1. Pink Sheet
  2. >>Archive

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Archive

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.’

More from Pink Sheet

A Record Year For US FDA Approvals? Commissioner Says It’s Possible

 
• By Michael McCaughan

FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?

PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
• By Eliza Slawther

PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.

Italy To Reward Locally Conducted R&D In Innovative Medicines Fund Revamp

 
• By Francesca Bruce

Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.