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    <title>Rx Drug News</title>
    <link>http://www.rxdrugnews.com/</link>
    <description></description>
    <dc:date>2012-05-17T05:02:00+04:00</dc:date>    

    <item>
      <title>J&amp;J drug shows promise in high&#45;risk prostate cancer</title>
      <link>http://www.rxdrugnews.com/site/more/jj&#45;drug&#45;shows&#45;promise/</link>
      <description>Adding Johnson &amp;amp; Johnson&#8217;s advanced prostate cancer drug, Zytiga, to hormone therapy before surgery has been shown for the first time to eradicate tumors in some men with high&#45;risk forms of the disease.


The mid&#45;stage trial found that six months of treatment with the combination therapy completely or nearly eliminated the cancer in a third of patients, all of whom had localized, aggressive cancer.


&#8220;These results are very impressive, especially given these high&#45;risk patients,&#8221; Dr Mary&#45;Ellen Taplin, associate professor of Medicine at Harvard Medical School and the study&#8217;s lead author, said at a news conference.</description>
      <dc:subject>Clinical Updates</dc:subject>
      <content:encoded><![CDATA[<p>Adding Johnson &amp; Johnson&#8217;s advanced prostate cancer drug, Zytiga, to hormone therapy before surgery has been shown for the first time to eradicate tumors in some men with high-risk forms of the disease.
</p>
<p>
The mid-stage trial found that six months of treatment with the combination therapy completely or nearly eliminated the cancer in a third of patients, all of whom had localized, aggressive cancer.
</p>
<p>
&#8220;These results are very impressive, especially given these high-risk patients,&#8221; Dr Mary-Ellen Taplin, associate professor of Medicine at Harvard Medical School and the study&#8217;s lead author, said at a news conference.
</p>]]></content:encoded>
      <dc:date>2012-05-17T05:02:00+04:00</dc:date>
      <pubDate>2012-05-17T05:02:00+04:00</pubDate>
    </item>


    <item>
      <title>FDA Panel Backs At&#45;Home HIV Test</title>
      <link>http://www.rxdrugnews.com/site/more/fda&#45;panel&#45;backs&#45;at&#45;home&#45;hiv&#45;test/</link>
      <description>A U.S. Food and Drug Administration advisory panel recommended Tuesday approval of the first HIV test that would give people the results in the privacy of their own home.


The 17 panel members were unanimous in voting that the benefits of the test were greater than any possible risks. The test kit, known as Oraquick, detects the presence of HIV&#8212;the virus that causes AIDS&#8212;within 20 minutes, the Associated Press reported.


If the FDA heeds the recommendation of its advisory panel, the decision could pave the way toward a new era in HIV testing. The agency typically follows the recommendations of its advisory groups.</description>
      <dc:subject>FDA Approvals</dc:subject>
      <content:encoded><![CDATA[<p>A U.S. Food and Drug Administration advisory panel recommended Tuesday approval of the first HIV test that would give people the results in the privacy of their own home.
</p>
<p>
The 17 panel members were unanimous in voting that the benefits of the test were greater than any possible risks. The test kit, known as Oraquick, detects the presence of HIV&#8212;the virus that causes AIDS&#8212;within 20 minutes, the Associated Press reported.
</p>
<p>
If the FDA heeds the recommendation of its advisory panel, the decision could pave the way toward a new era in HIV testing. The agency typically follows the recommendations of its advisory groups.
</p>]]></content:encoded>
      <dc:date>2012-05-16T11:40:00+04:00</dc:date>
      <pubDate>2012-05-16T11:40:00+04:00</pubDate>
    </item>


    <item>
      <title>Pfizer, Inc. anticipate the FDA’s decision on tofacitinib, a new arthritis drug</title>
      <link>http://www.rxdrugnews.com/site/more/tofacitinib&#45;a&#45;new&#45;arthritis&#45;drug/</link>
      <description>The Food and Drug Administration is questioning the benefits and risks of a new rheumatoid arthritis drug created by Pfizer, Inc. Some possible risks of taking the drug, called tofacitinib, include an increase of lymphoma cancer cells, as well as infections. The purpose of the drug is to reduce swollen and tender joints. Pfizer could regain its renowned reputation since their release of Viagra over 10 years ago.


