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GSK Files Blockbuster Hopeful Shingrix With FDA

 
• By Jessica Merrill

The shingles vaccine is considered one of the products with the biggest commercial potential for GSK in the near-term.

GlaxoSmithKline PLC has filed the shingles vaccine Shingrix with FDA, positioning the company for a late 2017 launch of what is expected to be a significant revenue generator. The company announced the BLA filing for Shingrix for the prevention of herpes zoster (shingles) in people age 50 and older on Oct. 24 and said it is on track to file the vaccine in Canada and Europe also in 2016.

The regulatory filing is an important milestone for GSK because Shingrix is considered one of the products in GSK’s pipeline...

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J&J And Novartis On 2025’s Biggest M&A Deals And What Can Derail A Buyout

 
• By Andrew McConaghie

Three big pharma business development heads at the recent Jefferies conference discussed their activities in 2025, and offered some advice to potential partners on how to avoid deal talks breaking down.

Sanofi Flies The Flag For France

 
• By Kevin Grogan

The Paris-headquartered giant has put the spotlight on its extensive investments at home.

Some CAR-Ts Are Thriving While Others Are Falling Behind. Why?

 
• By Alaric DeArment

With Gilead reporting that both of its approved CAR-Ts saw sales declines as other products saw growth, a mixture of different competitive headwinds seems to be behind the disparities.

Finance Watch: Lilly Toes The $1 Trillion Valuation Line

 
• By Mandy Jackson

Public Company Edition: Lilly’s obesity franchise makes it the highest-valued health care company in the US. Also, Genmab accesses $4.5bn to fund its $8bn Merus buy, Moderna locks in a $1.5bn credit facility and Ionis sells $700m worth of notes.

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Pipeline Watch: Eight Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Sibeprenlimab’s US Accelerated Approval Drives IgAN Competition Forward

 
• By Lisa Takagi

Following US approval of its first-in-class drug for IgAN sibeprelimab, Otsuka is planning an sNDA for an autoinjector in 2026 and is in talks with regulatory authorities in Japan and Europe.

The Rise of China Biopharma – Five Themes In 2025

 
• By Andrew McConaghie

The growth of China’s biopharma sector has been perhaps the most significant sector trend this year – Scrip outlines five themes that have emerged during 2025 and in discussions at the recent Jefferies conference in London.