Policy Prescriptions: User Fees, EMA Worries, PBM Strategies, PRIME Milestones
The US has plenty of new pharma legislation, Europe has plenty of worries about EMA's Brexit move, pharmacy benefit managers give plenty more scrutiny to which products earn a place on formulary. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.
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Roivant will use the cash to fund other "Vants" that develop drugs or make the process more efficient. Also, Zealand launches its IPO, Apellis raises a $60m Series E and BioMarin tops recent offerings.
Bids For EMA Show East-West Split Over Principle of Fair Spread Of Agencies
Some countries in eastern Europe say that they should host the European Medicines Agency in order to respect the criterion of “geographical spread.” But many in western Europe say this principle should apply only to new agencies and that the criterion of business continuity at the EMA should take precedence.
Implementing User Fees Should Be Lighter Lift For FDA This Time Around; Bill Heads To White House
The 2017 user fee reauthorization bill contains provisions that should be significantly easier for the agency to implement compared with the 2012 measure. Senate clears clean bill for president's review.