Harkin, Hatch Reload In Hunt For Full DSHEA Funding, Implementation
• By The Tan Sheet
The supplement industry's staunchest allies in the Senate, Tom Harkin and Orrin Hatch, introduce a bill aimed at fully funding dietary supplement regulation and timed to deflect criticism of the industry from a committee hearing
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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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Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.