Biomarin's Aldurazyme (laronidase) receives a complete response letter Jan. 28. FDA asked for more information on "postmarketing commitments, final product labeling, and completion of the manufacturing inspections process," Biomarin said. FDA completed its pre-approval inspections, and no further inspections are scheduled. The company expects Aldurazyme's postmarketing commitments to follow the Endocrinologic & Metabolic Drugs Advisory Committee recommendations of antibody formation monitoring. The committee unanimously recommended FDA approve Aldurazyme as treatment for mucopolysaccharidosis I (1"The Pink Sheet" Jan. 20, p. 18)...
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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.’
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