If the arthritis drug’s benefits are proven to trump its risks, and the drug approved, revenue is expected to reach $2 billion to $3 billion a year. The arthritis drug would be the first antirheumatic drug to be taken by mouth. Rheumatoid arthritis poses as one of the most lucrative diseases, earning drug companies $20 billion a year, as 1 percent of the American adult population suffers from the disease.</description>
      <dc:subject></dc:subject>
      <content:encoded><![CDATA[<p>The Food and Drug Administration is questioning the benefits and risks of a new rheumatoid arthritis drug created by Pfizer, Inc. Some possible risks of taking the drug, called tofacitinib, include an increase of lymphoma cancer cells, as well as infections. The purpose of the drug is to reduce swollen and tender joints. Pfizer could regain its renowned reputation since their release of Viagra over 10 years ago.
</p>
<p>
If the arthritis drug’s benefits are proven to trump its risks, and the drug approved, revenue is expected to reach $2 billion to $3 billion a year. The arthritis drug would be the first antirheumatic drug to be taken by mouth. Rheumatoid arthritis poses as one of the most lucrative diseases, earning drug companies $20 billion a year, as 1 percent of the American adult population suffers from the disease.
</p>]]></content:encoded>
      <dc:date>2012-05-10T21:18:00+04:00</dc:date>
      <pubDate>2012-05-10T21:18:00+04:00</pubDate>
    </item>


    <item>
      <title>FDA accepts Pfizer&#8217;s tofacitinib NDA for review</title>
      <link>http://www.rxdrugnews.com/site/more/fda&#45;accepts&#45;pfizers&#45;tofacitinib&#45;nda&#45;for&#45;review/</link>
      <description>Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP&#45;690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in August 2012 for the NDA. Pfizer has also submitted an application for this indication for tofacitinib to regulatory authorities in Japan.


As disclosed in November, an application for tofacitinib for the treatment of adult patients with moderate&#45;to&#45;severe active RA is being reviewed by the European Medicines Agency.</description>
      <dc:subject>FDA Approvals</dc:subject>
      <content:encoded><![CDATA[<p>Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in August 2012 for the NDA. Pfizer has also submitted an application for this indication for tofacitinib to regulatory authorities in Japan.
</p>
<p>
As disclosed in November, an application for tofacitinib for the treatment of adult patients with moderate-to-severe active RA is being reviewed by the European Medicines Agency.
</p>]]></content:encoded>
      <dc:date>2012-05-10T05:20:00+04:00</dc:date>
      <pubDate>2012-05-10T05:20:00+04:00</pubDate>
    </item>


    <item>
      <title>Pfizer&#8217;s Tofacitinib Takes Next Step To Combat Arthritis</title>
      <link>http://www.rxdrugnews.com/site/more/pfizers&#45;tofacitinib&#45;takes&#45;next&#45;step/</link>
      <description>Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. Now Pfizer has announced progress for their drug tofacitinib. Tofacitinib is a unique, oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease&#45;modifying therapy for RA. 


More than 4,000 RA patients have been treated with tofacitinib in clinical trials to date. RA affects approximately 1.3 million people in the U.S. and one percent of the adult population worldwide. 


The Janus kinase family is one of ten recognized families of non&#45;receptor tyrosine kinases. Mammals have four members of this family, Jak1, Jak2, Jak3 and Tyrosine kinase 2 (Tyk2). 


