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      <title>Module 4: Discussion Group A by Supriya Munshaw</title>
      <link>https://padlet.com/smunshaw/zesi1rppksj2</link>
      <description>Find a recent news story (last 6 months to 1 year) showcasing either a) a regulatory move made by the FDA. Comment on whether their decision would be beneficial or detrimental to the pharmaceutical industry OR b) a regulatory strategy used by a pharmaceutical company for one of their drugs. In this case, comment on why the company may have used this strategy.</description>
      <language>en-us</language>
      <pubDate>2018-03-04 18:09:04 UTC</pubDate>
      <lastBuildDate>2018-03-27 18:03:53 UTC</lastBuildDate>
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         <title>Sarepta Announces Plans to File New Drug Application for Golodirsen - entry by Danny Goldberg</title>
         <author></author>
         <link>https://padlet.com/smunshaw/zesi1rppksj2/wish/246630229</link>
         <description><![CDATA[<div>On March 12, Sarepta Therapeutics <a href="http://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-plan-submit-new-drug-application">announced</a> their intent to submit a new drug application (NDA) for accelerated approval of their drug golodirsen to the FDA. If approved, this would be their second commercialized product. Looking across Sarepta's pipeline, they are focused on treating children with Duchenne Muscular Dystrophy (DMD) amenable to exon skipping of the DMD gene. DMD is a disease characterized by muscle degeneration and weakness; there are 9 types of muscular dystrophy. The exon skipping works to restore dystrophin, which is the protein DMD patients lack that keeps muscles together.&nbsp;<br><br></div><div>In assessing this development, Sarepta's decision to file an NDA for their next DMD drug in the pipeline suggests an accelerated growth strategy, as golodirsen wasn't expected to be commercialized until <a href="https://www.firstwordpharma.com/footer/benefits?tsid=17">2020</a>. Sarepta is likely pursuing this strategy for 2 reasons: 1) to take a clear lead in the DMD space in terms of market share for therapies, and 2) to execute on a their <a href="https://www.marketwatch.com/story/sarepta-is-making-a-bold-bet-on-genetic-medicine-2018-01-10">vision</a> to be "one of the most important genetic medicine companies in the next five years," according to CEO Douglas Ingram.&nbsp;<br><br></div><div>There is a need to go at a feverish pace if Sarepta wants to achieve this vision. According to the WSJ, competitors Novartis and Spark Therapeutics have taken a lead in the precision genetic medicine field. Following the JP Morgan conference, the largest annual health care conference, the discussion and exploration of gene therapy has gained significant public traction. Sarepta likely felt increasing pressure from shareholders after this conference at the beginning of the year to make a bold splash in a competitive gene therapy market. Getting this product commercialized quickly sets the company up for financial success over time and makes a statement that Sarepta is a name to compete with in genetic medicine development.</div>]]></description>
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         <pubDate>2018-03-27 18:02:04 UTC</pubDate>
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