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<feedburner:origLink>https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilar-streamlining-takes-a-further-step-forward-in-europe-LEIIFCCRP5FLBL3VLIXML4KMSQ/</feedburner:origLink><title><![CDATA[Biosimilar Streamlining Takes A Further Step Forward In Europe ]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/953180381/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/953180381/0/pink~Biosimilar-Streamlining-Takes-A-Further-Step-Forward-In-Europe/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilar-streamlining-takes-a-further-step-forward-in-europe-LEIIFCCRP5FLBL3VLIXML4KMSQ/</guid><dc:creator><![CDATA[Dave Wallace]]></dc:creator><description><![CDATA[Marking the latest definite step towards a streamlined regulatory pathway for biosimilars as standard, the European Medicines Agency has formally adopted its reflection paper on a tailored clinical approach in biosimilar development.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/C-kDWasJ-L1HGRfgeEdrX5i4ufs=/cloudfront-us-east-1.images.arcpublishing.com/norstella/GGWTS7PAONOYDEX24WQYHJDXGI.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/C-kDWasJ-L1HGRfgeEdrX5i4ufs=/cloudfront-us-east-1.images.arcpublishing.com/norstella/GGWTS7PAONOYDEX24WQYHJDXGI.jpg"/></a></div>
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</description><pubDate>Fri, 03 Apr 2026 15:00:00 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/C-kDWasJ-L1HGRfgeEdrX5i4ufs=/cloudfront-us-east-1.images.arcpublishing.com/norstella/GGWTS7PAONOYDEX24WQYHJDXGI.jpg" type="image/jpeg" height="675" width="1200"><media:description type="plain"><![CDATA[The EMA has formally adopted its reflection paper on biosimilar streamlining]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/market-access/pricing-debate/us-mfn-policies-are-driving-the-need-for-better-rwe-RJHXUNM7ONGKPLXWL7NRYT6QDM/</feedburner:origLink><title><![CDATA[US MFN Policies Are Driving The Need For Better RWE]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/953063606/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/953063606/0/pink~US-MFN-Policies-Are-Driving-The-Need-For-Better-RWE/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/market-access/pricing-debate/us-mfn-policies-are-driving-the-need-for-better-rwe-RJHXUNM7ONGKPLXWL7NRYT6QDM/</guid><dc:creator><![CDATA[Francesca Bruce]]></dc:creator><description><![CDATA[Early engagement with patients in designing longitudinal studies will produce meaningful results. <div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/LFHAQkfynwSIQmWgJmxzRqB_Aek=/cloudfront-us-east-1.images.arcpublishing.com/norstella/D7QL477D3VD7BNOJMAZKBWAFL4.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/LFHAQkfynwSIQmWgJmxzRqB_Aek=/cloudfront-us-east-1.images.arcpublishing.com/norstella/D7QL477D3VD7BNOJMAZKBWAFL4.jpg"/></a></div>
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</description><pubDate>Thu, 02 Apr 2026 13:51:18 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/LFHAQkfynwSIQmWgJmxzRqB_Aek=/cloudfront-us-east-1.images.arcpublishing.com/norstella/D7QL477D3VD7BNOJMAZKBWAFL4.jpg" type="image/jpeg" height="675" width="1200"><media:description type="plain"><![CDATA[Engaging early with patients can improve real-world evidence generation.]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/real-world-evidence/ema-explains-how-to-assess-quality-of-rwd-used-in-regulatory-submissions-IXY3AK4JZZD3ZOUJVGDF4MVIMQ/</feedburner:origLink><title><![CDATA[EMA Explains How To Assess Quality Of RWD Used In Regulatory Submissions]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/953064776/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/953064776/0/pink~EMA-Explains-How-To-Assess-Quality-Of-RWD-Used-In-Regulatory-Submissions/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/real-world-evidence/ema-explains-how-to-assess-quality-of-rwd-used-in-regulatory-submissions-IXY3AK4JZZD3ZOUJVGDF4MVIMQ/</guid><dc:creator><![CDATA[Neena Brizmohun]]></dc:creator><description><![CDATA[The European Medicines Agency says its new guidance offers actionable and focused recommendations for assessing the data quality of real-world data, with the aim of enhancing the usefulness of real-world evidence for regulatory purposes.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/Ip8RIe2B6vfYQ0cZmTmO3_Hvz_g=/cloudfront-us-east-1.images.arcpublishing.com/norstella/ZNRCT3XOQRAXDND5EIDZMRIDNY.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/Ip8RIe2B6vfYQ0cZmTmO3_Hvz_g=/cloudfront-us-east-1.images.arcpublishing.com/norstella/ZNRCT3XOQRAXDND5EIDZMRIDNY.jpg"/></a></div>