Each protein has a kinase domain and a catalytically inactive pseudo&#45;kinase domain, and they each bind cytokine receptors through amino&#45;terminal FERM (Band&#45;4.1, ezrin, radixin, moesin) domains. Upon binding of cytokines to their receptors, Jaks are activated and phosphorylate the receptors, creating docking sites for signaling molecules, especially members of the signal transducer and activator of transcription family. Mutations of the Drosophila Jak (Hopscotch) have revealed developmental defects, and constitutive activation of Jaks in flies and humans is associated with leukemia&#45;like syndromes.&amp;nbsp;</description>
      <dc:subject>Clinical Updates</dc:subject>
      <content:encoded><![CDATA[<p>Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. Now Pfizer has announced progress for their drug tofacitinib. Tofacitinib is a unique, oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA. 
</p>
<p>
More than 4,000 RA patients have been treated with tofacitinib in clinical trials to date. RA affects approximately 1.3 million people in the U.S. and one percent of the adult population worldwide. 
</p>
<p>
The Janus kinase family is one of ten recognized families of non-receptor tyrosine kinases. Mammals have four members of this family, Jak1, Jak2, Jak3 and Tyrosine kinase 2 (Tyk2). 
</p>
<p>
Each protein has a kinase domain and a catalytically inactive pseudo-kinase domain, and they each bind cytokine receptors through amino-terminal FERM (Band-4.1, ezrin, radixin, moesin) domains. Upon binding of cytokines to their receptors, Jaks are activated and phosphorylate the receptors, creating docking sites for signaling molecules, especially members of the signal transducer and activator of transcription family. Mutations of the Drosophila Jak (Hopscotch) have revealed developmental defects, and constitutive activation of Jaks in flies and humans is associated with leukemia-like syndromes.&nbsp;
</p>]]></content:encoded>
      <dc:date>2012-05-10T05:20:00+04:00</dc:date>
      <pubDate>2012-05-10T05:20:00+04:00</pubDate>
    </item>


    <item>
      <title>Probe finds collusion between India&#8217;s drug regulator, pharma firms</title>
      <link>http://www.rxdrugnews.com/site/more/indias&#45;drug&#45;regulator&#45;pharma&#45;firms/</link>
      <description>Officials of India&#8217;s drug regulator have been colluding with pharmaceutical firms to speed up approval procedures, allowing some drugs that are not permitted in other countries to go on sale, according to an 18&#45;month investigation by lawmakers.


The parliamentary panel&#8217;s 78&#45;page report names a number of major international drug companies and Indian firms.


The report may fuel concerns over lax supervision of the global industry in emerging markets, where Western drug manufacturers are increasingly focusing their sales effort.</description>
      <dc:subject>Drug News</dc:subject>
      <content:encoded><![CDATA[<p>Officials of India&#8217;s drug regulator have been colluding with pharmaceutical firms to speed up approval procedures, allowing some drugs that are not permitted in other countries to go on sale, according to an 18-month investigation by lawmakers.
</p>
<p>
The parliamentary panel&#8217;s 78-page report names a number of major international drug companies and Indian firms.
</p>
<p>
The report may fuel concerns over lax supervision of the global industry in emerging markets, where Western drug manufacturers are increasingly focusing their sales effort.
</p>]]></content:encoded>
      <dc:date>2012-05-10T05:18:00+04:00</dc:date>
      <pubDate>2012-05-10T05:18:00+04:00</pubDate>
    </item>


    <item>
      <title>GSK goes hostile with $2.6 billion Human Genome offer</title>
      <link>http://www.rxdrugnews.com/site/more/gsk&#45;goes&#45;hostile&#45;with&#45;26&#45;billion/</link>
      <description>GlaxoSmithKline will take its $2.6 billion bid for long&#45;time partner Human Genome Sciences direct to shareholders this week, after its takeover offer was rejected last month by the U.S. biotech group&#8217;s board.


The decision to go hostile with the $13&#45;a&#45;share cash tender offer sets up GSK for a potentially lengthy battle with those Human Genome investors who believe it is not offering enough.


&#8220;They will do fantastically well out of this &#45; at $13 it is a steal,&#8221; said Mark Evans, a fund manager at Taube Hodson Stonex, the sixth largest investor in Human Genome with a 5.6 percent stake. &#8220;I still think it is very likely that they will have to pay more.&#8221;</description>
      <dc:subject>Drug News</dc:subject>
      <content:encoded><![CDATA[<p>GlaxoSmithKline will take its $2.6 billion bid for long-time partner Human Genome Sciences direct to shareholders this week, after its takeover offer was rejected last month by the U.S. biotech group&#8217;s board.
</p>
<p>
The decision to go hostile with the $13-a-share cash tender offer sets up GSK for a potentially lengthy battle with those Human Genome investors who believe it is not offering enough.
</p>
<p>
&#8220;They will do fantastically well out of this - at $13 it is a steal,&#8221; said Mark Evans, a fund manager at Taube Hodson Stonex, the sixth largest investor in Human Genome with a 5.6 percent stake. &#8220;I still think it is very likely that they will have to pay more.&#8221;
</p>]]></content:encoded>
      <dc:date>2012-05-10T05:17:01+04:00</dc:date>
      <pubDate>2012-05-10T05:17:01+04:00</pubDate>
    </item>


