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      <title>China gives nod to Innovent’s limertinib NDA for lung cancer</title>
      <description>
        <![CDATA[China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.]]>
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      <guid>http://www.bioworld.com/articles/716556</guid>
      <pubDate>Tue, 21 Jan 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/716556-china-gives-nod-to-innovents-limertinib-nda-for-lung-cancer</link>
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      <title>China gives nod to Innovent’s limertinib NDA for lung cancer</title>
      <description>
        <![CDATA[China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.]]>
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      <guid>http://www.bioworld.com/articles/716384</guid>
      <pubDate>Fri, 17 Jan 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/716384-china-gives-nod-to-innovents-limertinib-nda-for-lung-cancer</link>
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      <title>FDA clears Vuno’s AI-based MRI reading software for early Alzheimer’s detection</title>
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        <![CDATA[Vuno Inc. gained a U.S. FDA’s 510(k) clearance for its artificial intelligence (AI)-powered brain quantification device, Vuno Med-Deepbrain, to diagnose possible dementia in patients “even before mild cognitive impairment.”]]>
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      <guid>http://www.bioworld.com/articles/702037</guid>
      <pubDate>Wed, 25 Oct 2023 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/702037-fda-clears-vunos-ai-based-mri-reading-software-for-early-alzheimers-detection</link>
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        <media:title type="plain">Vuno</media:title>
        <media:description type="plain">Vuno’s Med-Deepbrain. Credit: Vuno Inc.</media:description>
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      <title>China approves two more CAR T trials; Legend’s candidate gets FDA breakthrough status</title>
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        <![CDATA[BEIJING – China made strides in the CAR T space this month. The country approved two more candidates to enter clinical trials in December, and forerunner Nanjing Legend Biotech Co. Ltd. said its investigational CAR T therapy LCAR-B38M/JNJ-4528 co-developed with Janssen Biotech Inc. won FDA’s breakthrough therapy designation.]]>
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      <guid>http://www.bioworld.com/articles/432010</guid>
      <pubDate>Tue, 24 Dec 2019 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/432010-china-approves-two-more-car-t-trials-legends-candidate-gets-fda-breakthrough-status</link>
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        <media:title type="plain">Stem cells</media:title>
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      <title>China approves two more CAR T trials; Legend’s candidate gets FDA breakthrough status</title>
      <description>
        <![CDATA[BEIJING – China made strides in the CAR T space this month. The country approved two more candidates to enter clinical trials in December, and forerunner Nanjing Legend Biotech Co. Ltd. said its investigational CAR T therapy LCAR-B38M/JNJ-4528 co-developed with Janssen Biotech Inc. won FDA’s breakthrough therapy designation.]]>
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      <guid>http://www.bioworld.com/articles/431963</guid>
      <pubDate>Fri, 20 Dec 2019 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/431963-china-approves-two-more-car-t-trials-legends-candidate-gets-fda-breakthrough-status</link>
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      <title>Analysis by U.K. startup Medbelle highlights extent of drug pricing disparity</title>
      <description>
        <![CDATA[LONDON &ndash; It&rsquo;s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines in 50 countries worldwide.]]>
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      <guid>http://www.bioworld.com/articles/431381</guid>
      <pubDate>Tue, 26 Nov 2019 11:30:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/431381-analysis-by-uk-startup-medbelle-highlights-extent-of-drug-pricing-disparity</link>
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        <media:title type="plain">World map made of pills</media:title>
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      <title>Analysis by U.K. startup Medbelle highlights extent of drug pricing disparity</title>
      <description>
        <![CDATA[LONDON &ndash; It&rsquo;s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines in 50 countries worldwide. For all but one of the 13, the U.S. price is the highest. ]]>
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      <guid>http://www.bioworld.com/articles/431290</guid>
      <pubDate>Thu, 21 Nov 2019 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/431290-analysis-by-uk-startup-medbelle-highlights-extent-of-drug-pricing-disparity</link>
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        <media:title type="plain">World map made of pills</media:title>
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      <title>Courts split on DoJ authority to dismiss False Claims Act cases</title>
