&quot;http://www.ccnmatthews.com/news/releases/show.jsp?action=showRelease&amp;actionFor=562920&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&lt;STRONG&gt;And Finally...&lt;/STRONG&gt; Voters in California are being presented with rival drug plans for the poor. &lt;A href=&quot;http://www.latimes.com/news/local/la-me-drugprops18oct18,0,6426102.story?coll=la-home-local&quot;&gt;Article&lt;/A&gt;&lt;/P&gt;

</description>
 <category domain="http://www.fiercebiotech.com/tags/avastin">Avastin</category>
 <category domain="http://www.fiercebiotech.com/tags/bristol-myers-squibb">Bristol-Myers Squibb</category>
 <category domain="http://www.fiercebiotech.com/tags/cancer-drug">Cancer Drugs</category>
 <category domain="http://www.fiercebiotech.com/tags/eli-lilly">Eli Lilly</category>
 <category domain="http://www.fiercebiotech.com/tags/genentech">Genentech</category>
 <category domain="http://www.fiercebiotech.com/tags/glaxosmithkline">GlaxoSmithKline</category>
 <category domain="http://www.fiercebiotech.com/tags/kidney-cancer">kidney cancer</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/plavix">Plavix</category>
 <category domain="http://www.fiercebiotech.com/tags/tarceva">Tarceva</category>
 <pubDate>Mon, 17 Oct 2005 20:00:50 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">1625 at http://www.fiercebiotech.com</guid>
</item>
<item>
 <title>ALSO NOTED:  Altana acquires dermatology business; BioDelivery prices shares; NeoPharm touts new version of cancer drug; and muc</title>
 <link>http://www.fiercebiotech.com/story/also-noted-altana-acquires-dermatology-business-biodelivery-prices-shares-n/2005-09-30?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;P&gt;&amp;gt; Altana of Melville, New York, has acquired the prescription dermatology business of GlaxoSmithKline Consumer Healthcare. &lt;A href=&quot;http://finanzen.net/news/news_detail.asp?NewsNr=338909&quot;&gt;Report&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; BioDelivery Sciences International has priced an offering of 4.4 million shares at $2 each. &lt;A href=&quot;http://www.genengnews.com/news/bnitem.aspx?name=1068632XSL_NEWSML_TO_NEWSML_WEB.xml&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; NeoPharm said a reformulated version of its paclitaxel cancer drug demonstrated fewer side effects. &lt;A href=&quot;http://www.businessweek.com/ap/financialnews/D8CU4T9G0.htm?campaign_id=apn_home_down&amp;chan=db&quot;&gt;Story&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; Shareholders of InKine and Salix Pharmaceuticals have endorsed the merger of the two companies. &lt;A href=&quot;http://www.genengnews.com/news/bnitem.aspx?name=1068681XSL_NEWSML_TO_NEWSML_WEB.xml&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; Progenics Pharmaceuticals of Scottsdale, Arizona, has hit its target enrollment for a second Phase III trial of methylnaltrexone for the treatment of opioid-induced constipation in patients with advanced medical illness. &lt;A href=&quot;http://www.genengnews.com/news/bnitem.aspx?name=1068578XSL_NEWSML_TO_NEWSML_WEB.xml&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&amp;gt; InSite Vision has completed enrollment in a Phase III trial of AzaSite for the treatment of bacterial conjunctivitis. &lt;A href=&quot;http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&amp;newsId=20050929005836&amp;newsLang=en&quot;&gt;Release&lt;/A&gt;&lt;/P&gt;

&lt;P&gt;&lt;STRONG&gt;And Finally&amp;#8230;&lt;/STRONG&gt; The governor of California terminated a bill that would have set up a Web site steering people to lower-cost Canadian, British and Irish medicine. In his veto, Schwarzenegger said he was worried that it was illegal, fraught with liability and dangerous for consumers. &lt;A href=&quot;http://www.rocklintoday.com/news/templates/community_news_lincoln.asp?articleid=2532&amp;zoneid=34&quot;&gt;Article&lt;/A&gt;&lt;/P&gt;

</description>
 <category domain="http://www.fiercebiotech.com/tags/altana">altana</category>
 <category domain="http://www.fiercebiotech.com/tags/cancer-drug">Cancer Drugs</category>
 <category domain="http://www.fiercebiotech.com/tags/neopharm">Neopharm</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/phase-iii">Phase III</category>
 <pubDate>Thu, 29 Sep 2005 20:00:50 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">1507 at http://www.fiercebiotech.com</guid>
</item>
<item>
 <title>Sanofi-Aventis touts survival data in Taxotere study</title>
 <link>http://www.fiercebiotech.com/story/sanofi-aventis-touts-survival-data-in-taxotere-study/2005-08-19?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;P&gt;In a head-to-head study of two of the most popular chemotherapies for breast cancer, Taxotere proved more effective than paclitaxel in prolonging women&#039;s lives for certain types of the disease. The study, published in the &lt;EM&gt;Journal of Clinical Oncology&lt;/EM&gt;, focused on women with advanced breast cancer. Women receiving Taxotere survived an average of 15.4 months compared to an overall 12.7 months for patients taking paclitaxel.&lt;/P&gt;

&lt;P&gt;- read this &lt;A href=&quot;http://www.forbes.com/home/feeds/afx/2005/08/19/afx2185760.html&quot;&gt;report&lt;/A&gt; from AFX for more&lt;/P&gt;

</description>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <pubDate>Thu, 18 Aug 2005 20:01:39 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">1218 at http://www.fiercebiotech.com</guid>
</item>
<item>
 <title>Sonus shares surge as FDA approves Phase III design</title>
 <link>http://www.fiercebiotech.com/story/sonus-shares-surge-as-fda-approves-phase-iii-design/2005-07-08?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
 <description>&lt;P&gt;Shares of Bothell, Washington-based Sonus Pharmaceuticals surged after the biotech announced that the FDA had approved its design for a Phase III trial of an experimental breast cancer therapy. The study will compare its Tocosol Paclitaxel against Taxol. Before the trial gets fully underway, though, Sonus needs to raise cash for the study.&lt;/P&gt;

&lt;P&gt;&quot;Our corporate development efforts are now focused on securing the necessary financial resources to support the study, and these efforts are ongoing on several fronts,&quot; said Michael A. Martino, President and CEO of Sonus. &quot;In parallel, we have already begun to study start-up activities for the Phase 3 trial.&quot;&lt;/P&gt;

&lt;P&gt;- read this &lt;A href=&quot;http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&amp;newsId=20050707005757&amp;newsLang=en&quot;&gt;press release&lt;/A&gt; for more&lt;/P&gt;

</description>
 <category domain="http://www.fiercebiotech.com/tags/fda-official">FDA</category>
 <category domain="http://www.fiercebiotech.com/tags/paclitaxel">Paclitaxel</category>
 <category domain="http://www.fiercebiotech.com/tags/phase-iii">Phase III</category>
 <pubDate>Thu, 07 Jul 2005 20:01:38 -0400</pubDate>
 <dc:creator />
 <guid isPermaLink="false">927 at http://www.fiercebiotech.com</guid>
</item>
</channel>
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