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Merck Partners With Korea’s Samsung Bioepis On Multiple Biosimilar Targets

 
• By Jessica Merrill

Samsung Bioepis will be responsible for development, manufacturing and registration, while Merck will be responsible for commercializing any resulting drugs. Merck says the partnership will complement the firm’s internal biologics portfolio.

Merck & Co. Inc. has signed Samsung Bioepis Co. Ltd. as its partner to develop multiple biosimilar candidates in a deal announced Feb. 20. Whether the announcement reinforces Merck’s commitment to the space or signals the company’s desire to reduce investment in the field by handing off development is unclear, but certainly the deal represents a change in strategy from how Merck entered the biosimilar race in 2008.

Merck declined to provide more insight on its biosimilar initiative, but said the deal with Samsung Bioepis is just one...

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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.

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• By Nielsen Hobbs

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• 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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Opuni Appointed Acting CEO Of Ghana’s FDA As Darko Leaves To Lead African Medicines Agency

 
• By Anabel Costa-Ferreira

Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.

UK HRA Working On ‘Trusted’ Path Forward To Support Simplified Informed Consent

 
• By Vibha Sharma

The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.

EU Ups Ante On Stockpiling For Crises

 
• By Francesca Bruce

The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.