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        <![CDATA[The U.S. Department of Justice (DoJ) has taken action to tamp down on False Claims Act (FCA) lawsuits. However, according to attorneys with the law firm of Gibson, Dunn & Crutcher LLP, the courts have come to different conclusions as to whether federal attorneys have appropriately dismissed FCA cases, a development that opens a new area of concern for drug and device makers.]]>
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      <guid>http://www.bioworld.com/articles/430430</guid>
      <pubDate>Wed, 16 Oct 2019 00:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/430430-courts-split-on-doj-authority-to-dismiss-false-claims-act-cases</link>
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      <title>3Q deals and M&amp;A: Volumes down, values up; 2019 already topping last two years</title>
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        <![CDATA[The number of biopharma deals and mergers and acquisitions completed are on a downward slide quarter-by-quarter, although when taken as a whole, the industry in 2019 has completed as many transactions and is hitting a higher deal value than the year before, while M&A values are up by 32%.]]>
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      <guid>http://www.bioworld.com/articles/429235</guid>
      <pubDate>Mon, 14 Oct 2019 00:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/429235-3q-deals-and-m-a-volumes-down-values-up-2019-already-topping-last-two-years</link>
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      <title>Solid quarter for sector's global public and private financings</title>
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        <![CDATA[In the third quarter, global biopharmaceutical companies collectively raised more than $12 billion from public and private transactions. Year to date (YTD), the sector has generated $41.5 billion, according to BioWorld data, putting it on track for a $55 billion haul for the year.]]>
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      <guid>http://www.bioworld.com/articles/429244</guid>
      <pubDate>Mon, 07 Oct 2019 00:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/429244-solid-quarter-for-sectors-global-public-and-private-financings</link>
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      <title>Brexit-shaped hole in U.K.'s Q3 funding for life sciences</title>
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        <![CDATA[LONDON - The Brexit factor appears to be holding back fundraising across all sectors in the U.K., and life sciences is no exception. After a small pick-up in the second quarter, the third quarter has disappointed, with £214 million (US$263.2 million) raised by U.K. biotechs across the public and private markets.]]>
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      <guid>http://www.bioworld.com/articles/429588</guid>
      <pubDate>Thu, 03 Oct 2019 00:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/429588-brexit-shaped-hole-in-uks-q3-funding-for-life-sciences</link>
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      <title>Great Danes push YTD funding tally to $5.6B as European biotech raises $2.4B in Q3</title>
      <description>
        <![CDATA[DUBLIN – European biotechnology firms engaged in the discovery and development of drugs and other therapeutic modalities raised $2.366 billion in equity financing during the third quarter, taking the running total for the year so far to $5.570 billion.]]>
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      <guid>http://www.bioworld.com/articles/429587</guid>
      <pubDate>Thu, 03 Oct 2019 00:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/429587-great-danes-push-ytd-funding-tally-to-5-6b-as-european-biotech-raises-2-4b-in-q3</link>
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      <title>South Korea's Samsung Bioepis  to provide Enbrel biosimilar to Brazil market</title>
      <description>
        <![CDATA[HONG KONG – South Korean biopharmaceutical company Samsung Bioepis Co. Ltd., based in Incheon, will expand into the Brazilian market with Brenzys (etanercept), having recently signed a marketing agreement with Brazil's Ministry of Health. The drug is now available through the country's public health system, Sistema Único de Saùde (SUS).]]>
      </description>
      <guid>http://www.bioworld.com/articles/429331</guid>
      <pubDate>Mon, 16 Sep 2019 00:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/429331-south-koreas-samsung-bioepis-to-provide-enbrel-biosimilar-to-brazil-market</link>
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      <title>Germany HTA analysis points out lack of sufficient benefit data for newly approved drugs</title>
      <description>
        <![CDATA[LONDON - More than half of the 216 newly approved drugs reviewed by Germany's health technology assessment (HTA) agency between 2011 and 2017 did not have evidence to show they provided benefit over the existing standard of care.]]>
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      <guid>http://www.bioworld.com/articles/347403</guid>
      <pubDate>Fri, 12 Jul 2019 00:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/347403-germany-hta-analysis-points-out-lack-of-sufficient-benefit-data-for-newly-approved-drugs</link>
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