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      <title>Biopharma exec settles with SEC over misappropriation claims</title>
      <description>
        <![CDATA[The U.S. SEC filed a settlement April 29 that it reached with Anthony Cataldo regarding allegations that the former chairman and CEO of a clinical-stage biopharma company misappropriated about $3.2 million from the company and then concealed the misconduct from the company’s auditors.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730830</guid>
      <pubDate>Thu, 30 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730830-biopharma-exec-settles-with-sec-over-misappropriation-claims</link>
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    <item>
      <title>HHS appeals federal injunction ruling on vaccine changes</title>
      <description>
        <![CDATA[The U.S. Department of Health and Human Services (HHS) has appealed a recent federal ruling that put on hold several changes to the childhood vaccine schedule and the Advisory Committee on Immunization Practices as reconstituted by HHS Secretary Robert Kennedy.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730754</guid>
      <pubDate>Thu, 30 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730754-hhs-appeals-federal-injunction-ruling-on-vaccine-changes</link>
    </item>
    <item>
      <title>Purdue sentenced in federal court, ordered to pay $5B</title>
      <description>
        <![CDATA[More than five years after pleading guilty to its role in the opioid epidemic, Purdue Pharma LP was sentenced in federal court and ordered to pay $5 billion in criminal penalties.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730810</guid>
      <pubDate>Wed, 29 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730810-purdue-sentenced-in-federal-court-ordered-to-pay-5b</link>
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      <title>Supremes weigh in on skinny labels in long-awaited argument </title>
      <description>
        <![CDATA[The U.S. Supreme Court’s ruling in <em>Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc.</em> could either discourage the development of generic drugs under a skinny label or make innovators think long and hard about investing hundreds of millions of dollars in developing new indications for drugs already on the market.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730682</guid>
      <pubDate>Wed, 29 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730682-supremes-weigh-in-on-skinny-labels-in-long-awaited-argument</link>
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        <media:title type="plain">Decorative scales of justice in a courtroom</media:title>
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      <title>Fed Circuit hands headache patent win back to Teva</title>
      <description>
        <![CDATA[Ever since Teva Pharmaceutical Industries Ltd. sued Eli Lilly and Co. several years ago, claiming Lilly’s migraine drug, Emgality (galcanezumab), infringed its headache treatment patents, the two companies have been on a litigation rollercoaster.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730484</guid>
      <pubDate>Tue, 21 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730484-fed-circuit-hands-headache-patent-win-back-to-teva</link>
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        <media:title type="plain">Ajovy</media:title>
        <media:description type="plain">Credit: Business Wire</media:description>
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      <title>Maryland 340B law likely pre-empted, appeals court rules </title>
      <description>
        <![CDATA[Given its recent decision in a challenge to a West Virginia law, it’s no surprise that the U.S. Court of Appeals for the Fourth Circuit issued a 2-1 unpublished opinion April 14 overturning a lower court that had refused a preliminary injunction to stall a similar Maryland law that would require drug manufacturers to offer 340B prescription drug discounts to unlimited contract pharmacies.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730315</guid>
      <pubDate>Thu, 16 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730315-maryland-340b-law-likely-pre-empted-appeals-court-rules</link>
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      <title>Kennedy sidestepping court order sidelining ACIP?</title>
      <description>
        <![CDATA[Don’t like a court order? Sidestep it. That seems to be the idea behind U.S. Health and Human Services Secretary Robert Kennedy’s latest changes to his renewal of the charter for the CDC’s Advisory Committee on Immunization Practices (ACIP).]]>
      </description>
      <guid>http://www.bioworld.com/articles/730135</guid>
      <pubDate>Tue, 07 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730135-kennedy-sidestepping-court-order-sidelining-acip</link>
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        <media:title type="plain">Businessman signing documents</media:title>
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    <item>
      <title>Circuit split forming over state 340B laws </title>
      <description>