    <item>
      <title>Dog food salmonella recall expanded in U.S., Canada</title>
      <link>http://www.rxdrugnews.com/site/more/dog&#45;food&#45;salmonella&#45;recall&#45;expanded/</link>
      <description>Diamond Pet Foods has expanded a recall of its dry dog food, taking precautionary steps after several of its brands were linked to an outbreak of a rare strain of salmonella poisoning that infected at least 14 people in nine states.


The company said it was now pulling a total of nine brands of its dry dog food from the shelves. In April, it began the recall by pulling three brands.


The salmonella cases were found in humans who may have had contact with dogs or dog foods prior to their illness.</description>
      <dc:subject>Clinical Updates</dc:subject>
      <content:encoded><![CDATA[<p>Diamond Pet Foods has expanded a recall of its dry dog food, taking precautionary steps after several of its brands were linked to an outbreak of a rare strain of salmonella poisoning that infected at least 14 people in nine states.
</p>
<p>
The company said it was now pulling a total of nine brands of its dry dog food from the shelves. In April, it began the recall by pulling three brands.
</p>
<p>
The salmonella cases were found in humans who may have had contact with dogs or dog foods prior to their illness.
</p>]]></content:encoded>
      <dc:date>2012-05-08T04:47:00+04:00</dc:date>
      <pubDate>2012-05-08T04:47:00+04:00</pubDate>
    </item>


    <item>
      <title>Preview: U.S. panel seen backing Pfizer&#8217;s arthritis drug hope</title>
      <link>http://www.rxdrugnews.com/site/more/backing&#45;pfizers&#45;arthritis&#45;drug&#45;hope/</link>
      <description>Pfizer Inc&#8217;s experimental rheumatoid arthritis drug goes before an advisory panel next week, a potential blockbuster medicine that would revive faith in the company&#8217;s research if its benefits are deemed to outweigh its side effects.


Most industry analysts expect the Food and Drug Administration&#8217;s expert committee to recommend approval despite risks posed by higher&#45;than&#45;normal cholesterol and liver enzyme levels and infections for patients taking tofacitinib during clinical trials.


The pill is one of Pfizer&#8217;s biggest pipeline hopes and could become one of the few major new medicines to come from its own laboratories since impotence treatment Viagra more than a decade ago. If approved, the likely cheaper pill would compete with widely used injectable medicines, including Abbott Laboratories Inc&#8217;s $8 billion&#45;a&#45;year Humira.</description>
      <dc:subject>Clinical Updates</dc:subject>
      <content:encoded><![CDATA[<p>Pfizer Inc&#8217;s experimental rheumatoid arthritis drug goes before an advisory panel next week, a potential blockbuster medicine that would revive faith in the company&#8217;s research if its benefits are deemed to outweigh its side effects.
</p>
<p>
Most industry analysts expect the Food and Drug Administration&#8217;s expert committee to recommend approval despite risks posed by higher-than-normal cholesterol and liver enzyme levels and infections for patients taking tofacitinib during clinical trials.
</p>
<p>
The pill is one of Pfizer&#8217;s biggest pipeline hopes and could become one of the few major new medicines to come from its own laboratories since impotence treatment Viagra more than a decade ago. If approved, the likely cheaper pill would compete with widely used injectable medicines, including Abbott Laboratories Inc&#8217;s $8 billion-a-year Humira.
</p>]]></content:encoded>
      <dc:date>2012-05-04T20:31:00+04:00</dc:date>
      <pubDate>2012-05-04T20:31:00+04:00</pubDate>
    </item>


    <item>
      <title>Combination of two drugs reverses liver tumours</title>
      <link>http://www.rxdrugnews.com/site/more/combination&#45;of&#45;two&#45;drugs&#45;reverses&#45;liver&#45;tumours/</link>
      <description>The combination of two inhibitors of protein mTOR stops the growth of primary liver cancer and destroys tumour cells, according to a study by researchers of the Group of Metabolism and Cancer at Bellvitge Biomedical Research Institute (IDIBELL). The study results are been published on the online edition of the journal Science Translational Medicine.


