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Financings Of The Fortnight: Haircuts And Postponements Increasing As IPO Burst Slows Down

 
• By Alex Lash

The IPO boom of 2013 is showing signs of slowing, while class of 2012 companies are seeing stock prices decline. Plus news on recent financings by Relypsa, Synta Pharmaceuticals, ArGEN-X and Karyopharm Therapeutics.

With initial public offerings still the talk of the town, the relative lack thereof the past couple weeks in our little corner of the world was noticeable.

But “haircuts” have been in the news for biotech lately, after a summer of letting it all hang out. Considered the highest profile of the current road-show warriors, Relypsa Inc. finally priced Nov. 14 after a couple of downgrades – or, if you prefer, a haircut. (For more, see our roundup below.) Antibody firm Xencor Inc

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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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Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.