Endpoints News — FDA launches rare disease hub; Novavax hit with clinical hold

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font:700 14px/23px Roboto, Arial, Helvetica, sans-serif;"> <span >1</span>. <td width="5" style="font-size:1px; line-height:1px;"></td><td style="padding:10px 0; color:#2281D5; border-bottom:1px solid #E0E0E0; mso-ascii-font-family:Georgia, serif; font:16px/22px Merriweather, Georgia, serif;"> <a target="_blank" style="color:#2281D5; text-decoration:none;" href="https://endpts.com/aa/IAAS12N2UFCLJHQ7/" title="FDA leaders kick off rare disease hub to increase cross-center collaboration" data-at="r" data-aid="M+R2eUbg"> FDA leaders kick off rare disease hub to increase cross-center collaboration </a> </td></td> </tr><tr><td width="20" align="right" valign="top" style="padding:10px 0; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 14px/23px Roboto, Arial, Helvetica, sans-serif;"> <span >2</span>. <td width="5" style="font-size:1px; line-height:1px;"></td><td style="padding:10px 0; color:#2281D5; border-bottom:1px solid #E0E0E0; mso-ascii-font-family:Georgia, serif; font:16px/22px Merriweather, Georgia, serif;"> <a target="_blank" style="color:#2281D5; text-decoration:none;" href="https://endpts.com/aa/YNVRG2J6YV3BHGO4/" title="FDA places hold on Novavax's Covid-flu and standalone influenza vaccines" data-at="r" data-aid="M+R2ek7u"> FDA places hold on Novavax's Covid-flu and standalone influenza vaccines </a> </td></td> </tr><tr><td width="20" align="right" valign="top" style="padding:10px 0; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 14px/23px Roboto, Arial, Helvetica, sans-serif;"> <span >3</span>. <td width="5" style="font-size:1px; line-height:1px;"></td><td style="padding:10px 0; color:#2281D5; border-bottom:1px solid #E0E0E0; mso-ascii-font-family:Georgia, serif; font:16px/22px Merriweather, Georgia, serif;"> <a target="_blank" style="color:#2281D5; text-decoration:none;" href="https://endpts.com/aa/XXNU5TE0K0TZ9TDX/" title="FDA to reconsider removal of Lilly's GLP-1 drug from shortage list, a win for compounding pharmacies" data-at="r" data-aid="M+R2fkfl"> FDA to reconsider removal of Lilly's GLP-1 drug from shortage list, a win for compounding pharmacies </a> </td></td> </tr><tr><td width="20" align="right" valign="top" style="padding:10px 0; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 14px/23px Roboto, Arial, Helvetica, sans-serif;"> <span >4</span>. <td width="5" style="font-size:1px; line-height:1px;"></td><td style="padding:10px 0; color:#2281D5; border-bottom:1px solid #E0E0E0; mso-ascii-font-family:Georgia, serif; font:16px/22px Merriweather, Georgia, serif;"> <a target="_blank" style="color:#2281D5; text-decoration:none;" href="https://endpts.com/aa/QYUGWJOLLHFUZT71/" title="Exclusive: PhRMA attacks federal government's response to rebate model for 340B" data-at="r" data-aid="M+R1dkXl"> Exclusive: PhRMA attacks federal government's response to rebate model for 340B </a> </td></td> </tr><tr><td width="20" align="right" valign="top" style="padding:10px 0; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 14px/23px Roboto, Arial, Helvetica, sans-serif;"> <span >5</span>. <td width="5" style="font-size:1px; line-height:1px;"></td><td style="padding:10px 0; color:#2281D5; border-bottom:1px solid #E0E0E0; mso-ascii-font-family:Georgia, serif; font:16px/22px Merriweather, Georgia, serif;"> <a target="_blank" style="color:#2281D5; text-decoration:none;" href="https://endpts.com/aa/GJSLCWWU213Q2PKP/" title="Novartis used a PRV to speed Kisqali's latest indication, FDA says" data-at="r" data-aid="M+R2fUDm"> Novartis used a PRV to speed Kisqali's latest indication, FDA says </a> </td></td> </tr><tr><td width="20" align="right" valign="top" style="padding:10px 0; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 14px/23px Roboto, Arial, Helvetica, sans-serif;"> <span >6</span>. <td width="5" style="font-size:1px; line-height:1px;"></td><td style="padding:10px 0; color:#2281D5; border-bottom:1px solid #E0E0E0; mso-ascii-font-family:Georgia, serif; font:16px/22px Merriweather, Georgia, serif;"> <a target="_blank" style="color:#2281D5; text-decoration:none;" href="https://endpts.com/aa/NGQTW8B1RAJ90UTG/" title="FDA adcomm supports first potential drug for ultra-rare, fatal Barth syndrome" data-at="r" data-aid="M+R1d0Dk"> FDA adcomm supports first potential drug for ultra-rare, fatal Barth syndrome </a> </td></td> </tr><tr><td width="20" align="right" valign="top" style="padding:10px 0; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 14px/23px Roboto, Arial, Helvetica, sans-serif;"> <span >7</span>. <td width="5" style="font-size:1px; line-height:1px;"></td><td style="padding:10px 0; color:#2281D5; border-bottom:1px solid #E0E0E0; mso-ascii-font-family:Georgia, serif; font:16px/22px Merriweather, Georgia, serif;"> <a target="_blank" style="color:#2281D5; text-decoration:none;" href="https://endpts.com/aa/HZTD9LWKK303426F/" title="Stealth BioTherapeutics CEO discusses surprise adcomm support for ultra-rare disease drug" data-at="r" data-aid="M+R1dk7m"> Stealth BioTherapeutics CEO discusses surprise adcomm support for ultra-rare disease drug </a> </td></td> </tr><tr><td width="20" align="right" valign="top" style="padding:10px 0; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 