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FDA in the Shutdown: Drug Center Stays Open (Mostly); Ben Venue Does Not

 
• By Michael McCaughan

New drug approvals continued during the partial government shutdown, as user fees helped keep most of the FDA review functions running smoothly. The drug center did face some unusual challenges, including responding to a major manufacturing shutdown (by Ben Venue) – and to speculation about a leadership change at the drug center.

On October 8, FDA completed the first new drug application review that involved the full implementation of the review procedures adopted by the Prescription Drug User Fee Act for new molecular entities, when it approved Bayer AG’s Adempas (riociguat) for treatment of pulmonary hypertension.

Adempas is not the first application approved under the new “program” for new molecular entity reviews, but it is 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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BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

Brazil Could Look To Germany, UK And Australia For ATMP Drug Pricing Rules

 
• By Francesca Bruce

There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
• By Neena Brizmohun

Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.