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      <title>Sinocelltech receives first NMPA approval for a homegrown anti-CD20 MAb </title>
      <description>
        <![CDATA[Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile.]]>
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      <guid>http://www.bioworld.com/articles/689357</guid>
      <pubDate>Tue, 06 Sep 2022 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/689357-sinocelltech-receives-first-nmpa-approval-for-a-homegrown-anti-cd20-mab</link>
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    <item>
      <title>Sinocelltech receives first NMPA approval for a homegrown anti-CD20 MAb </title>
      <description>
        <![CDATA[Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile.]]>
      </description>
      <guid>http://www.bioworld.com/articles/672662</guid>
      <pubDate>Thu, 01 Sep 2022 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/672662-sinocelltech-receives-first-nmpa-approval-for-a-homegrown-anti-cd20-mab</link>
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    <item>
      <title>US FDA final guidances part of cancer moonshot payload</title>
      <description>
        <![CDATA[Ahead of U.S. President Joe Biden’s State of the Union address March 1 in which he gave a shoutout to his cancer moonshot initiative, the FDA released a trio of final guidances aimed at speeding the development of new cancer drugs. First launched in 2016 with the goal of doubling the rate of progress against cancer by making a decade worth of advances in five years, the moonshot was reignited last month with a new target following setbacks in cancer screenings and treatments during the COVID-19 pandemic. Now, Biden’s catch phrase is “ending cancer as we know it.”]]>
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      <guid>http://www.bioworld.com/articles/516588</guid>
      <pubDate>Wed, 02 Mar 2022 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/516588-us-fda-final-guidances-part-of-cancer-moonshot-payload</link>
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        <media:description type="plain">Credit: Postmodern Studio - stock.adobe.com</media:description>
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      <title>Regulatory front for April 30, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS tacks three years onto CJR, revises target price calculation; Connect for Health Act back in play; More bezel troubles for Alaris 8100; CMS announces two meetings for FY 2022 lab fee schedule.]]>
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      <guid>http://www.bioworld.com/articles/506600</guid>
      <pubDate>Fri, 30 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506600-regulatory-front-for-april-30-2021</link>
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      <title>Regulatory front for April 28, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Task force affirms hypertension screening recommendation; FDA adds to list of recognized standards; New Jersey DOJ office announces $93M fraud take-down.]]>
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      <guid>http://www.bioworld.com/articles/506488</guid>
      <pubDate>Wed, 28 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506488-regulatory-front-for-april-28-2021</link>
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    <item>
      <title>Regulatory front for April 27, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO denies Roche challenge of Air Force request; NICE updates atrial fibrillation guidelines.]]>
      </description>
      <guid>http://www.bioworld.com/articles/506434</guid>
      <pubDate>Tue, 27 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506434-regulatory-front-for-april-27-2021</link>
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      <title>Regulatory front for April 26, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: PTAB rejects 3Shape&rsquo;s attempt to invalidate claims for Align patent.]]>
      </description>
      <guid>http://www.bioworld.com/articles/506371</guid>
      <pubDate>Mon, 26 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506371-regulatory-front-for-april-26-2021</link>
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      <title>Regulatory front for April 23, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Alivecor goes to ITC in patent scrum with Apple; Cordis carotid artery stent recalled; C-Rad snares court win for patent; Orthotics supplies subject of $65M in fraud.]]>
      </description>
      <guid>http://www.bioworld.com/articles/506277</guid>
      <pubDate>Fri, 23 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506277-regulatory-front-for-april-23-2021</link>
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      <title>Regulatory front for April 21, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPSTF sees no reason to recommend screening for AF; Two senators press for UDI data in Medicare claims; Medtronic blood pump console recalled; Federal Circuit affirms PTAB in Cerner/Clinicomp patent dispute.]]>
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      <guid>http://www.bioworld.com/articles/506218</guid>
      <pubDate>Wed, 21 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506218-regulatory-front-for-april-21-2021</link>
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    <item>
      <title>Regulatory front for April 20, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Central Drugs Standard Control Organization, World Health Organization.]]>
      </description>
      <guid>http://www.bioworld.com/articles/506104</guid>
      <pubDate>Tue, 20 Apr 2021 12:05:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506104-regulatory-front-for-april-20-2021</link>
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        <media:title type="plain">Architectural pillars</media:title>
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      <title>Regulatory front for April 20, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA provides path for diagnostic testing using pooled samples; FDA inks warnings for pandemic testing; Recall issued for repaired infusion pumps; NICE launches transformative strategy; NICE launches transformative strategy; Russia expands access to certain pediatric treatments.]]>
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      <guid>http://www.bioworld.com/articles/506166</guid>
      <pubDate>Tue, 20 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506166-regulatory-front-for-april-20-2021</link>
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    <item>
      <title>Regulatory front for April 19, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD Alaris pumps recalled over keypad problems.]]>
      </description>
      <guid>http://www.bioworld.com/articles/506099</guid>
      <pubDate>Mon, 19 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506099-regulatory-front-for-april-19-2021</link>
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    <item>
      <title>Regulatory front for April 16, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA says backlog of non-COVID applications will be cleared in eight weeks; NIH awards $33M for return-to-school efforts; Advamed tells CMS not to delay on MCIT.]]>
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      <guid>http://www.bioworld.com/articles/506043</guid>
      <pubDate>Fri, 16 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506043-regulatory-front-for-april-16-2021</link>
    </item>
    <item>
      <title>Regulatory front for April 16, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting biopharma.]]>
      </description>
      <guid>http://www.bioworld.com/articles/506020</guid>
