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FDA Actions, In Brief

 
• By Shirley Haley, Emily Hayes, and Sue Sutter

FDA ended the week with a flurry of activity, issuing a “complete response” letter, cancelling an advisory committee and approving several drugs.

FDA’s decision to grant regular, rather than accelerated, approval for GlaxoSmithKline PLC’sVotrient (pazopanib) in advanced soft tissue sarcoma suggests reviewers may have concluded that requiring a confirmatory study to assess symptom benefit would have been difficult to accomplish and not particularly useful. The April 26 approval, which did not include any new post-marketing requirements or post-marketing commitments, followed the Oncologic Drugs Advisory Committee’s overwhelming endorsement of pazopanib’s risk/benefit profile in STS Also see "Tale Of Two Sarcoma Drugs: ODAC Gives Nod To GSK’s Votrient, Thumbs Down On Merck/Ariad’s Taltorvic" - Pink Sheet, 20 March, 2012..

At the March 20 advisory committee meeting, FDA officials and panel members discussed the possibility of granting accelerated approval, with...

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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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EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
• By Eliza Slawther

There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

New EU Filings

 
• By Neena Brizmohun

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.