14px/23px Roboto, Arial, Helvetica, sans-serif;"> <span >8</span>. <td width="5" style="font-size:1px; line-height:1px;"></td><td style="padding:10px 0; color:#2281D5; border-bottom:1px solid #E0E0E0; mso-ascii-font-family:Georgia, serif; font:16px/22px Merriweather, Georgia, serif;"> <a target="_blank" style="color:#2281D5; text-decoration:none;" href="https://endpts.com/aa/I3JGPOBZNURMCHBT/" title="Sen. Warren urges FTC to ‘carefully scrutinize’ Novo-Catalent deal over competition concerns" data-at="r" data-aid="M+R1d0bv"> Sen. Warren urges FTC to ‘carefully scrutinize’ Novo-Catalent deal over competition concerns </a> </td></td> </tr><tr><td width="20" align="right" valign="top" style="padding:10px 0; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 14px/23px Roboto, Arial, Helvetica, sans-serif;"> <span >9</span>. <td width="5" style="font-size:1px; line-height:1px;"></td><td style="padding:10px 0; color:#2281D5; mso-ascii-font-family:Georgia, serif; font:16px/22px Merriweather, Georgia, serif;"> <a target="_blank" style="color:#2281D5; text-decoration:none;" href="https://endpts.com/aa/5852J40C6SM4L969/" title="CMS looks to $2 out-of-pocket cap for some commonly used generic drugs" data-at="r" data-aid="M+R1eUfh"> CMS looks to $2 out-of-pocket cap for some commonly used generic drugs </a> </td></td> </tr> </table> </td> </tr> </table> </td> </tr> </table> </td></tr><tr> <td style="padding:20px 0 40px;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td style="background:#fff; padding:0 5px; border-top:1px solid #e0e0e0; border-bottom:1px solid #e0e0e0;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td class="plr-15" style="padding:25px;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="overflow:hidden;"> <img src="https://reports.endpts.com/assets/sendoff/so_zachary.jpg" width="128" style="width:128px; vertical-align:bottom; display:block;" alt="Zachary Brennan" /> </td> </tr> </table> </td> </tr> <tr> <td style="padding:25px 0;"> <table width="400" align="center" style="max-width:400px; width:100%!important; margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td height="2" style="background:#E0E0E0; font-size:1px; line-height:1px; color:#E0E0E0;">.</td> </tr> </table> </td> </tr> <tr> <td align="center" style="color:#616161; mso-ascii-font-family:Georgia, serif; font:italic 15px/25px Merriweather, Georgia, serif;"> <p><span>FDA Commissioner Rob Califf </span><a href="https://jamanetwork.com/journals/jama/fullarticle/2825146" target="_blank" rel="noopener">co-authored a JAMA</a><span> perspective yesterday on the regulation of AI, and the need for what the FDA calls "recurrent local postmarket performance monitoring." While the FDA has authorized thousands of AI-enabled devices and drugs discovered with the help of AI, the FDA authors caution that AI could create "significant harm if untended models’ performance deteriorates or focuses on financial return without adequate attention to impact on clinical outcomes."</span></p> </td> </tr> <tr> <td style="padding:25px 0;"> <table width="400" align="center" style="max-width:400px; width:100%!important; margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td height="2" style="background:#E0E0E0; font-size:1px; line-height:1px; color:#E0E0E0;">.</td> </tr> </table> </td> </tr> <tr> <td align="center" style="padding:0 0 6px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 18px/20px Merriweather, Georgia, serif;"> Zachary Brennan </td> </tr> <tr> <td align="center" style="padding:0 0 10px; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:400 14px/22px Roboto, Arial, Helvetica, sans-serif;"> <span >Senior Editor, Endpoints News</span> <br/> <a target="_blank" style="color:#2281D5; text-decoration:none;" href="https://twitter.com/ZacharyBrennan" title="ZacharyBrennan"> @ZacharyBrennan </a> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table> </td></tr><tr><td style="padding:0 5px 20px;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0"><tbody><tr><td class="wi-100p" align="center"> <img src="https://reports.endpts.com/cae9167a/e98d4b9d/assets/6fd1846f0f4e31f180f557682d19691c.jpg" width="600" style="width:600px; vertical-align:bottom; display:block;" alt=""></td> </tr><tr><td class="plr-15" style="background:#ffffff; padding:25px; border:1px solid #e0e0e0;"> <table class="imageCaptionTable" width="100%" ellpadding="0" cellspacing="0" style="margin: -12px 0 20px;"><tbody><tr><td style="padding: 0 0 8px; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:400 11px/14px Roboto, Arial, Helvetica, sans-serif; letter-spacing: 0.25px; border-bottom: 1px solid #e0e0e0;"> Peter Marks, CBER director (Jim Lo Scalzo/Pool via AP Images) </td> </tr></tbody></table><table width="100%" cellpadding="0" cellspacing="0"><tr><td style="padding:0 0 20px;"> <table align="left" style="margin:0 8px 0 0;" cellpadding="0" cellspacing="0"><tr><td width="28" height="28" style="background:#eeeeee; border-radius:4px;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td align="center" style="padding:4px; color:#666666; text-transform:uppercase; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 12px/14px Roboto, Arial, Helvetica, sans-serif;"> 1 </td> </tr></table></td> </tr></table><div> <a target="_blank" href="https://endpts.com/aa/IAAS12N2UFCLJHQ7/" style="color:#333333; mso-ascii-font-family:Georgia, serif; font:700 