Centocor Ortho Biotech's Stelara (ustekinumab) brings a novel mechanism and superior efficacy to the plaque psoriasis marketplace, but in terms of risk management, the anti-inflammatory biologic differs little from the tumor necrosis factor inhibitor class
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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.’
With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
