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Financings Of The Fortnight: Is Buoyant Biotech IPO Scene Altering Private Biotech M&A Trends?

 
• By Alex Lash, Paul Bonanos, Amanda Micklus, and Chris Morrison

When the IPO spigot runs dry, there’s M&A aplenty, and when the IPO wine is flowing, M&A slows down, right? FOTF tackles some conventional wisdom; plus deals from Acadia, Neurocrine, Aquinox, and Human Longevity.

Despite a slight slowdown, there’s considerable cash already sloshing around the biotech IPO space. There’s (still!) plenty more stacked up in investor suitcases from California to the New York Island just waiting to back anything with a pulse. The momentum is here! This land grab is your land grab!

All of which should mean that biotech boards weighing exit options the past year or so have had choices that didn’t exist for most companies in the preceding four or five years (

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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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Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.