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Shire Buys FerroKin BioSciences To Further Hematology Strategy

 
• By Jessica Merrill

Shire gains an iron chelator in Phase II development in exchange for $100 million upfront and post-closing milestones of $225 million.

Shire PLC is expanding its hematology business with the acquisition of FerroKin Biosciences, Inc., a San Francisco biotech with an iron chelator in Phase II development. The company announced the acquisition March 15 for an upfront payment of $100 million and potential post-closing milestones of $225 million.

The acquisition announcement comes one day after Shire said it has withdrawn its U.S. BLA for Replagal (agalsidase alfa) for...

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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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Why Chiesi’s Raxone Faced A Decade-Long Wait For English Funding

 
• By Eliza Slawther

Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.

Europe Eyes First Therapies For PSC And cALD In Latest EMA Drug Filings

 
• By Neena Brizmohun

Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.

New Advisory Group To Shape UK’s Simplified Informed Consent Process

 
• By Anabel Costa-Ferreira

Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access