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2012’s Top Biopharma Dealmakers

 
• By Amanda Micklus

AstraZeneca was the top in-licenser, snagging a $3.4 billion pact with BMS for Amylin’s diabetes assets, making metabolic diseases the leading therapeutic area in biopharma alliances.

Despite a challenging year in dealmaking, in which 2012 turned in fewer licensing deals than any year in recent memory and led to smaller upfront commitments combined with large milestones payouts, the year nonetheless produced several deals and trends of note Also see "In 2012, Buyer’s Market Made Alliances Rarer" - Pink Sheet, 7 January, 2013..

Bristol-Myers Squibb Co.’s $6.8 billion acquisition of Amylin Pharmaceuticals Inc. gave way to one of the biggest alliances...

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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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US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
• By Sue Sutter

Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."

World’s First Hemato-Oncology Microbiota Therapeutic Among Latest New EU Filings

 
• By Neena Brizmohun

The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
• By Vibha Sharma

The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.