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Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. Read More
The FDA’s Office of Pharmaceutical Quality (OPQ) finished out 2023 by progressing in all four of its strategic priorities: collaboration, communication, engagement, and innovation, according to its 2023 annual report. Read More
U.S. drugs in shortage have reached “record highs” and policymakers must address gaps in pharmaceutical supply chains to better prepare for future, unanticipated shocks, according to researchers from University of Pittsburgh School of Medicine. Read More
Following through on a 2023 pledge from its CEO, Amylyx is voluntarily pulling its controversial amyotrophic lateral sclerosis drug Relyvrio/Albrioza (AMX0035; ursodoxicoltaurine) after the drug failed its confirmatory phase 3 study. Read More
President Biden continued to push for extending the prescription drug cost-cutting provisions of the Inflation Reduction Act (IRA) beyond Medicare recipients in a speech broadcast on YouTube on Wednesday. Read More
The FDA questioned and answered virtually all aspects of Remote Regulatory Assessments (RRA) in an 18-page revised draft guidance issued last January, and the comments on the Q&A document have arrived with more questions of their own. Read More
This edition of Quick Notes reviews the regulatory and/or judicial status of four drugs, including an add-on therapy for a rare blood disorder, a drug to treat forms of pulmonary arterial hypertension, a new drug to treat a pediatric metabolic disorder and an IV maintenance drug for patients with early Alzheimer’s disease. Read More
Guest columnists Darius Lakdawalla and Charles Phelps write on the need for a new way to evaluate the value of drugs and therapies. Darius Lakdawalla is the Quintiles Chair in Pharmaceutical Development and Regulatory Innovation at the University of Southern California and cofounder of EntityRisk, and Charles Phelps is a professor at the University of Southern California and provost emeritus of the University of Rochester. Read More