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With Alkermes’ Transition Well Under Way, Commercial Expansion Is Next

 
• By Jessica Merrill

As Alkermes advances its proprietary pipeline, the company is beginning to build its commercial organization ahead of what will be the launch of its first wholly owned drug since it took the marketing reins with Vivitrol in 2008.

Alkermes PLC is making strides advancing its proprietary pipeline and expects to file an NDA later this year for what will be its first solely marketed drug since it took commercial control of Vivitrol (naltrexone) in 2008. The most advanced drug in the company’s pipeline is a long-acting injectable (LAI) form of the marketed antipsychotic Abilify (aripiprazole), which could reach the market in 2015 for the treatment of schizophrenia. In preparation, Alkermes is looking to build out its commercial ranks.

Aripiprazole lauroxil would be the first drug Alkermes proactively markets on its own under a new strategy to build a proprietary drug portfolio, transitioning from a primarily manufacturing and royalty...

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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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FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 
• By Derrick Gingery

The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.