Shingrix's 90%-plus efficacy and reduction in postherpetic neuralgia gives GSK's vaccine edge over Merck's Zostavax. CDC advisory committee to vote on lower age for vaccination and use in Zostavax recipients.
GlaxoSmithKline PLC leveraged a US FDA advisory committee to help get a strong label for its shingles vaccine Shingrix. Now the company hopes a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) will all but guarantee strong sales for the product.
FDA approved Shringrix on Oct. 20 for prevention of herpes zoster (shingles) in adults aged 50 years and older. In...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
<p>Executive Summary</p> <p>Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.</p>
<p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