      <pubDate>Fri, 16 Apr 2021 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/506020-regulatory-front-for-april-16-2021</link>
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    <item>
      <title>Regulatory front for April 15, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA reverses HHS premarket notification exemptions; ITC will check findings for Zimmer/Heraeus dispute.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505987</guid>
      <pubDate>Thu, 15 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505987-regulatory-front-for-april-15-2021</link>
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    <item>
      <title>Regulatory front for April 14, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS may reverse non-coverage for catheter pulmonary embolectomy.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505943</guid>
      <pubDate>Wed, 14 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505943-regulatory-front-for-april-14-2021</link>
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    <item>
      <title>Regulatory front for April 13, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting biopharma in Asia, including: EC, NIAID.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505864</guid>
      <pubDate>Tue, 13 Apr 2021 12:28:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505864-regulatory-front-for-april-13-2021</link>
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        <media:title type="plain">Architectural pillars</media:title>
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      <title>Regulatory front for April 13, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE needs more evidence for Clarity RMS for AKI; Thermacor disposable sets recalled.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505896</guid>
      <pubDate>Tue, 13 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505896-regulatory-front-for-april-13-2021</link>
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    <item>
      <title>Regulatory front for April 12, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Medtronic recalls electrophysiology units over battery depletion; ASCA labs listed by FDA.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505812</guid>
      <pubDate>Mon, 12 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505812-regulatory-front-for-april-12-2021</link>
    </item>
    <item>
      <title>Regulatory front for April 9, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS, DOJ officials highlight pandemic response needs; FDA says plenty of respirators available; NICE supports use of Danis for variceal hemorrhage.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505761</guid>
      <pubDate>Fri, 09 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505761-regulatory-front-for-april-9-2021</link>
    </item>
    <item>
      <title>Regulatory front for April 8, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FCC says no need to revisit telehealth grants; NICE updates sphere usage for hepatocellular carcinoma; Health Canada: Docs, nurses not needed for workplace testing.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505705</guid>
      <pubDate>Thu, 08 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505705-regulatory-front-for-april-8-2021</link>
    </item>
    <item>
      <title>Regulatory front for April 7, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals&rsquo; review of lower court decision; Industry, docs push back on prior authorization.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505654</guid>
      <pubDate>Wed, 07 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505654-regulatory-front-for-april-7-2021</link>
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    <item>
      <title>Regulatory front for April 6, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA adds fingerstick sample to roster of COVID EUAs; NICE: Sonata system not backed by head-to-head studies.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505602</guid>
      <pubDate>Tue, 06 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505602-regulatory-front-for-april-6-2021</link>
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    <item>
      <title>Regulatory front for April 6, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Global Health Innovative Technology Fund, Health Canada, Therapeutic Goods Administration.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505540</guid>
      <pubDate>Tue, 06 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505540-regulatory-front-for-april-6-2021</link>
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        <media:title type="plain">Architectural pillars</media:title>
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    <item>
      <title>Regulatory front for April 5, 2021</title>
      <author>holland.johnson@clarivate.com</author>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: COVID-19 inventions included in USPTO awards program; First thrombosis incident reported in Australia; FDA revises Moderna EUA; GAO refuses to reconsider VA challenge.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505535</guid>
      <pubDate>Mon, 05 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505535-regulatory-front-for-april-5-2021</link>
    </item>
    <item>
      <title>Regulatory front for April 2, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Infections associated with reprocessed urological endoscopes under investigation.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505501</guid>
      <pubDate>Fri, 02 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505501-regulatory-front-for-april-2-2021</link>
    </item>
    <item>
      <title>Regulatory front for April 1, 2021</title>
      <author>holland.johnson@clarivate.com</author>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MDIC accepting applications for the ASC pilot study.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505486</guid>
      <pubDate>Thu, 01 Apr 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505486-regulatory-front-for-april-1-2021</link>
    </item>
    <item>
      <title>Regulatory front for March 31, 2021</title>
      <author>holland.johnson@clarivate.com</author>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warns about differing complication rates for acellular dermal matrix; CDC and NIH initiate COVID-19 self-testing pilot program; GHIT invests $21M; MHRA updates guidance.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505433</guid>
      <pubDate>Wed, 31 Mar 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505433-regulatory-front-for-march-31-2021</link>
    </item>
    <item>
      <title>Regulatory front for March 30, 2021</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Gamaleya Institute, Therapeutic Goods Administration.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505314</guid>
      <pubDate>Tue, 30 Mar 2021 12:11:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505314-regulatory-front-for-march-30-2021</link>
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        <media:title type="plain">Architectural pillars</media:title>
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    <item>
      <title>Regulatory front for March 30, 2021</title>
      <author>holland.johnson@clarivate.com</author>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, other stent graft products in line for FDA panel safety probe; New conditions imposed on vaccine authorization; MRNA vaccine efficacy holds in real world; STIs on the rise in U.S.]]>
      </description>
      <guid>http://www.bioworld.com/articles/505376</guid>
      <pubDate>Tue, 30 Mar 2021 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/505376-regulatory-front-for-march-30-2021</link>
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