<code id='2AEE17CD61'></code><style id='2AEE17CD61'></style>
    • <acronym id='2AEE17CD61'></acronym>
      <center id='2AEE17CD61'><center id='2AEE17CD61'><tfoot id='2AEE17CD61'></tfoot></center><abbr id='2AEE17CD61'><dir id='2AEE17CD61'><tfoot id='2AEE17CD61'></tfoot><noframes id='2AEE17CD61'>

    • <optgroup id='2AEE17CD61'><strike id='2AEE17CD61'><sup id='2AEE17CD61'></sup></strike><code id='2AEE17CD61'></code></optgroup>
        1. <b id='2AEE17CD61'><label id='2AEE17CD61'><select id='2AEE17CD61'><dt id='2AEE17CD61'><span id='2AEE17CD61'></span></dt></select></label></b><u id='2AEE17CD61'></u>
          <i id='2AEE17CD61'><strike id='2AEE17CD61'><tt id='2AEE17CD61'><pre id='2AEE17CD61'></pre></tt></strike></i>

          focus

          focus

          author:leisure time    Page View:75
          European Medicines Agency Suffers Cyber Attack in Amsterdam
          Paulo Amorim / VWPics via AP Images

          LONDON — This week, European regulators are considering an appeal from Amylyx Pharmaceuticals after initially recommending against approving the company’s ALS treatment — the latest potential turning point for a drug that has seen its share of ups and downs with regulatory bodies.

          In June, a European Medicines Agency committee issued a negative review of Amylyx’s drug, called Albrioza, and cast doubt on whether it had demonstrated effectiveness in its pivotal study. That would have almost certainly led to a rejection by regulators, but Amylyx requested what’s called a re-examination of the opinion. On Tuesday, the EMA held a meeting on the appeal, and a decision is expected in the coming weeks.

          advertisement

          “There are patients who are dying and they really want access to the drug,” said Evy Reviers, the chairwoman of the European Organization for Professionals and Patients with ALS, whose father has the neurological disease.

          Get unlimited access to award-winning journalism and exclusive events.

          Subscribe Log In

          focus

          As demand for Covid shots wanes, Moderna seeks its next success
          As demand for Covid shots wanes, Moderna seeks its next success

          RubyWallauforSTATModernachairmanNoubarAfeyanexudedstarpowerearlierthismonthashecommandedthespotlight

          read more
          Depression: FDA OKs Otsuka Pharmaceuticals digital therapeutic
          Depression: FDA OKs Otsuka Pharmaceuticals digital therapeutic

          AdobeTheFoodandDrugAdministrationhasclearedOtsukaPharmaceutical’sdigitaltreatmentformajordepressived

          read more
          Food as medicine: CMS rules hamper 'prescribing' of fruits, veggies
          Food as medicine: CMS rules hamper 'prescribing' of fruits, veggies

          AdobeSometimes,anappleadayreallyisjustwhatthedoctorordered.Andforthepastseveralyears,organizationsli

          read more

          Young boy dies in trial for Pfizer Duchenne gene therapy

          MarkLennihan/APAyoungboydiedinatrialforPfizer’sexperimentalgenetherapyforDuchennemusculardystrophy,t