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GSK’s Promacta Cleared For Use With Interferon In Hep C Patients

 
• By Shirley Haley

The new indication fills an unmet need in a population of patients who have a short window to cure chronic hepatitis C infection before liver damage becomes too great for treatment, but for whom interferon-based therapy – currently their only option - is not indicated because of low platelet levels.

GlaxoSmithKline PLC’s oral thrombocytopenia therapy Promacta (eltrombopag) received FDA approval as supportive care for a population of chronic hepatitis C patients lost in the flurry of activity around new and emerging antiviral therapies: those who don’t have time to wait for interferon-free regimens to be approved but are unable to take interferon because their blood platelet count is too low.

FDA cleared Promacta for treatment of patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy, GSK announced Nov. 19.

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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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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.