FDA's new leadership should focus on improving "regulatory predictability" for orphan drug development, Social Security Administration Commissioner Michael Astrue said during a discussion of orphan drug policy sponsored by Shire Pharmaceuticals, the National Chamber Foundation and the U.S. Chamber of Conference in Washington, D.C. June 4
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
In line with new President Lee’s campaign pledges, South Korea's newly confirmed health minister is expected to tackle key issues including a prolonged doctors' conflict, essential drug supplies and R&D support for the industry.
The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.
Meanwhile, companies continue discussions with the Trump Administration over ways of increasing what European nations pay for drugs as an alternative to imposing a Most Favored Nation drug pricing policy in the US.