        <![CDATA[Do state laws requiring drug companies to give steep 340B drug discounts to an unlimited number of contract pharmacies, with no claims data required, interfere with a longstanding contract between the U.S. Congress and biopharma? Or do such laws merely flex states’ authority over pharmacy practices such as delivery?]]>
      </description>
      <guid>http://www.bioworld.com/articles/730117</guid>
      <pubDate>Mon, 06 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730117-circuit-split-forming-over-state-340b-laws</link>
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        <media:title type="plain">Gavel and pill blister packs</media:title>
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      <title>Trade secret theft results in loss of US citizenship </title>
      <description>
        <![CDATA[On top of prison sentences, loss of assets and a $2.6 million restitution order issued several years ago, Li Chen and Yu Zhou had their naturalized U.S. citizenship revoked March 30 as a consequence of stealing exosome-related trade secrets from Nationwide Children's Hospital's Research Institute in Ohio – the hospital that had sponsored them when they first came to the U.S. from China on H-1B Specialty Occupation visas.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729983</guid>
      <pubDate>Wed, 01 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/729983-trade-secret-theft-results-in-loss-of-us-citizenship</link>
    </item>
    <item>
      <title>Supreme Court shuts the door to three life sciences petitions</title>
      <description>
        <![CDATA[What do a patent dispute over a CRISPR/Cas system, a rejected whistleblower case involving lab tests and a vaccine injury claim parading as multidistrict tort litigation have in common? All three were denied cert in the U.S. Supreme Court’s latest orders list.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729967</guid>
      <pubDate>Tue, 31 Mar 2026 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/729967-supreme-court-shuts-the-door-to-three-life-sciences-petitions</link>
    </item>
    <item>
      <title>US Supreme Court says no to Takeda class action challenge </title>
      <description>
        <![CDATA[Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in <em>Takeda Pharmaceutical v. Painters & Allied Trade</em>s, which sought to rein in the expansion of class action lawsuits.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729874</guid>
      <pubDate>Mon, 23 Mar 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/729874-us-supreme-court-says-no-to-takeda-class-action-challenge</link>
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        <media:title type="plain">Architectural pillars</media:title>
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      <title>340B provider finds new way into court over Rx price disputes </title>
      <description>
        <![CDATA[Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729559</guid>
      <pubDate>Wed, 18 Mar 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/729559-340b-provider-finds-new-way-into-court-over-rx-price-disputes</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Legal-scales-and-clipboard.webp?t=1773867848" type="image/jpeg" medium="image" fileSize="372138">
        <media:title type="plain">Legal scales and clipboard</media:title>
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      <title>Judge’s order shuts down new vaccine schedule, ACIP itself </title>
      <description>
        <![CDATA[In one fell swoop March 16, a U.S. federal judge stayed the CDC’s January memo revising the childhood vaccine schedule and the Advisory Committee on Immunization Practices (ACIP) as reconstituted by Health and Human Services Secretary Robert Kennedy, along with everything that committee has done since early June.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729544</guid>
      <pubDate>Tue, 17 Mar 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/729544-judges-order-shuts-down-new-vaccine-schedule-acip-itself</link>
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        <media:title type="plain">Gavel, stethoscope, vial and syringe</media:title>
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    <item>
      <title>Moderna to pay up to $2.25B to settle COVID-19 patents case</title>
      <description>
        <![CDATA[In what it says could be the largest disclosed patent settlement in the pharmaceutical industry, Roivant Sciences Ltd. has reached a potential $2.25 billion settlement with Moderna Inc. over the use of its lipid nanoparticle delivery technology in the Spikevax COVID-19 vaccine.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729387</guid>
      <pubDate>Wed, 04 Mar 2026 08:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/729387-moderna-to-pay-up-to-225b-to-settle-covid-19-patents-case</link>
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        <media:title type="plain">Spikevax vial and product packaging</media:title>
        <media:description type="plain">Credit: Moderna Inc.</media:description>
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      <title>Ninth Circuit agrees with Lilly in royalty dispute </title>
      <description>