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</description><pubDate>Thu, 02 Apr 2026 13:40:45 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/Ip8RIe2B6vfYQ0cZmTmO3_Hvz_g=/cloudfront-us-east-1.images.arcpublishing.com/norstella/ZNRCT3XOQRAXDND5EIDZMRIDNY.jpg" type="image/jpeg" height="500" width="1000"><media:description type="plain"><![CDATA[New EU guidance aims to strengthen data quality assurance for RWD]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/product-reviews/approvals/us-fda-approval-output-still-not-showing-impact-of-departures-BKN4Y5NWYZDFFD64PTPPF3RLQE/</feedburner:origLink><title><![CDATA[US FDA Approval Output Still Not Showing Impact Of Departures]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/953111636/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/953111636/0/pink~US-FDA-Approval-Output-Still-Not-Showing-Impact-Of-Departures/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/product-reviews/approvals/us-fda-approval-output-still-not-showing-impact-of-departures-BKN4Y5NWYZDFFD64PTPPF3RLQE/</guid><dc:creator><![CDATA[Derrick Gingery]]></dc:creator><description><![CDATA[Stakeholders warned that FDA application approval volume may be impacted by the widespread loss of staff, although the most recent data remains relatively consistent with previous years.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/ryTlR5XxEeA83LhLDNV9lt7lRgI=/cloudfront-us-east-1.images.arcpublishing.com/norstella/IUVCWFNNOZF33IOO3GY3OR2NTY.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/ryTlR5XxEeA83LhLDNV9lt7lRgI=/cloudfront-us-east-1.images.arcpublishing.com/norstella/IUVCWFNNOZF33IOO3GY3OR2NTY.jpg"/></a></div>
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</description><pubDate>Thu, 02 Apr 2026 20:00:56 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/ryTlR5XxEeA83LhLDNV9lt7lRgI=/cloudfront-us-east-1.images.arcpublishing.com/norstella/IUVCWFNNOZF33IOO3GY3OR2NTY.jpg" type="image/jpeg" height="667" width="1000"><media:description type="plain"><![CDATA[Brand and generic drug approval volume has remained resilient in the face of widespread departures.]]></media:description></media:content></item>
<item>
<feedburner:origLink>https://insights.citeline.com/pink-sheet/market-access/government-payers/medicare/most-favored-nation-pricing-deals-demos-complicate-medicare-negotiation-prospects-T5CY44662NCBLCAQBHOZAEG5W4/</feedburner:origLink><title><![CDATA[Most Favored Nation Pricing Deals, Demos Complicate Medicare Negotiation Prospects]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/953111639/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/953111639/0/pink~Most-Favored-Nation-Pricing-Deals-Demos-Complicate-Medicare-Negotiation-Prospects/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/market-access/government-payers/medicare/most-favored-nation-pricing-deals-demos-complicate-medicare-negotiation-prospects-T5CY44662NCBLCAQBHOZAEG5W4/</guid><dc:creator><![CDATA[Cathy Kelly]]></dc:creator><description><![CDATA[Drug pricing policy experts look at what’s ahead for the Medicare negotiation program and what lessons can be drawn from the past two cycles.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/1LBy2W4POv8hvqrhKDXdbEYz98A=/cloudfront-us-east-1.images.arcpublishing.com/norstella/LU54HEVOBVDNDGROUYUC2TNWFI.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/1LBy2W4POv8hvqrhKDXdbEYz98A=/cloudfront-us-east-1.images.arcpublishing.com/norstella/LU54HEVOBVDNDGROUYUC2TNWFI.jpg"/></a></div>
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</description><pubDate>Thu, 02 Apr 2026 19:59:56 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/1LBy2W4POv8hvqrhKDXdbEYz98A=/cloudfront-us-east-1.images.arcpublishing.com/norstella/LU54HEVOBVDNDGROUYUC2TNWFI.jpg" type="image/jpeg" height="667" width="1000"><media:description type="plain"><![CDATA[Changes could be coming from direct and indirect actions by the Trump Administration.]