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GSK Shingles Vaccine's Next Stop Is CDC Panel After US FDA Approval

 
• By Brenda Sandburg

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.

Shingrix Zoster Vaccine

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 addition to 90% plus efficacy in preventing shingles, Shingrix

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More from Approvals

Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By Vibha Sharma

The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

More from Product Reviews

Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By Vibha Sharma

The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.