Primary liver cancer or hepatocellular carcinoma is the fifth most common cancer and, due to its aggressiveness, is the third most deadly. It affects half a million people worldwide. Two of every three cases are related to chronic alcoholism, the exposure of toxic agents or infection with hepatitis B or C. The remaining third is related to non&#45;alcoholic steatohepatitis, a disease related to obesity.


Promising candidates

Currently, the antitumor sorafenib shows the better patient outcomes, but its effectiveness decreases over time. For this reason, it is necessary to find new therapies. Among the most promising candidates are the inhibitors of the mTOR signalling pathway, which is hyperactivated in half of those affected by hepatocellular carcinoma.</description>
      <dc:subject>Clinical Updates</dc:subject>
      <content:encoded><![CDATA[<p>The combination of two inhibitors of protein mTOR stops the growth of primary liver cancer and destroys tumour cells, according to a study by researchers of the Group of Metabolism and Cancer at Bellvitge Biomedical Research Institute (IDIBELL). The study results are been published on the online edition of the journal Science Translational Medicine.
</p>
<p>
Primary liver cancer or hepatocellular carcinoma is the fifth most common cancer and, due to its aggressiveness, is the third most deadly. It affects half a million people worldwide. Two of every three cases are related to chronic alcoholism, the exposure of toxic agents or infection with hepatitis B or C. The remaining third is related to non-alcoholic steatohepatitis, a disease related to obesity.
</p>
<p>
<b>Promising candidates</b>
<br />
Currently, the antitumor sorafenib shows the better patient outcomes, but its effectiveness decreases over time. For this reason, it is necessary to find new therapies. Among the most promising candidates are the inhibitors of the mTOR signalling pathway, which is hyperactivated in half of those affected by hepatocellular carcinoma.
</p>]]></content:encoded>
      <dc:date>2012-05-02T20:48:00+04:00</dc:date>
      <pubDate>2012-05-02T20:48:00+04:00</pubDate>
    </item>


    <item>
      <title>Drug and device trials vary in size, quality: study</title>
      <link>http://www.rxdrugnews.com/site/more/drug&#45;and&#45;device&#45;trials&#45;vary/</link>
      <description>In an analysis of over 40,000 clinical trials registered in a government database, researchers found that many of those studies &#45; looking at the effects of drugs, devices or behavioral interventions &#45; were small and of inconsistent quality.


Those are the studies doctor groups rely on when it comes to setting guidelines about the best evidence for preventing and treating a given disease, according to a report led by Dr. Robert Califf at the Duke Translational Medicine Institute in Durham, North Carolina.


But if the evidence comes from small groups of patients in trials with less&#45;than&#45;reliable methods, doctors are left without a lot to work with when developing recommendations and making decisions in everyday care.


&#8220;What&#8217;s at stake for the public is, you would want your doctor to know what he or she is doing as opposed to just guessing or having an opinion,&#8221; Califf told Reuters Health.</description>
      <dc:subject>Clinical Updates</dc:subject>
      <content:encoded><![CDATA[<p>In an analysis of over 40,000 clinical trials registered in a government database, researchers found that many of those studies - looking at the effects of drugs, devices or behavioral interventions - were small and of inconsistent quality.
</p>
<p>
Those are the studies doctor groups rely on when it comes to setting guidelines about the best evidence for preventing and treating a given disease, according to a report led by Dr. Robert Califf at the Duke Translational Medicine Institute in Durham, North Carolina.
</p>
<p>
But if the evidence comes from small groups of patients in trials with less-than-reliable methods, doctors are left without a lot to work with when developing recommendations and making decisions in everyday care.
</p>
<p>
&#8220;What&#8217;s at stake for the public is, you would want your doctor to know what he or she is doing as opposed to just guessing or having an opinion,&#8221; Califf told Reuters Health.
</p>]]></content:encoded>
      <dc:date>2012-05-02T06:24:00+04:00</dc:date>
      <pubDate>2012-05-02T06:24:00+04:00</pubDate>
    </item>


    <item>
      <title>Pfizer says on lookout for mid&#45;size drug deals</title>
      <link>http://www.rxdrugnews.com/site/more/mid&#45;size&#45;drug&#45;deals/</link>
      <description>Pfizer Inc, which last week agreed to sell its baby formula business for almost $12 billion, is on the hunt for companies with promising new treatments for diabetes, cancer and neurological conditions, and willing to spend $4 billion or more apiece, company Chief Executive Ian Read said.