        <![CDATA[Eli Lilly and Co. got a breather when the U.S. Ninth Circuit Court of Appeals agreed that the company doesn’t owe Research Corporation Technologies Inc. (RCT) royalties on its diabetes drugs under a licensing agreement Lilly had made with Phillips Petroleum Co. in 1990 and that Phillips later sold to RCT.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729246</guid>
      <pubDate>Thu, 26 Feb 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/729246-ninth-circuit-agrees-with-lilly-in-royalty-dispute</link>
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    <item>
      <title>Another lawsuit challenges changes to ACIP, US vaccine schedule</title>
      <description>
        <![CDATA[U.S. Health and Human Services Secretary Robert Kennedy is facing a second lawsuit challenging his replacement of all the members of the Advisory Committee on Immunization Practices (ACIP) and seeking to undo the CDC’s Jan. 5 revision of its childhood immunization schedule.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729203</guid>
      <pubDate>Wed, 25 Feb 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/729203-another-lawsuit-challenges-changes-to-acip-us-vaccine-schedule</link>
    </item>
    <item>
      <title>US Fed Circuit protects 101 passage for some gene therapy patents</title>
      <description>
        <![CDATA[In handing a win to Regenxbio Inc., the U.S. Court of Appeals for the Federal Circuit also cleared some leaves from the 101 patent eligibility threshold after years of Supreme Court decisions cluttering the passageway.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729195</guid>
      <pubDate>Tue, 24 Feb 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/729195-us-fed-circuit-protects-101-passage-for-some-gene-therapy-patents</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Patent-wheels.webp?t=1588870185" type="image/png" medium="image" fileSize="648858">
        <media:title type="plain">Patent gears</media:title>
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    <item>
      <title>Tariffs nixed by Supreme Court, Trump still has options </title>
      <description>
        <![CDATA[U.S. President Donald Trump’s foreign-imports tariff policies did not hold up well at the Supreme Court, which ruled unconstitutional his edicts under the International Emergency Economic Powers Act. The sharply worded 6-3 opinion was authored by Chief Justice John Roberts.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729098</guid>
      <pubDate>Fri, 20 Feb 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/729098-tariffs-nixed-by-supreme-court-trump-still-has-options</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/US-flag-gavel-book.webp?t=1719870359" type="image/jpeg" medium="image" fileSize="164532">
        <media:title type="plain">US flag, gavel, book</media:title>
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      <title>Abbvie claims CMS’ selection of Botox violates the IRA </title>
      <description>
        <![CDATA[Undeterred by all the unsuccessful biopharma suits challenging the U.S. Medicare price negotiations, Abbvie Inc. filed its own complaint Feb. 11 in the U.S. District Court for the District of Columbia, seeking to undo CMS’ selection of Botox in the third round of the negotiations.]]>
      </description>
      <guid>http://www.bioworld.com/articles/728987</guid>
      <pubDate>Thu, 12 Feb 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728987-abbvie-claims-cms-selection-of-botox-violates-the-ira</link>
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    <item>
      <title>Medtronic to pay Applied Medical $382M in antitrust ruling</title>
      <description>
        <![CDATA[A jury in a U.S. District Court unanimously found that Medtronic plc violated federal and state antitrust laws relating to its blood sealing surgical devices and must pay $382 million in damages to Applied Medical Resources Corp.]]>
      </description>
      <guid>http://www.bioworld.com/articles/728661</guid>
      <pubDate>Fri, 06 Feb 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728661-medtronic-to-pay-applied-medical-382m-in-antitrust-ruling</link>
    </item>
    <item>
      <title>Former Cytodyn CEO faces prison time, millions in restitution</title>
      <description>
        <![CDATA[Nader Pourhassan, the former president and CEO of Cytodyn Inc., was sentenced Jan. 23 to 30 months in prison for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab as a treatment for HIV and COVID-19.]]>
      </description>
      <guid>http://www.bioworld.com/articles/728505</guid>
      <pubDate>Tue, 27 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728505-former-cytodyn-ceo-faces-prison-time-millions-in-restitution</link>
    </item>
    <item>
      <title>Drug, device makers could still be liable for terrorist attacks</title>
      <description>
        <![CDATA[In a lawsuit that’s been bouncing through the courts for years, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for terrorist attacks against hundreds of Americans in Iraq.]]>
      </description>
      <guid>http://www.bioworld.com/articles/728316</guid>
      <pubDate>Mon, 26 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728316-drug-device-makers-could-still-be-liable-for-terrorist-attacks</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Gavel-and-scales.webp?t=1623104173" type="image/png" medium="image" fileSize="459654">
