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Biopharma Out-licensing: 2012’s “In” Thing?

 
• By Ellen Licking

Talk to any Big Pharma business development executive about deal-making trends for more than 15 minutes and the word out-licensing is bound to crop up. Major drugmakers are moving beyond the rhetoric and actually giving up rights to individual assets that heretofore would have been deemed too valuable to merit out-licensing -- but with qualifications.

Talk to any Big Pharma business development executive about deal-making trends for more than 15 minutes and the word out-licensing is bound to crop up. It’s not hard to understand why: drugmakers face significant cost-constraints thanks to patent expirations and shrinking R&D budgets, and mid-stage pipelines are overly full in the wake of recent mega-mergers. As a result, says Doug Giordano, a VP of business development at Pfizer Inc., executives realize “it is now more attractive to outlicense assets than allow [them] to sit on the shelves.”

And certainly many different groups are bound to be interested in Big Pharma’s de-prioritized mid-stage assets. VCs in particular are eager to in-license clinically validated molecules in the hopes that...

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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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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.