22px/29px Merriweather, Georgia, serif;" title="FDA lead&shy;ers kick off rare dis&shy;ease hub to in&shy;crease cross-cen&shy;ter col&shy;lab&shy;o&shy;ra&shy;tion" data-at="r" data-aid="M+R2eUbg">FDA leaders kick off rare disease hub to increase cross-center collaboration</a> </div> </td> </tr><tr><td style="padding:5px 0 20px; color:#616161; mso-ascii-font-family:Georgia, serif; font:14px/17px Merriweather, Georgia, serif;"> by <b >Zachary Brennan</b> </td> </tr><tr><td style="color:#616161; mso-ascii-font-family:Georgia, serif; font:16px/24px Merriweather, Georgia, serif;"><p style="margin:0 0 20px;">FDA officials, including the directors of CBER and CDER, on Wednesday launched a rare disease innovation hub at a <a href="https://www.fda.gov/drugs/news-events-human-drugs/advancing-rare-disease-therapies-through-fda-rare-disease-innovation-hub-10162024#event-information" target="_blank" rel="noopener nofollow" style="color:#2281D5;text-decoration:none;">public meeting</a>, with an aim to better collaborate and communicate across the two centers.</p><p style="margin:0 0 20px;">The hub will work across different rare diseases, the vast majority of which do not have any treatment. The FDA <a href="https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/fda-rare-disease-innovation-hub" target="_blank" rel="noopener nofollow" style="color:#2281D5;text-decoration:none;">said</a> it will "particularly focus on products intended for smaller populations" or for diseases in which the natural history is not well understood.</p><p style="margin:0 0 20px;">The FDA's leaders stressed that the hub still needs an official leader — it's hiring a director of strategic engagement — to advance the collaboration while noting that Congress did not provide any additional funding for the hub's creation.</p></td></tr><tr><td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"><tr><td class="active-t h-n" align="center" style="background:#2281D5; mso-padding-alt:14px 25px; text-transform:uppercase; border-radius:3px; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> <a target="_blank" style="color:#fff; text-decoration:none; display:block; padding:14px 25px;" href="https://endpts.com/aa/IAAS12N2UFCLJHQ7/" data-at="r" data-aid="M+R2eUbg">Click here to continue reading</a> </td> </tr></table></td> </tr></table></td> </tr></tbody></table></td> </tr><tr><td style="padding:0 5px 20px;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0"><tbody><tr><td class="plr-15" style="background:#ffffff; padding:25px; border:1px solid #e0e0e0;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td style="padding:0 0 20px;"> <table align="left" style="margin:0 8px 0 0;" cellpadding="0" cellspacing="0"><tr><td width="28" height="28" style="background:#eeeeee; border-radius:4px;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td align="center" style="padding:4px; color:#666666; text-transform:uppercase; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 12px/14px Roboto, Arial, Helvetica, sans-serif;"> 2 </td> </tr></table></td> </tr></table><div> <a target="_blank" href="https://endpts.com/aa/YNVRG2J6YV3BHGO4/" style="color:#333333; mso-ascii-font-family:Georgia, serif; font:700 22px/29px Merriweather, Georgia, serif;" title="FDA places hold on No&shy;vavax's Covid-flu and stand&shy;alone in&shy;fluen&shy;za vac&shy;cines" data-at="r" data-aid="M+R2ek7u">FDA places hold on Novavax's Covid-flu and standalone influenza vaccines</a> </div> </td> </tr><tr><td style="padding:5px 0 20px; color:#616161; mso-ascii-font-family:Georgia, serif; font:14px/17px Merriweather, Georgia, serif;"> by <b >Max Gelman</b> </td> </tr><tr><td style="color:#616161; mso-ascii-font-family:Georgia, serif; font:16px/24px Merriweather, Georgia, serif;"><p style="margin:0 0 20px;">Novavax’s post-Covid path ran into a speed bump Wednesday, as the company <a href="https://www.prnewswire.com/news-releases/update-on-novavaxs-covid-19-influenza-combination-and-stand-alone-influenza-phase-3-trial-302277807.html" target="_blank" rel="noopener nofollow" style="color:#2281D5;text-decoration:none;">announced</a> a clinical hold on its Covid-influenza combination vaccine and its standalone flu shot.</p><p style="margin:0 0 20px;">The FDA placed the hold after an individual outside the US reported a side effect of “motor neuropathy,” according to a press release. The individual was participating in Novavax’s Phase 2 trial for the combination shot, which wrapped up in July 2023, and reported the side effect last month.</p><p style="margin:0 0 20px;">“While we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA,” Novavax CMO Robert Walker said in a statement.</p><p style="margin:0 0 20px;">Novavax’s stock price NVAX fell by as much as 20% on Wednesday morning.