        <media:title type="plain">Gavel and scales</media:title>
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      <title>Zynex officials indicted for health care fraud</title>
      <description>
        <![CDATA[The U.S. Department of Justice reported that it has indicted two executives with Zynex Inc. for Medicare fraud, but in one of the stranger twists in recent fraud cases, one of the executives allegedly attempted to interfere with the personal lives of members of the media who were reporting on the company’s legal problems.]]>
      </description>
      <guid>http://www.bioworld.com/articles/728242</guid>
      <pubDate>Mon, 26 Jan 2026 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728242-zynex-officials-indicted-for-health-care-fraud</link>
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        <media:title type="plain">Decorative scales of justice in a courtroom</media:title>
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      <title>Skinny labeling to get its day before the US Supreme Court</title>
      <description>
        <![CDATA[After passing on one skinny label case a few years ago, the U.S. Supreme Court agreed to delve into the dark hole the Federal Circuit has dug for drug label carveouts that allow generic drugs and biosimilars to come to market even though some indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert Jan. 16 to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl).]]>
      </description>
      <guid>http://www.bioworld.com/articles/728135</guid>
      <pubDate>Tue, 20 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728135-skinny-labeling-to-get-its-day-before-the-us-supreme-court</link>
    </item>
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      <title>FY 2025 a banner year for US False Claims Act recoveries</title>
      <description>
        <![CDATA[The U.S. Department of Justice said recoveries under the False Claims Act in fiscal year 2025 reached a record of more than $6.8 billion, more than 80% of which came from health care cases.]]>
      </description>
      <guid>http://www.bioworld.com/articles/728053</guid>
      <pubDate>Tue, 20 Jan 2026 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728053-fy-2025-a-banner-year-for-us-false-claims-act-recoveries</link>
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        <media:title type="plain">Decorative scales of justice in a courtroom</media:title>
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    <item>
      <title>Biopharma consultant charged with insider trading </title>
      <description>
        <![CDATA[A biostatistician who was consulting for C4 Therapeutics Inc. is facing civil and criminal charges of U.S. securities fraud related to insider trading that allegedly produced nearly $500,000 in profit.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727996</guid>
      <pubDate>Thu, 15 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727996-biopharma-consultant-charged-with-insider-trading</link>
    </item>
    <item>
      <title>ACIP expands again, but no new infectious disease experts added </title>
      <description>
        <![CDATA[U.S. Health and Human Services Secretary Robert Kennedy has once again expanded the CDC’s Advisory Committee on Immunization Practices (ACIP), this time adding two more ob-gyns to the membership list.&nbsp;<span style=" font-style: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; widows: 2; word-spacing: 0px; display: inline !important; float: none;">As a result, the ACIP, which can have up to 19 members, now numbers 13, three of whom are ob-gyns.</span>]]>
      </description>
      <guid>http://www.bioworld.com/articles/727882</guid>
      <pubDate>Tue, 13 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727882-acip-expands-again-but-no-new-infectious-disease-experts-added</link>
    </item>
    <item>
      <title>Appeals court says no to cap on indirect costs in NIH grants</title>
      <description>
        <![CDATA[Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727863</guid>
      <pubDate>Thu, 08 Jan 2026 09:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727863-appeals-court-says-no-to-cap-on-indirect-costs-in-nih-grants</link>
    </item>
    <item>
      <title>Industry considering options amid US vaccine upheaval</title>
      <description>
        <![CDATA[The chaos Health and Human Services Secretary Robert Kennedy has injected into the U.S. vaccine market could have long-term consequences as vaccine makers reevaluate business decisions and pipelines.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727707</guid>
      <pubDate>Wed, 07 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727707-industry-considering-options-amid-us-vaccine-upheaval</link>
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        <media:title type="plain">U.S. vaccine illustration</media:title>
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      <title>Appeals court says no to cap on indirect costs in NIH grants</title>
      <description>
        <![CDATA[Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727784</guid>
      <pubDate>Tue, 06 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727784-appeals-court-says-no-to-cap-on-indirect-costs-in-nih-grants</link>
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