&#8220;I have no interest in a massive consolidating deal,&#8221; Read said in an interview, referring to giant transactions like Pfizer&#8217;s $67 billion purchase of rival U.S. drugmaker Wyeth in 2009, or its $60 billion merger with Pharmacia in 2003.


Read said Pfizer has an eye out for smaller &#8220;bolt&#45;on&#8221; deals of roughly the same size as its $3.6 billion purchase of King Pharmaceuticals last year for its roster of pain medicines.


&#8220;That&#8217;s not a hard number &#45; around that (amount) or a multiple of that if it was an attractive asset,&#8221; Read said in an interview after Pfizer reported solid quarterly earnings despite generic competition that battered sales of its Lipitor cholesterol fighter.</description>
      <dc:subject>Drug News</dc:subject>
      <content:encoded><![CDATA[<p>Pfizer Inc, which last week agreed to sell its baby formula business for almost $12 billion, is on the hunt for companies with promising new treatments for diabetes, cancer and neurological conditions, and willing to spend $4 billion or more apiece, company Chief Executive Ian Read said.
</p>
<p>
&#8220;I have no interest in a massive consolidating deal,&#8221; Read said in an interview, referring to giant transactions like Pfizer&#8217;s $67 billion purchase of rival U.S. drugmaker Wyeth in 2009, or its $60 billion merger with Pharmacia in 2003.
</p>
<p>
Read said Pfizer has an eye out for smaller &#8220;bolt-on&#8221; deals of roughly the same size as its $3.6 billion purchase of King Pharmaceuticals last year for its roster of pain medicines.
</p>
<p>
&#8220;That&#8217;s not a hard number - around that (amount) or a multiple of that if it was an attractive asset,&#8221; Read said in an interview after Pfizer reported solid quarterly earnings despite generic competition that battered sales of its Lipitor cholesterol fighter.
</p>]]></content:encoded>
      <dc:date>2012-05-02T05:49:01+04:00</dc:date>
      <pubDate>2012-05-02T05:49:01+04:00</pubDate>
    </item>


    <item>
      <title>U.S. needs better way to track drug safety &#45; study</title>
      <link>http://www.rxdrugnews.com/site/more/way&#45;to&#45;track&#45;drug&#45;safety/</link>
      <description>The U.S. Food and Drug Administration should review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues, according to a report from an independent research body.


The Institute of Medicine, which often advises the government on scientific matters, said the FDA should then create a comprehensive, publicly available document that reflects risks that crop up throughout the &#8220;lifecycle&#8221; of the drug.


The FDA has been criticized for not quickly responding to dangerous side effects that become more evident after a product is brought to market, such as with Vioxx, a painkiller that Merck &amp;amp; Co In pulled five years after approval because of a link to heart attacks and strokes.</description>
      <dc:subject>Medical Product Safety Alerts</dc:subject>
      <content:encoded><![CDATA[<p>The U.S. Food and Drug Administration should review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues, according to a report from an independent research body.
</p>
<p>
The Institute of Medicine, which often advises the government on scientific matters, said the FDA should then create a comprehensive, publicly available document that reflects risks that crop up throughout the &#8220;lifecycle&#8221; of the drug.
</p>
<p>
The FDA has been criticized for not quickly responding to dangerous side effects that become more evident after a product is brought to market, such as with Vioxx, a painkiller that Merck &amp; Co In pulled five years after approval because of a link to heart attacks and strokes.
</p>]]></content:encoded>
      <dc:date>2012-05-01T19:33:00+04:00</dc:date>
      <pubDate>2012-05-01T19:33:00+04:00</pubDate>
    </item>


    <item>
      <title>Antibiotic for plague approved by the FDA</title>
      <link>http://www.rxdrugnews.com/site/more/antibiotic&#45;for&#45;plague&#45;approved&#45;by&#45;the&#45;fda/</link>
      <description>A plague outbreak could be extremely deadly, so much so that officials warn it can be used in a bioterror attack. Now U.S regulators have approved use of a powerful Johnson &amp;amp; Johnson antibiotic to treat and prevent the extremely rare but potentially deadly bacterial infection.