</p></td></tr><tr><td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"><tr><td class="active-t h-n" align="center" style="background:#2281D5; mso-padding-alt:14px 25px; text-transform:uppercase; border-radius:3px; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> <a target="_blank" style="color:#fff; text-decoration:none; display:block; padding:14px 25px;" href="https://endpts.com/aa/YNVRG2J6YV3BHGO4/" data-at="r" data-aid="M+R2ek7u">Click here to continue reading</a> </td> </tr></table></td> </tr></table></td> </tr></tbody></table></td> </tr><tr><td style="padding:0 5px 20px;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0"><tbody><tr><td class="plr-15" style="background:#ffffff; padding:25px; border:1px solid #e0e0e0;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td style="padding:0 0 20px;"> <table align="left" style="margin:0 8px 0 0;" cellpadding="0" cellspacing="0"><tr><td width="28" height="28" style="background:#eeeeee; border-radius:4px;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td align="center" style="padding:4px; color:#666666; text-transform:uppercase; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 12px/14px Roboto, Arial, Helvetica, sans-serif;"> 3 </td> </tr></table></td> </tr></table><div> <a target="_blank" href="https://endpts.com/aa/XXNU5TE0K0TZ9TDX/" style="color:#333333; mso-ascii-font-family:Georgia, serif; font:700 22px/29px Merriweather, Georgia, serif;" title="FDA to re&shy;con&shy;sid&shy;er re&shy;moval of Lil&shy;ly's GLP-1 drug from short&shy;age list, a win for com&shy;pound&shy;ing phar&shy;ma&shy;cies" data-at="r" data-aid="M+R2fkfl">FDA to reconsider removal of Lilly's GLP-1 drug from shortage list, a win for compounding pharmacies</a> </div> </td> </tr><tr><td style="padding:5px 0 20px; color:#616161; mso-ascii-font-family:Georgia, serif; font:14px/17px Merriweather, Georgia, serif;"> by <b >Shelby Livingston</b> </td> </tr><tr><td style="color:#616161; mso-ascii-font-family:Georgia, serif; font:16px/24px Merriweather, Georgia, serif;"><p style="margin:0 0 20px;">The FDA said it will reconsider the removal of Eli Lilly’s GLP-1 drug tirzepatide from its official shortage list, after a trade group representing large compounding pharmacies <a href="https://endpts.com/aa/K2NCKQ9AFR25D7US/" target="_blank" rel="noopener" style="color:#2281D5;text-decoration:none;" data-at="r" data-aid="M+R1fEHl">challenged the move</a>.</p><p style="margin:0 0 20px;">A federal court in Texas on Friday granted the FDA’s unopposed motion to stay litigation over the drug's removal from shortage. The agency's declaration that the shortage was over ended certain pharmacies’ ability to mix their own versions of Lilly’s popular obesity drug.</p><p style="margin:0 0 20px;">The legal development will send the matter back to the FDA for reevaluation, according to a court filing, and could reopen the door to some compounding pharmacies dispensing their versions of the drug. The FDA also said it would not take enforcement action against certain pharmacies for compounding tirzepatide during that time.</p></td></tr><tr><td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"><tr><td class="active-t h-n" align="center" style="background:#2281D5; mso-padding-alt:14px 25px; text-transform:uppercase; border-radius:3px; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> <a target="_blank" style="color:#fff; text-decoration:none; display:block; padding:14px 25px;" href="https://endpts.com/aa/XXNU5TE0K0TZ9TDX/" data-at="r" data-aid="M+R2fkfl">Click here to continue reading</a> </td> </tr></table></td> </tr></table></td> </tr></tbody></table></td> </tr><tr><td style="padding:0 5px 20px;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0"><tbody><tr><td class="plr-15" style="background:#ffffff; padding:25px; border:1px solid #e0e0e0;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td style="padding:0 0 20px;"> <table align="left" style="margin:0 8px 0 0;" cellpadding="0" cellspacing="0"><tr><td width="28" height="28" style="background:#eeeeee; border-radius:4px;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td align="center" style="padding:4px; color:#666666; text-transform:uppercase; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 12px/14px Roboto, Arial, Helvetica, sans-serif;"> 4 </td> </tr></table></td> </tr></table><div> <a target="_blank" href="https://endpts.com/aa/QYUGWJOLLHFUZT71/" style="color:#333333; mso-ascii-font-family:Georgia, serif; font:700 22px/29px Merriweather, Georgia, serif;" title="Ex&shy;clu&shy;sive: PhRMA at&shy;tacks fed&shy;er&shy;al gov&shy;ern&shy;men&shy;t's re&shy;sponse to re&shy;bate mod&shy;el for 340B" data-at="r" data-aid="M+R1dkXl">Exclusive: PhRMA attacks federal government's response to rebate model for 340B</a> </div> </td> </tr><tr><td style="padding:5px 0 20px; color:#616161; mso-ascii-font-family:Georgia, serif; font:14px/17px Merriweather, Georgia, serif;"> by <b >Nicole DeFeudis</b> </td> </tr><tr><td style="color:#616161; mso-ascii-font-family:Georgia, serif; font:16px/24px Merriweather, Georgia, serif;"><p style="margin:0 0 20px;">The pharma industry’s DC-based lobbying group urged the federal government on Friday to get on board with alternative models for 340B drug price discounts.</p><p style="margin:0 0 20px;">In a letter to the Health Resources and Services Administration, PhRMA said the federal drug discount program is “out of step with the realities of the current health care system.” 340B was created to help hospitals serving low-income populations, and has <a href="https://endpts.com/aa/1P6Y6HQQD5JUA5B2/" target="_blank" rel="noopener" style="color:#2281D5;text-decoration:none;" data-at="r" data-aid="M+pzfEfu">grown significantly</a> in recent years. But PhRMA argued Friday that HRSA’s oversight “simply has not kept pace” with that growth.