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CDER plans to start using a new informatics platform for new drug approvals in October, following the processes already in place for generic drug reviews, says CDER Director Janet Woodcock. Read More
The FDA has asked Scynexis to hold new clinical studies of an intravenous formulation of its antifungal treatment, SCY-078, until the agency can review available pre-clinical and clinical data. Read More
A UK patent court invalidated two of AbbVie’s Humira patents — clearing a major barrier for drugmakers seeking EU approvals for biosimilar versions of the blockbuster arthritis treatment. Read More
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More
Two groups of senators have launched investigations into orphan drugs to examine whether drugmakers are misusing the designation and overcharging for treatments. Read More