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/policy-regulation/trump-100-tariffs-on-drugs-make-big-pharmas-negotiations-a-smart-play-LRD4YH2BYBH6LNVDMGHJDABJXY/</feedburner:origLink><title><![CDATA[Trump 100% Tariffs On Drugs Make Big Pharma’s Negotiations A Smart Play]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/953124626/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/953124626/0/pink~Trump-Tariffs-On-Drugs-Make-Big-Pharma%e2%80%99s-Negotiations-A-Smart-Play/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/policy-regulation/trump-100-tariffs-on-drugs-make-big-pharmas-negotiations-a-smart-play-LRD4YH2BYBH6LNVDMGHJDABJXY/</guid><dc:creator><![CDATA[Jessica Merrill]]></dc:creator><description><![CDATA[Most big pharmas – the companies that tend to have a global manufacturing network – are exempt from the US government’s Section 232 tariffs on pharmaceuticals. <div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/4frB0frUOceiIp_pz4CA0t42xR8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/P4N2H3K6PNBQZARBE6GBKDABIU.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/4frB0frUOceiIp_pz4CA0t42xR8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/P4N2H3K6PNBQZARBE6GBKDABIU.jpg"/></a></div>
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</description><pubDate>Thu, 02 Apr 2026 22:45:25 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/4frB0frUOceiIp_pz4CA0t42xR8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/P4N2H3K6PNBQZARBE6GBKDABIU.jpg" type="image/jpeg" height="3810" width="5480"/></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/product-reviews/the-one-day-fda-us-commissioner-sees-drastic-time-savings-in-filing-inspections-C47F4N6AGVF2POUY736HO4EJA4/</feedburner:origLink><title><![CDATA[The One-Day FDA: US Commissioner Sees Drastic Time Savings In Filing, Inspections ]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/952901579/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/952901579/0/pink~The-OneDay-FDA-US-Commissioner-Sees-Drastic-Time-Savings-In-Filing-Inspections/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/product-reviews/the-one-day-fda-us-commissioner-sees-drastic-time-savings-in-filing-inspections-C47F4N6AGVF2POUY736HO4EJA4/</guid><dc:creator><![CDATA[Bridget Silverman]]></dc:creator><description><![CDATA[FDA Commissioner Makary's efficiency targets feature plans to shrink the agency's 60 day filing review to minutes while one-day facility inspections replace weeks-long visits.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/SnV85uA_zqQzCFsY7YKsv1HGZMY=/cloudfront-us-east-1.images.arcpublishing.com/norstella/3MIHNOBYJRHE5D3O7UBMENU7M4.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/SnV85uA_zqQzCFsY7YKsv1HGZMY=/cloudfront-us-east-1.images.arcpublishing.com/norstella/3MIHNOBYJRHE5D3O7UBMENU7M4.jpg"/></a></div>
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</description><pubDate>Wed, 01 Apr 2026 23:09:57 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/SnV85uA_zqQzCFsY7YKsv1HGZMY=/cloudfront-us-east-1.images.arcpublishing.com/norstella/3MIHNOBYJRHE5D3O7UBMENU7M4.jpg" type="image/jpeg" height="3240" width="8000"><media:description type="plain"><![CDATA[The US FDA is aiming for record fast drug reviews by finding efficiencies]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/product-reviews/approvals/fda-says-lillys-foundayo-approved-in-record-time-UFYP74YBLBCITHV3V3FCZCAGZQ/</feedburner:origLink><title><![CDATA[FDA Says Lilly’s Foundayo Approved In Record Time ]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/952865087/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/952865087/0/pink~FDA-Says-Lilly%e2%80%99s-Foundayo-Approved-In-Record-Time/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/product-reviews/approvals/fda-says-lillys-foundayo-approved-in-record-time-UFYP74YBLBCITHV3V3FCZCAGZQ/</guid><dc:creator><![CDATA[Alaric DeArment, Mary Jo Laffler]]></dc:creator><description><![CDATA[The hotly anticipated approval of orforglipron for obesity came through in record time, with the company planning to start shipping it on April 6. <div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/KSn-C3Jf3CKjy5W828N3aEbFTeU=/cloudfront-us-east-1.images.arcpublishing.com/norstella/DQHQ5QZ5W5FEBHA5ZPVONSXMH4.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/KSn-C3Jf3CKjy5W828N3aEbFTeU=/cloudfront-us-east-1.images.arcpublishing.com/norstella/DQHQ5QZ5W5FEBHA5ZPVONSXMH4.jpg"/></a></div>
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</description><pubDate>Wed, 01 Apr 2026 20:35:09 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/KSn-C3Jf3CKjy5W828N3aEbFTeU=/cloudfront-us-east-1.images.arcpublishing.com/norstella/DQHQ5QZ5W5FEBHA5ZPVONSXMH4.jpg" type="image/jpeg" height="667" width="1000"><media:description type="plain"><![CDATA[Lilly received FDA approval for Foundayo, setting up competition with Novo Nordisk's oral version of Wegovy.]]></media:description></media:content></item>
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