</p><p style="margin:0 0 20px;">The trade group made the case for alternative distribution models to ensure drugmakers aren't giving out duplicate discounts, citing a rebate model recently proposed by Johnson & Johnson. The drugmaker <a href="https://endpts.com/aa/9W3W9JL4UTOQ1KIW/" target="_blank" rel="noopener" style="color:#2281D5;text-decoration:none;" data-at="r" data-aid="M+t4eUbv">announced</a> in August that some hospitals would no longer receive 340B discounts upfront on Xarelto and Stelara. Under the plan, the hospitals would recoup the discounts via rebates after validating certain data.</p></td></tr><tr><td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"><tr><td class="active-t h-n" align="center" style="background:#2281D5; mso-padding-alt:14px 25px; text-transform:uppercase; border-radius:3px; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> <a target="_blank" style="color:#fff; text-decoration:none; display:block; padding:14px 25px;" href="https://endpts.com/aa/QYUGWJOLLHFUZT71/" data-at="r" data-aid="M+R1dkXl">Click here to continue reading</a> </td> </tr></table></td> </tr></table></td> </tr></tbody></table></td> </tr><tr><td style="padding:0 5px 20px;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0"><tbody><tr><td class="plr-15" style="background:#ffffff; padding:25px; border:1px solid #e0e0e0;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td style="padding:0 0 20px;"> <table align="left" style="margin:0 8px 0 0;" cellpadding="0" cellspacing="0"><tr><td width="28" height="28" style="background:#eeeeee; border-radius:4px;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td align="center" style="padding:4px; color:#666666; text-transform:uppercase; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 12px/14px Roboto, Arial, Helvetica, sans-serif;"> 5 </td> </tr></table></td> </tr></table><div> <a target="_blank" href="https://endpts.com/aa/GJSLCWWU213Q2PKP/" style="color:#333333; mso-ascii-font-family:Georgia, serif; font:700 22px/29px Merriweather, Georgia, serif;" title="No&shy;var&shy;tis used a PRV to speed Kisqal&shy;i's lat&shy;est in&shy;di&shy;ca&shy;tion, FDA says" data-at="r" data-aid="M+R2fUDm">Novartis used a PRV to speed Kisqali's latest indication, FDA says</a> </div> </td> </tr><tr><td style="padding:5px 0 20px; color:#616161; mso-ascii-font-family:Georgia, serif; font:14px/17px Merriweather, Georgia, serif;"> by <b >Zachary Brennan</b> </td> </tr><tr><td style="color:#616161; mso-ascii-font-family:Georgia, serif; font:16px/24px Merriweather, Georgia, serif;"><p style="margin:0 0 20px;">Novartis used one of its priority review vouchers (PRV) to speed the September approval of Kisqali in early breast cancer, the FDA said Monday.</p><p style="margin:0 0 20px;">The FDA <a href="https://public-inspection.federalregister.gov/2024-23651.pdf" target="_blank" rel="noopener nofollow" style="color:#2281D5;text-decoration:none;">did not disclose</a> where this PRV came to Novartis from, but the Swiss biotech has publicly disclosed an industry-leading <a href="https://endpts.com/aa/SP58IOSBV2KDCFZO/" target="_blank" rel="noopener" style="color:#2281D5;text-decoration:none;" data-at="r" data-aid="NOx5e0Pl">seven PRVs</a>, three of which were acquired on the open market for between $21 million and $130 million each.</p><p style="margin:0 0 20px;">The use of a PRV sped up the supplemental approval by about four months. Novartis noted that this latest nod for Kisqali <a href="https://endpts.com/aa/8ICETD6KMPN61VA3/" target="_blank" rel="noopener" style="color:#2281D5;text-decoration:none;" data-at="r" data-aid="M+Ryf07v">roughly doubles</a> the treatable adjuvant population and includes patients whose cancer has not yet spread to their lymph nodes. Novartis did not immediately respond to a request for comment.</p></td></tr><tr><td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"><tr><td class="active-t h-n" align="center" style="background:#2281D5; mso-padding-alt:14px 25px; text-transform:uppercase; border-radius:3px; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> <a target="_blank" style="color:#fff; text-decoration:none; display:block; padding:14px 25px;" href="https://endpts.com/aa/GJSLCWWU213Q2PKP/" data-at="r" data-aid="M+R2fUDm">Click here to continue reading</a> </td> </tr></table></td> </tr></table></td> </tr></tbody></table></td> </tr><tr><td style="padding:0 5px 20px;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0"><tbody><tr><td class="plr-15" style="background:#ffffff; padding:25px; border:1px solid #e0e0e0;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td style="padding:0 0 20px;"> <table align="left" style="margin:0 8px 0 0;" cellpadding="0" cellspacing="0"><tr><td width="28" height="28" style="background:#eeeeee; border-radius:4px;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td align="center" style="padding:4px; color:#666666; text-transform:uppercase; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 12px/14px Roboto, Arial, Helvetica, sans-serif;"> 6 </td> </tr></table></td> </tr></table><div> <a target="_blank" href="https://endpts.com/aa/NGQTW8B1RAJ90UTG/" style="color:#333333; mso-ascii-font-family:Georgia, serif; font:700 22px/29px Merriweather, Georgia, serif;" title="FDA ad&shy;comm sup&shy;ports first po&shy;ten&shy;tial drug for ul&shy;tra-rare, fa&shy;tal Barth syn&shy;drome" data-at="r" data-aid="M+R1d0Dk">FDA adcomm supports first potential drug for ultra-rare, fatal Barth syndrome</a> </div> </td> </tr><tr><td style="padding:5px 0 20px; color:#616161; mso-ascii-font-family:Georgia, serif; font:14px/17px Merriweather, Georgia, serif;"> by <b >Zachary Brennan</b> </td> </tr><tr><td style="color:#616161; mso-ascii-font-family:Georgia, serif; font:16px/24px Merriweather, Georgia, serif;"><p style="margin:0 0 20px;">Heartbreaking anecdotes from the patients, parents and doctors of children with the ultra-rare and fatal Barth syndrome won over an FDA advisory committee on Thursday, likely setting up a tough decision for regulators in the coming months.