The U.S. Food and Drug Administration also approved Levaquin, known generically as levofloxacin, to reduce risk of people getting plague after exposure to the bacteria that causes it, called Yersinia pestis.


Plague mainly occurs in animals. People can get it from bites from infected fleas or contact with infected animals or humans. About 1,000 to 2,000 human cases occur worldwide each year.</description>
      <dc:subject>FDA Approvals</dc:subject>
      <content:encoded><![CDATA[<p>A plague outbreak could be extremely deadly, so much so that officials warn it can be used in a bioterror attack. Now U.S regulators have approved use of a powerful Johnson &amp; Johnson antibiotic to treat and prevent the extremely rare but potentially deadly bacterial infection.
</p>
<p>
The U.S. Food and Drug Administration also approved Levaquin, known generically as levofloxacin, to reduce risk of people getting plague after exposure to the bacteria that causes it, called Yersinia pestis.
</p>
<p>
Plague mainly occurs in animals. People can get it from bites from infected fleas or contact with infected animals or humans. About 1,000 to 2,000 human cases occur worldwide each year.
</p>]]></content:encoded>
      <dc:date>2012-04-30T20:43:00+04:00</dc:date>
      <pubDate>2012-04-30T20:43:00+04:00</pubDate>
    </item>


    <item>
      <title>Army researcher develops potential vaccine carrier</title>
      <link>http://www.rxdrugnews.com/site/more/develops&#45;potential&#45;vaccine&#45;carrier/</link>
      <description>A researcher at the Brooke Army Medical Center (BAMC)/San Antonio Military Medical Center (SAMMC) will present findings this week on a new potential vaccine carrier that he hopes will extend the shelf life of and aid in the stockpiling of critical vaccines.


U.S. Army Maj. Jean M. Muderhwa is slated to present at 12:25 p.m. Sunday, April 22, at the Experimental Biology 2012 meeting on a microemulsion he developed and that has been found to be both stable and a good candidate for delivering a variety of antigens. His findings will be presented at the American Society for Biochemistry and Molecular Biology&#8217;s annual meeting, which is part of EB2012.


&#8220;There is a synergy here,&#8221; Muderhwa said of the microemulsion. &#8220;What I found is a composition that is transparent, is liquid and that has been sitting there (on my shelf) for six months&#8221; without degrading.


Muderhwa, deputy laboratory director at the Medical Center&#8217;s Clinical Investigation Department, made the microemulsion with what seems like a simple recipe with five components, but it&#8217;s how those five components interact that is quite special. He is hopeful that forthcoming animal studies will show the full potential for the recipe.</description>
      <dc:subject>Drug News</dc:subject>
      <content:encoded><![CDATA[<p>A researcher at the Brooke Army Medical Center (BAMC)/San Antonio Military Medical Center (SAMMC) will present findings this week on a new potential vaccine carrier that he hopes will extend the shelf life of and aid in the stockpiling of critical vaccines.
</p>
<p>
U.S. Army Maj. Jean M. Muderhwa is slated to present at 12:25 p.m. Sunday, April 22, at the Experimental Biology 2012 meeting on a microemulsion he developed and that has been found to be both stable and a good candidate for delivering a variety of antigens. His findings will be presented at the American Society for Biochemistry and Molecular Biology&#8217;s annual meeting, which is part of EB2012.
</p>
<p>
&#8220;There is a synergy here,&#8221; Muderhwa said of the microemulsion. &#8220;What I found is a composition that is transparent, is liquid and that has been sitting there (on my shelf) for six months&#8221; without degrading.
</p>
<p>
Muderhwa, deputy laboratory director at the Medical Center&#8217;s Clinical Investigation Department, made the microemulsion with what seems like a simple recipe with five components, but it&#8217;s how those five components interact that is quite special. He is hopeful that forthcoming animal studies will show the full potential for the recipe.
</p>]]></content:encoded>
      <dc:date>2012-04-23T20:11:00+04:00</dc:date>
      <pubDate>2012-04-23T20:11:00+04:00</pubDate>
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