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What’s In A Name? Janssen’s Loss Of Sovriad Was Gilead’s Gain With Sovaldi

 
• By Sue Sutter

FDA initially rejected both sponsors’ preferred proprietary names for their hepatitis C treatments due to the risk of confusion with each other. Janssen had to settle for Olysio, its backup name for simeprevir, leaving Gilead to claim title to its preferred name for sofosbuvir.

Janssen R&D LLC and Gilead Sciences Inc. were prepared to battle it out for market share in the increasingly competitive and highly lucrative hepatitis C arena. However, the companies found themselves in an unexpected, head-to-head regulatory battle over trade names in the run-up to approval of their respective antiviral compounds, Olysio (simeprevir) and Sovaldi (sofosbuvir).

The NDAs for simeprevir, an NS3/4A protease inhibitor, and sofosbuvir, a nucleotide analog NS5B polymerase inhibitor, were submitted just nine days apart and travelled a parallel review track in the...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

GLP-1 Pricing ‘Paradigm Shift’ Possible, But Would It Meet Trump’s MFN Goals?

 
• By Cathy Kelly

For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.