</p><p style="margin:0 0 20px;">The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-6 that Stealth BioTherapeutics' drug elamipretide was effective at treating the disease.</p><p style="margin:0 0 20px;">The surprising vote followed questions raised by the committee about drawing conclusions from the use of a natural history data-based trial, as well as the variability of the effects seen in a small placebo-controlled trial. While some committee members saw data from a walk test as a positive signal from the drug's pivotal trial, others questioned the reliability of the data.</p></td></tr><tr><td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"><tr><td class="active-t h-n" align="center" style="background:#2281D5; mso-padding-alt:14px 25px; text-transform:uppercase; border-radius:3px; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> <a target="_blank" style="color:#fff; text-decoration:none; display:block; padding:14px 25px;" href="https://endpts.com/aa/NGQTW8B1RAJ90UTG/" data-at="r" data-aid="M+R1d0Dk">Click here to continue reading</a> </td> </tr></table></td> </tr></table></td> </tr></tbody></table></td> </tr><tr><td style="padding:0 5px 20px;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0"><tbody><tr><td class="wi-100p" align="center"> <img src="https://reports.endpts.com/cae9167a/e98d4b9d/assets/a2a7356d6c4dc38357e5dc1601a9d761.jpg" width="600" style="width:600px; vertical-align:bottom; display:block;" alt=""></td> </tr><tr><td class="plr-15" style="background:#ffffff; padding:25px; border:1px solid #e0e0e0;"> <table class="imageCaptionTable" width="100%" ellpadding="0" cellspacing="0" style="margin: -12px 0 20px;"><tbody><tr><td style="padding: 0 0 8px; color:#616161; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:400 11px/14px Roboto, Arial, Helvetica, sans-serif; letter-spacing: 0.25px; border-bottom: 1px solid #e0e0e0;"> Reenie McCarthy, Stealth BioTherapeutics CEO </td> </tr></tbody></table><table width="100%" cellpadding="0" cellspacing="0"><tr><td style="padding:0 0 20px;"> <table align="left" style="margin:0 8px 0 0;" cellpadding="0" cellspacing="0"><tr><td width="28" height="28" style="background:#eeeeee; border-radius:4px;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td align="center" style="padding:4px; color:#666666; text-transform:uppercase; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 12px/14px Roboto, Arial, Helvetica, sans-serif;"> 7 </td> </tr></table></td> </tr></table><div> <a target="_blank" href="https://endpts.com/aa/HZTD9LWKK303426F/" style="color:#333333; mso-ascii-font-family:Georgia, serif; font:700 22px/29px Merriweather, Georgia, serif;" title="Stealth Bio&shy;Ther&shy;a&shy;peu&shy;tics CEO dis&shy;cuss&shy;es sur&shy;prise ad&shy;comm sup&shy;port for ul&shy;tra-rare dis&shy;ease drug" data-at="r" data-aid="M+R1dk7m">Stealth BioTherapeutics CEO discusses surprise adcomm support for ultra-rare disease drug</a> </div> </td> </tr><tr><td style="padding:5px 0 20px; color:#616161; mso-ascii-font-family:Georgia, serif; font:14px/17px Merriweather, Georgia, serif;"> by <b >Zachary Brennan</b> </td> </tr><tr><td style="color:#616161; mso-ascii-font-family:Georgia, serif; font:16px/24px Merriweather, Georgia, serif;"><p style="margin:0 0 20px;">This week, Stealth BioTherapeutics CEO Reenie McCarthy faced a seemingly insurmountable roadblock with the company's drug for the ultra-rare, fatal mitochondrial disease Barth syndrome. FDA reviewers had extensively questioned the data supporting the drug's efficacy. And the agency had already turned down Stealth once.</p><p style="margin:0 0 20px;">Instead, the advisory committee on Thursday voted <a href="https://endpts.com/aa/NGQTW8B1RAJ90UTG/" target="_blank" rel="noopener" style="color:#2281D5;text-decoration:none;" data-at="r" data-aid="M+R1d0Dk">10-6 in support</a> of the drug, following testimony from patients and their families, as well as doctors who had treated patients with it.</p><p style="margin:0 0 20px;">The result was a substantial win for the small, 50-person private company and its CEO. McCarthy joined <em>Endpoints News</em> via Zoom on Friday to discuss the surprise vote.</p></td></tr><tr><td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"><tr><td class="active-t h-n" align="center" style="background:#2281D5; mso-padding-alt:14px 25px; text-transform:uppercase; border-radius:3px; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> <a target="_blank" style="color:#fff; text-decoration:none; display:block; padding:14px 25px;" href="https://endpts.com/aa/HZTD9LWKK303426F/" data-at="r" data-aid="M+R1dk7m">Click here to continue reading</a> </td> </tr></table></td> </tr></table></td> </tr></tbody></table></td> </tr><tr><td style="padding:0 5px 20px;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0"><tbody><tr><td class="plr-15" style="background:#ffffff; padding:25px; border:1px solid #e0e0e0;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td style="padding:0 0 20px;"> <table align="left" style="margin:0 8px 0 0;" cellpadding="0" cellspacing="0"><tr><td width="28" height="28" style="background:#eeeeee; border-radius:4px;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td align="center" style="padding:4px; color:#666666; text-transform:uppercase; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 12px/14px Roboto, Arial, Helvetica, sans-serif;"> 8 </td> </tr></table></td> </tr></table><div> <a target="_blank" href="https://endpts.com/aa/I3JGPOBZNURMCHBT/" style="color:#333333; mso-ascii-font-family:Georgia, serif; font:700 22px/29px Merriweather, Georgia, serif;" title="Sen. War&shy;ren urges FTC to ‘care&shy;ful&shy;ly scru&shy;ti&shy;nize’ No&shy;vo-Catal&shy;ent deal over com&shy;pe&shy;ti&shy;tion con&shy;cerns" data-at="r" data-aid="M+R1d0bv">Sen. Warren urges FTC to ‘carefully scrutinize’ Novo-Catalent deal over competition concerns</a> </div> </td> </tr><tr><td style="padding:5px 0 20px; color:#616161; mso-ascii-font-family:Georgia, serif; font:14px/17px Merriweather, Georgia, serif;"> by <b >Anna Brown</b> </td> </tr><tr><td style="color:#616161; mso-ascii-font-family:Georgia, serif; font:16px/24px Merriweather, Georgia, serif;"><p style="margin:0 0 20px;">Sen. Elizabeth Warren (D-MA) has put the spotlight on Novo Holdings’ acquisition of Catalent, expressing concerns that the deal could give Novo Nordisk "unprecedented visibility" into its competitors' manufacturing and allow it to potentially dominate the obesity and weight loss market unfairly.</p><p style="margin:0 0 20px;">In a <a href="https://www.warren.senate.gov/imo/media/doc/catalent1.pdf" target="_blank" rel="noopener nofollow" style="color:#2281D5;text-decoration:none;">letter</a> dated Wednesday, Warren asked the Federal Trade Commission to “block” the deal if it’s found to be illegal under antitrust laws. As part of the <a href="https://endpts.com/aa/IVZIKF83XVC3D774/" target="_blank" rel="noopener" style="color:#2281D5;text-decoration:none;" data-at="r" data-aid="M+h4e0Xn">$16.5 billion pact</a>, Novo Nordisk is set to pay $11 billion to Novo Holdings for three Catalent sites, one of which makes drugs for rival Eli Lilly. Catalent has at least 53 facilities, according to its annual <a href="https://d18rn0p25nwr6d.cloudfront.net/CIK-0001596783/bf127f37-143c-4b45-bfba-ccc7d14b8b0e.pdf" target="_blank" rel="noopener nofollow" style="color:#2281D5;text-decoration:none;">report</a> released last month.</p></td></tr><tr><td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"><tr><td class="active-t h-n" align="center" style="background:#2281D5; mso-padding-alt:14px 25px; text-transform:uppercase; border-radius:3px; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> <a target="_blank" style="color:#fff; text-decoration:none; display:block; padding:14px 25px;" href="https://endpts.com/aa/I3JGPOBZNURMCHBT/" data-at="r" data-aid="M+R1d0bv">Click here to continue reading</a> </td> </tr></table></td> </tr></table></td> </tr></tbody></table></td> </tr><tr><td style="padding:0 5px 20px;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0"><tbody><tr><td class="plr-15" style="background:#ffffff; padding:25px; border:1px solid #e0e0e0;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td style="padding:0 0 20px;"> <table align="left" style="margin:0 8px 0 0;" cellpadding="0" cellspacing="0"><tr><td width="28" height="28" style="background:#eeeeee; border-radius:4px;"> <table width="100%" cellpadding="0" cellspacing="0"><tr><td align="center" style="padding:4px; color:#666666; text-transform:uppercase; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:700 12px/14px Roboto, Arial, Helvetica, sans-serif;"> 9 </td> </tr></table></td> </tr></table><div> <a target="_blank" href="https://endpts.com/aa/5852J40C6SM4L969/" style="color:#333333; mso-ascii-font-family:Georgia, serif; font:700 22px/29px Merriweather, Georgia, serif;" title="CMS looks to $2 out-of-pock&shy;et cap for some com&shy;mon&shy;ly used gener&shy;ic drugs" data-at="r" data-aid="M+R1eUfh">CMS looks to $2 out-of-pocket cap for some commonly used generic drugs</a> </div> </td> </tr><tr><td style="padding:5px 0 20px; color:#616161; mso-ascii-font-family:Georgia, serif; font:14px/17px Merriweather, Georgia, serif;"> by <b >Nicole DeFeudis</b> </td> </tr><tr><td style="color:#616161; mso-ascii-font-family:Georgia, serif; font:16px/24px Merriweather, Georgia, serif;"><p style="margin:0 0 20px;">The Centers for Medicare and Medicaid Services on Wednesday published a list of 101 commonly used generic medicines that would cost some Medicare patients no greater than $2 per month under a proposed new model.</p><p style="margin:0 0 20px;">It’s a sign the Biden-Harris administration is doubling down on its promise to lower prescription drug costs, a <a href="https://endpts.com/aa/JFOZQUUB95WEAZEI/" target="_blank" rel="noopener" style="color:#2281D5;text-decoration:none;" data-at="r" data-aid="M+l3fETi">key talking point</a> just a month ahead of the 2024 presidential election. The model would build on recent efforts, including the Inflation Reduction Act, which capped monthly out-of-pocket costs for seniors at $2,000 and allowed Medicare to <a href="https://endpts.com/aa/FXE19XDJY2QY7RA6/" target="_blank" rel="noopener" style="color:#2281D5;text-decoration:none;" data-at="r" data-aid="M+R0eUfg">negotiate</a> certain prescription drug prices for the first time.</p><p style="margin:0 0 20px;">“CMS is using every lever at its disposal to ensure people with Medicare have access to lower-cost prescriptions,” CMS Administrator Chiquita Brooks-LaSure said in a news release.</p></td></tr><tr><td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"><tr><td class="active-t h-n" align="center" style="background:#2281D5; mso-padding-alt:14px 25px; text-transform:uppercase; border-radius:3px; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> <a target="_blank" style="color:#fff; text-decoration:none; display:block; padding:14px 25px;" href="https://endpts.com/aa/5852J40C6SM4L969/" data-at="r" data-aid="M+R1eUfh">Click here to continue reading</a> </td> </tr></table></td> </tr></table></td> </tr></tbody></table></td> </tr><tr><td style="padding: 0 5px 40px;"> <table class="w-100p" width="600" align="center" style="max-width:600px; margin:0 auto;" cellpadding="0" cellspacing="0">  <tr> <td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <th class="tflex" align="left" style="vertical-align:top;"> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> John Carroll </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Editor & Founder </td> </tr> </table> </td> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Arsalan Arif </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Publisher & Founder </td> </tr> </table> </td> </tr> </table> </th> </tr> </table> </td> </tr>  <tr> <td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <th class="tflex" align="left" style="vertical-align:top;"> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Igor Yavych </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Chief Technical Officer </td> </tr> </table> </td> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Valentin Manov </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Creative Director </td> </tr> </table> </td> </tr> </table> </th> <th class="tflex" align="left" style="vertical-align:top;"> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Ryan McRae </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Chief Revenue Officer </td> </tr> </table> </td> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Amanda Florez </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Chief of Staff </td> </tr> </table> </td> </tr> </table> </th> </tr> </table> </td> </tr> <tr> <td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <th class="tflex" align="left" style="vertical-align:top;"> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Drew Armstrong </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Executive Editor </td> </tr> </table> </td> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Jaimy Lee </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Deputy Editor </td> </tr> </table> </td> </tr> </table> </th> <th class="tflex" align="left" style="vertical-align:top;"> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Lydia R. Pflanzer </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Deputy Editor </td> </tr> </table> </td> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Zachary Brennan </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Senior Editor </td> </tr> </table> </td> </tr> </table> </th> </tr> </table> </td> </tr> <tr> <td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <th class="tflex" align="left" style="vertical-align:top;"> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Max Gelman </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Senior Editor </td> </tr> </table> </td> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Julie O'Meara </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Executive Director, Brand Partnerships </td> </tr> </table> </td> </tr> </table> </th> <th class="tflex" align="left" style="vertical-align:top;"> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> Melissa Nazzaro </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Executive Director, Brand Partnerships </td> </tr> </table> </td> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="padding:0 7px 3px; color:#333; mso-ascii-font-family:Georgia, serif; font:700 15px/21px Merriweather, Georgia, serif;"> James Cherrick </td> </tr> <tr> <td align="center" style="padding:0 7px; color:#999; mso-ascii-font-family:Arial, Helvetica, sans-serif; font:13px/17px Roboto, Arial, Helvetica, sans-serif;"> Controller </td> </tr> </table> </td> </tr> </table> </th> </tr> </table> </td> </tr> <tr> <td> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <th class="tflex" align="left" style="vertical-align:top;"> <table align="center" style="margin:0 auto;" cellpadding="0" cellspacing="0"> <tr> <td width="150" style="padding:20px 0 0;"> <table width="100%" cellpadding="0" cellspacing="0"> <tr> <td align="center" style="mso-ascii-font-family:Arial, Helvetica, sans-serif; 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